Prozac side effects for men


Side effects and how to manage them

Prozac (fluoxetine) is a brand-name prescription medication. The Food and Drug Administration (FDA) has approved it to treat the following conditions in adults:

  • major depressive disorder (MDD)
  • obsessive compulsive disorder (OCD)
  • bulimia nervosa
  • panic disorder with or without agoraphobia

In addition, Prozac can also be used in combination with olanzapine (Zyprexa) to treat the following conditions in adults:

  • depression related to bipolar disorder
  • depression if other medications aren’t working for you

Prozac can also be used in certain children with MDD, OCD, or in combination with olanzapine for depression related to bipolar disorder.

Here are some fast facts about Prozac:

  • Active ingredient: fluoxetine
  • Drug class: selective serotonin reuptake inhibitor (SSRI)
  • Drug form: oral capsule

In most cases, if Prozac works for you, your doctor will recommend taking it long-term. However, in some cases, your doctor may recommend short-term treatment. Before you start Prozac, your doctor will discuss your treatment plan with you.

As with other drugs, Prozac can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Prozac, including details about its uses, see this article.

Prozac can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Prozac in clinical trials:

  • abnormal dreams
  • anxiety
  • diarrhea
  • dry mouth
  • weakness
  • sexual side effects, such as decreased libido*

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Prozac use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Prozac’s prescribing information.

Mild side effects that have been reported with Prozac include:

  • anxiety
  • diarrhea
  • dry mouth
  • weakness
  • heartburn
  • flu-like symptoms
  • insomnia
  • nervousness
  • rash
  • sleepiness
  • dizziness
  • sweating
  • tremor
  • loss of appetite, which can lead to weight loss
  • sexual side effects, such as decreased libido*
  • nausea*
  • headache*
  • hair loss*
  • mild allergic reaction*

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Prozac and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Prozac may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Prozac’s prescribing information.

If you develop serious side effects while taking Prozac, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

  • Serotonin syndrome (a buildup of serotonin in your body). Symptoms can include:
    • confusion
    • fast heartbeat
    • rigid or twitching muscles
    • headache
  • Bleeding. Symptoms can include:
    • bruising easier than usual
    • nosebleeds
    • black, tarry stool
    • abdominal pain
  • Glaucoma. Symptoms can include:
    • headache
    • blurry vision
    • nausea or vomiting
  • Seizures. Symptoms can include:
    • uncontrolled movements of the arms or legs
    • unconsciousness
    • confusion
  • Low blood sodium levels. Symptoms can include:
    • nausea or vomiting
    • headache
    • seizures
  • Heart rhythm changes, such as QT prolongation. Symptoms can include:
    • dizziness
    • heart palpitations
    • fainting
  • Mania (episodes of unusually high energy that affects your mood and behavior). Symptoms can include:
    • agitation (feeling annoyed or restless)
    • hallucinations
    • racing thoughts
  • Increased risk of suicidal thoughts and behaviors in certain people.*
  • Severe allergic reaction.†

* Prozac has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section below.
†An allergic reaction is possible after using Prozac. However, it’s not clear whether this side effect occurred in clinical trials. To learn more, see the “Side effect specifics” section below.

Prozac is approved to treat certain children and adults. However, the drug has a boxed warning for the risk of for the risk of suicidal thoughts and behaviors in certain people. Boxed warnings are the most serious warnings recommended by the FDA. The purpose of a boxed warning is to make patients and doctors aware of the risk of taking a medication.

Specifically, Prozac may increase the risk of suicidal thoughts and behaviors in children or young adults taking the drug. For more information on this warning, see the “Side effects specifics” section below.

Prozac is approved to treat the following conditions in children:

  • ages 8 and older with major depressive disorder (MDD)
  • ages 7 and older with obsessive-compulsive disorder (OCD)
  • ages 10 and older with depression related to bipolar disorder

In most cases, children taking Prozac reported the same side effects that adults taking the drug experienced. Prozac side effects in teens were also usually the same as the side effects in adults. However, children taking Prozac may experience other side effects, such as feeling thirsty, muscle spasms, or urinary frequency.

In addition, it’s not known if the drug may have long-term effects on the growth or development of children. So, doctors may monitor your child’s height and weight to be sure that they’re growing as they should be while taking Prozac.

If you have concerns about side effects that your child may experience from taking Prozac, talk with their doctor.

You shouldn’t experience weight gain from taking Prozac. Weight gain wasn’t reported in clinical trials of people taking this drug.

In fact, weight loss was actually a side effect of this medication in clinical trials. This may be because Prozac can cause a decrease in appetite, which may lead to weight loss.

However, it’s possible for depression to cause weight gain to occur. Prozac can be used to treat depression.

So, if you notice weight gain during your treatment with Prozac, talk with your doctor. They can help you determine what may be causing the weight gain to occur. In addition, they may be able to recommend ways to help manage your weight.

Often, females* and males* taking Prozac will experience similar side effects. However, it’s possible for sexual side effects to occur from taking Prozac. Sexual side effects may differ between females and males.

For example, in males, Prozac may cause a decreased libido, erectile dysfunction, or a delay or trouble ejaculating. However, in females, this drug may decrease libido or cause a delay in orgasm.

For more information on sexual side effects that Prozac may cause, see the “Side effect details” section below.

* Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

Prozac may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Does stopping Prozac treatment cause withdrawal symptoms?

Yes, it’s possible that stopping treatment with Prozac may cause withdrawal symptoms to occur. Withdrawal symptoms are symptoms that can happen when your body is used to taking a medication that you suddenly stop taking.

Some examples of withdrawal symptoms that may occur from stopping Prozac include:

  • mood changes, such as irritability or agitation
  • dizziness
  • tingling of the arms or legs
  • confusion
  • headache
  • insomnia

Because of these side effects, be sure to talk with your doctor before stopping treatment with Prozac. They’ll likely recommend slowly decreasing your dose of Prozac so that your body can adjust to the change.

If you’re interested in stopping treatment with Prozac, talk with your doctor about the safest way to do so.

What are the long-term side effects of Prozac?

Although uncommon, it’s possible for Prozac to cause long-term side effects to occur. Examples of long-term side effects that Prozac may cause include glaucoma, seizures, or hair loss.

If you’re concerned about long-term side effects from Prozac, talk with your doctor or pharmacist. They can discuss the risk of side effects with you and ways to help prevent side effects from occurring.

Are there side effects with a low dose of Prozac?

Yes, it’s possible to experience side effects if you take a low dose of Prozac. This drug is available in 10 milligram (mg), 20 mg, or 40 mg capsules. Taking even a low dose of Prozac may cause side effects to occur.

The lowest dose of Prozac that your doctor may prescribe for you is 10 mg. And, although higher doses of Prozac may have a higher risk of side effects, you still may experience side effects from lower doses.

If you’re concerned about side effects that you may experience from Prozac, talk with your doctor or pharmacist. They may be able to help recommend ways to reduce side effects that you experience. For example, if you’re concerned about Prozac 20 mg side effects, your doctor or pharmacist may be able to recommend ways to reduce side effects from occurring.

Prozac doesn’t have a high risk for misuse. Misuse of a drug means using it in a way that’s different than how the drug was prescribed to you. Misusing a drug may increase your risk of serious side effects and overdose.

However, even though Prozac isn’t commonly misused, stopping the drug suddenly may cause withdrawal symptoms. Withdrawal symptoms can happen if your body is used to a medication that you suddenly stop taking.

To learn more about withdrawal symptoms that may occur from Prozac, see the “FAQs about the side effects of Prozac” section above.

Learn more about some of the side effects that Prozac may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Prozac.

Increased risk of suicidal thoughts and behaviors

It’s possible for Prozac to increase the risk of suicidal thoughts and behaviors in certain people. In fact, Prozac has a boxed warning for this risk. A boxed warning is the most serious warning recommended by the FDA. The purpose of a boxed warning is to alert doctors and patients about the risks of taking a medication.

Antidepressants, including Prozac, have a boxed warning for the risk of suicidal thoughts and behaviors. This risk was seen in children and young adults ages 24 and younger taking the drug. The risk of this side effect is highest when you first start taking Prozac or when your dose of medication is increased.

It’s important to note that this risk was seen in people taking Prozac short-term. So, it’s not known if taking this drug long-term may still have this risk.

What you can do

Because of the risk of suicidal thoughts and behaviors, your doctor will likely recommend monitoring you throughout your treatment with Prozac. They may monitor you for increasing symptoms of depression, changes in behavior, or suicidal thoughts or behaviors. If you develop these symptoms, your doctor may recommend stopping Prozac and trying a different medication.

In addition, be sure to report any changes in mood to your doctor right away. Your doctor may also recommend that your family or loved ones watch for changes in behavior that may indicate worsening depression or suicidal thoughts or behaviors.

Sexual side effects

It’s possible for selective serotonin reuptake inhibitors (SSRIs), including Prozac, to cause sexual side effects. In fact, sexual side effects from Prozac were commonly reported in clinical trials of people taking the drug.

Examples of sexual side effects can include:

  • decreased libido
  • delayed or trouble with orgasm or ejaculation
  • erectile dysfunction
What you can do

If you notice sexual side effects during your treatment with Prozac, talk with your doctor. They may be able to recommend ways to manage sexual side effects that you experience. For example, your doctor may recommend Viagra (sildenafil) to treat erectile dysfunction that you experience from Prozac treatment.

Headache

You may experience headaches from taking Prozac. Although headaches weren’t one of the most common side effects in clinical trials of Prozac, they may occur.

What you can do

Tell your doctor if you’re experiencing headaches during your treatment with Prozac. Although rare, it’s possible for headaches to be due to other side effects of Prozac, including low blood sodium levels or serotonin syndrome. Your doctor will be able to help you determine what’s causing your headaches to occur.

In some cases, your doctor may recommend taking an over-the-counter medication, such as Tylenol (acetaminophen) to treat your headaches. If you’re experiencing headaches during your treatment with Prozac, talk with your doctor.

Nausea

You may experience nausea from taking Prozac. In fact, nausea was one of the most common side effects reported in clinical trials of Prozac.

What you can do

If you experience nausea from taking Prozac, talk with your doctor or pharmacist. They may be able to recommend ways to decrease this side effect from occurring. For example, in some cases, taking a medication with food may decrease nausea that you experience.

Hair loss

It’s possible to have hair loss from taking Prozac. Although hair loss wasn’t a common side effect reported in clinical trials, it can occur.

What you can do

If you notice hair loss during your treatment with Prozac, talk with your doctor or pharmacist. They may be able to recommend ways to reduce this side effect from occurring. For example, they may recommend using an over-the-counter medication, such as Rogaine (minoxidil) to manage hair loss.

Allergic reaction

As with most drugs, Prozac can cause an allergic reaction in some people. However, it’s not clear whether this side effect occurred in clinical trials.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Prozac. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Click here for more links and local resources.

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Before you start treatment with Prozac, be sure to tell your doctor about any medical conditions that you have. They can help determine if Prozac is safe for you.

Boxed warning: Increased risk of suicidal thoughts and behaviors

This drug has a boxed warning for increased risk of suicidal thoughts and behaviors. This is a serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you take Prozac. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Mood conditions. If you have any mood problems, such as bipolar disorder, tell your doctor before taking Prozac. In some cases, it’s possible for Prozac to increase the risk of manic episodes occurring in people with certain mood conditions. If you have a mood condition, your doctor can help determine whether Prozac is safe for you.

Seizures. If you have seizures, tell your doctor before taking Prozac. It’s possible for Prozac to increase your risk of seizures occurring. And, if you already have a seizure disorder, taking Prozac may raise your risk of having a seizure. If you have a seizure condition, your doctor can advise you on whether it’s safe for you to take Prozac.

Glaucoma. It’s possible for Prozac to increase the pressure in your eye, which can make glaucoma worse. So, if you have glaucoma, talk with your doctor to see whether Prozac is safe for you.

Heart conditions. If you have any heart problems, such as an arrhythmia, tell your doctor before taking Prozac. This medication can increase your risk of heart rhythm changes occurring. And, if you already have a heart condition, taking Prozac may make your condition worse. In this case, your doctor can help determine whether Prozac may be safe for you.

Bleeding conditions. Prozac may increase your risk of bleeding. If you have a bleeding condition, taking Prozac may make it even easier for you to bleed. Tell your doctor about any bleeding conditions that you have before taking Prozac.

Allergic reaction. If you’ve had an allergic reaction to Prozac or any of its ingredients, your doctor will likely not prescribe Prozac. Ask your doctor what other medications may be better options for you.

Liver problems. Prozac is removed from your body by your liver. If your liver isn’t functioning properly, it’s possible for Prozac to build up in your body. This can increase your risk of side effects from the drug. Talk with your doctor if you have liver problems before starting treatment. They may recommend a lower dose of Prozac for you.

Low electrolyte levels. Prozac may decrease sodium (salt) levels in your blood. If you have an electrolyte condition such as low blood sodium levels, taking Prozac may increase your risk of side effects. In addition, Prozac may increase your risk of developing a heart side effect such as increased heart rate if you have an electrolyte condition.

If you have low electrolyte levels talk with your doctor before starting treatment with Prozac. They’ll likely recommend managing your electrolyte levels before starting Prozac.

Older adults. It’s possible that older adults (age 65 years or older) taking Prozac may be at an increased risk of side effects, such as low blood sodium levels. If you’re an older adult, your doctor may monitor you more often for side effects while you’re taking Prozac.

Electroconvulsive therapy. It’s possible that if you receive electroconvulsive therapy (ECT) for treatment-resistant depression, you may be at an increased risk of seizures from taking Prozac. So, if you receive ECT, talk with your doctor to see whether it’s safe for you to take Prozac.

Diabetes. If you have diabetes, taking Prozac can cause changes in your blood sugar to occur. This may make your diabetes worse and can increase your risk of developing low blood sugar. Due to this risk, if you have diabetes, your doctor may recommend more frequent monitoring of your blood sugar while you’re taking Prozac.

Alcohol with Prozac

There aren’t any known interactions between Prozac and alcohol.

However, drinking alcohol while you’re taking Prozac may increase your risk of side effects from the drug. For example, both Prozac and alcohol may cause:

  • nausea
  • headache
  • dizziness
  • sleepiness

Talk with your doctor to see if it’s safe for you to drink alcohol while taking Prozac.

Pregnancy and breastfeeding while taking Prozac

It may not be safe to take Prozac during pregnancy or while breastfeeding.

Selective serotonin reuptake inhibitors (SSRIs), including Prozac, may increase the risk of certain developmental problems. These can include difficulty breathing, trouble feeding, or irritability. In addition, the drug may increase the risk of pulmonary hypertension (high pressure in the lungs) in a newborn.

At this time, it’s not known if Prozac may increase the risk of congenital anomalies (commonly known as birth defects). There’s currently a pregnancy registry for antidepressant drugs, such as Prozac. The purpose of a pregnancy registry is to collect information on the risks of taking a drug during pregnancy. You can sign up for the registry online or by calling 844-405-6185.

In addition, it’s important to note that untreated depression may also have effects on a developing fetus. So, if you’re pregnant or planning to become pregnant, talk with your doctor before taking Prozac. They can help determine what the best treatment plan is for you.

Prozac can pass into breast milk, so a breastfeeding baby can be exposed to the drug. Babies exposed to Prozac may experience side effects such as agitation, irritability, and trouble feeding.

If you’d like to breastfeed while taking Prozac, talk with your doctor. They can help determine if breastfeeding may be safe for your baby.

Side effects with Prozac may occur, but they’re usually mild. However, it’s also possible for this drug to cause serious side effects.

If you’d like to learn more about Prozac, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

  • More information about Prozac. For details about other aspects of Prozac, refer to this article.
  • Drug comparison. Learn how Prozac compares with Zoloft and Lexapro.
  • A look at your condition. For details about your condition, see our mental health hub.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Prozac Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

Warnings:

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

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Uses

Fluoxetine is used to treat depression, panic attacks, obsessive compulsive disorder, a certain eating disorder (bulimia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder).This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. It may also reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, and checking) that interfere with daily living. Fluoxetine may lessen premenstrual symptoms such as irritability, increased appetite, and depression. It may decrease binging and purging behaviors in bulimia.

How to use Prozac

Read the Medication Guide provided by your pharmacist before you start using fluoxetine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily in the morning. If you are taking this medication twice a day, your doctor may direct you to take it in the morning and at noon.

If you are taking fluoxetine for premenstrual problems, your doctor may direct you to take it every day of the month or just for the 2 weeks before your period through the first full day of your period. To help you remember, mark your calendar.

If you are using the liquid form of this medication, measure the dose carefully using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Keep taking this medication even if you feel well. Do not stop taking this medication without first consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.

You should see some improvement in 1 to 2 weeks. It may take 4 to 5 weeks before you feel the full benefit.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

See also Warning section.

Nausea, drowsiness, dizziness, anxiety, trouble sleeping, loss of appetite, tiredness, sweating, or yawning may occur. If any of these effects last or get worse, tell your doctor promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual or severe mental/mood changes (such as agitation, unusual high energy/excitement, thoughts of suicide), easy bleeding/bruising, muscle weakness/spasm, shakiness (tremor), decreased interest in sex, changes in sexual ability, unusual weight loss.

Get medical help right away if you have any very serious side effects, including: black stools, vomit that looks like coffee grounds, seizures, signs of kidney problems (such as change in the amount of urine), eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night, blurred vision).

If you have diabetes, fluoxetine may affect your blood sugar levels. Monitor your blood sugar regularly and share the results with your doctor. Your doctor may need to adjust your medication, diet, and exercise when you start or stop fluoxetine.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking fluoxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of bipolar/manic-depressive disorder, personal or family history of suicide attempts, liver problems, diabetes, low sodium in the blood (such as may occur while taking "water pills" - diuretics), severe dehydration, seizures, intestinal ulcers/bleeding (peptic ulcer disease), personal or family history of glaucoma (angle-closure type).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

The liquid form of this medication contains alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Some medications (such as metronidazole, disulfiram) can cause a serious reaction when combined with alcohol. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially weight loss. Monitor weight and height in children who are taking this drug.

Older adults may be more sensitive to the side effects of this drug, especially bleeding and loss of coordination. Loss of coordination can increase the risk of falling. Older adults may also be more likely to develop low sodium in the blood, especially if they are taking "water pills" (diuretics).

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Also, babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.

Since untreated mental/mood problems (such as depression, panic attacks, obsessive compulsive disorder) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Fluoxetine can stay in your body for many weeks after your last dose and may interact with many other medications. Before using any medication, tell your doctor or pharmacist if you have taken fluoxetine in the previous 5 weeks.

Some products that may interact with this drug are: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as dabigatran/warfarin).

Taking MAO inhibitors with his medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for 2 weeks before and at least 5 weeks after treatment with this medication. Ask your doctor when to start or stop taking this medication.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include pimozide, thioridazine, vinblastine, antiarrhythmics (such as propafenone, flecainide), tricyclic antidepressants (such as desipramine, imipramine), among others.

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including other SSRIs such as citalopram/paroxetine, SNRIs such as duloxetine/venlafaxine), tryptophan, among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson's disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

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Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, severe dizziness, fainting.

Do not share this medication with others.

Keep all regular medical and psychiatric appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

Prozac 20 mg capsule

Color: green,off-whiteShape: oblongImprint: DISTA 3105 PROZAC 20 mg

This medicine is a green off-white, oblong, capsule imprinted with "DISTA 3105" and "PROZAC 20 mg".

Prozac 10 mg capsule

Color: greenShape: oblongImprint: DISTA 3104 PROZAC 10 mg

This medicine is a green off-white, oblong, capsule imprinted with "DISTA 3105" and "PROZAC 20 mg".

Prozac 40 mg capsule

Color: green,orangeShape: oblongImprint: DISTA 3107 PROZAC 40 mg

This medicine is a green off-white, oblong, capsule imprinted with "DISTA 3105" and "PROZAC 20 mg".

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Prozac instructions for use: indications, contraindications, side effects - description of Prozac Capsules (694)

💊 Ingredients of Prozac ®

✅ How to use Prozac ®


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Description of the active ingredients of the preparation Prozac ® (Prozac ® )

The scientific information provided is general and cannot be used to make decisions. decisions about the use of a particular drug.

Update date: 2020.06.09

Marketing authorization holder:

ELI LILLY VOSTOK, S.A. (Switzerland)

Made:


PATHEON FRANCE, S.A.S. (France)

ATX code: N06AB03 (Fluoxetine)

Active substance: fluoxetine (fluoxetine)

Rec.INN WHO registered

Dosage form


Prozac ®

Caps. 20 mg: 14 or 28 pcs.

reg. No.: P N014206/01 dated 17.03.08 - Indefinitely

Release form, packaging and composition Prozac

®

Capsules hard gelatin capsules, size #3, opaque, green/cream, imprinted with the LILLY logo and the identification code "3105"; the contents of the capsules are white powder.0008

Excipients : starch, dimethicone.

Composition of the capsule shell: patented blue dye (patent blue V dye), iron oxide yellow dye, titanium dioxide, gelatin, food ink (for identification printing).

14 pcs. - blisters (1) - packs of cardboard.
14 pcs. - blisters (2) - packs of cardboard.

Clinical and pharmacological group: Antidepressant

Pharmacotherapeutic group: Antidepressant

Pharmacological action

Antidepressant, propylamine derivative. The mechanism of action is associated with selective blockade of neuronal reuptake of serotonin in the CNS. Fluoxetine is a weak antagonist of cholino-, adreno- and histamine receptors. Unlike most antidepressants, fluoxetine does not appear to cause a decrease in the functional activity of postsynaptic β-adrenergic receptors. Helps improve mood, reduces feelings of fear and tension, eliminates dysphoria. Does not cause sedation. When taken in average therapeutic doses, it practically does not affect the functions of the cardiovascular and other systems.

Pharmacokinetics

Absorbed from the gastrointestinal tract. Weakly metabolized during the "first pass" through the liver. Eating does not affect the degree of absorption, although it may slow down its rate. C max in plasma is achieved after 6-8 hours. C ss in plasma is achieved only after continuous administration for several weeks. Protein binding 94.5%. Easily penetrates through the BBB. It is metabolized in the liver by demethylation to form the main active metabolite of norfluoxetine.

T 1/2 fluoxetine is 2-3 days, norfluoxetine is 7-9 days. Excreted by the kidneys 80% and through the intestines - about 15%.

Indications of the active substances of the drug Prozac

®

Depression of various origins, obsessive-compulsive disorders, bulimic neurosis.

Open list of ICD-10 codes

F31 Bipolar affective disorder
F32 Depressive episode
F33 Recurrent depressive disorder
F41.2 Mixed anxiety and depressive disorder
F42 Obsessive-compulsive disorder
F50. 2 Bulimia nervosa

Dosing regimen

The method of administration and dosing regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.

Initial dose - 20 mg 1 time / day in the morning; if necessary, the dose can be increased after 3-4 weeks. The frequency of admission is 2-3 times / day.

The maximum daily oral dose of for adults is 80 mg.

Side effects

From the side of the central nervous system: possible anxiety, tremor, nervousness, drowsiness, headache, sleep disturbances.

From the digestive system: possible diarrhea, nausea.

From the side of metabolism: may increase sweating, hypoglycemia, hyponatremia (especially in elderly patients and with hypovolemia).

From the reproductive system: decreased libido.

Allergic reactions: possible skin rash, itching.

Other: joint and muscle pain, shortness of breath, fever.

Contraindications for use

Glaucoma, bladder atony, severe renal dysfunction, benign prostatic hyperplasia, simultaneous administration of MAO inhibitors, convulsive syndrome of various origins, epilepsy, pregnancy, lactation, hypersensitivity to fluoxetine.

Use in pregnancy and lactation

Contraindicated in pregnancy and lactation.

Use in hepatic impairment

Use with extreme caution in patients with hepatic impairment.

Use in impaired renal function

Contraindicated in severe renal impairment. Use with extreme caution in patients with moderate and mild renal impairment.

Use in children

The safety of fluoxetine in children has not been established.

Use in elderly patients

Elderly patients require dosage adjustment.

Special instructions

Use with extreme caution in patients with impaired liver and kidney function, with a history of epileptic seizures, cardiovascular diseases.

In patients with diabetes mellitus, changes in blood glucose levels are possible, which requires correction of the dosing regimen of hypoglycemic drugs. When used in debilitated patients while taking fluoxetine, the likelihood of developing epileptic seizures increases.

With the simultaneous use of fluoxetine and electroconvulsive therapy, the development of prolonged epileptic seizures is possible.

Fluoxetine can be used no earlier than 14 days after discontinuation of MAO inhibitors. The period after the abolition of fluoxetine before the start of therapy with MAO inhibitors should be at least 5 weeks.

Elderly patients require dosage adjustment.

The safety of fluoxetine in children has not been established.

Do not drink alcohol during treatment.

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, one should refrain from potentially hazardous activities that require increased attention and rapid psychomotor reactions.

Drug interactions

When used simultaneously with drugs that have a depressant effect on the central nervous system, with ethanol, a significant increase in the inhibitory effect on the central nervous system, as well as an increase in the likelihood of convulsions, is possible.

With simultaneous use with MAO inhibitors, furazolidone, procarbazine, tryptophan, serotonin syndrome may develop (confusion, hypomania, restlessness, agitation, convulsions, dysarthria, hypertensive crisis, chills, tremor, nausea, vomiting, diarrhea).

With simultaneous use, fluoxetine inhibits the metabolism of tricyclic and tetracyclic antidepressants, trazodone, carbamazepine, diazepam, metoprolol, terfenadine, phenytoin, which leads to an increase in their concentration in blood serum, an increase in their therapeutic and side effects.

With simultaneous use, inhibition of the biotransformation of drugs metabolized with the participation of the CYP2D6 isoenzyme is possible.

When used simultaneously with hypoglycemic agents, their effect may be enhanced.

There have been reports of increased effects of warfarin when co-administered with fluoxetine.

When used simultaneously with haloperidol, fluphenazine, maprotiline, metoclopramide, perphenazine, periciazine, pimozide, risperidone, sulpiride, trifluoperazine, cases of extrapyramidal symptoms and dystonia have been described; with dextromethorphan - a case of the development of hallucinations is described; with digoxin - a case of increasing the concentration of digoxin in the blood plasma.

When used simultaneously with lithium salts, an increase or decrease in the concentration of lithium in the blood plasma is possible.

With simultaneous use, it is possible to increase the concentration of imipramine or desipramine in the blood plasma by 2-10 times (may persist for 3 weeks after fluoxetine is discontinued).

When used simultaneously with propofol, a case is described in which spontaneous movements were observed; with phenylpropanolamine - a case is described in which dizziness, weight loss, hyperactivity were observed.

Co-administration may enhance the effects of flecainide, mexiletine, propafenone, thioridazine, zuclopenthixol.


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If you want to place a link to the description of this drug - use this code Prozac ® . Description of the drug in the reference book Vidal.

Side effects of Prozac - articles "Verimed"

Contents:

  1. Mechanism of action of Prozac
  2. Causes of adverse reactions
  3. Side effects of Prozac
  4. Contraindications for use
  5. Ways to minimize the side effects of Prozac

Prozac, or fluoxetine, is an antidepressant that belongs to the group of selective serotonin reuptake inhibitors. The drug also has anti-anxiety, dysphoric and anorexigenic properties. Taking the medicine improves mood, relieves anxiety and attacks of fear, but does not have sedative reactions and does not contribute to the development of orthostatic hypotension.

As with the use of any antidepressant, the side effects of Prozac suggest certain limitations in the use of the drug and caution in patients with contraindications. To better understand the causes of adverse reactions, you need to familiarize yourself with the principle of the influence of the drug, its pharmacological and recreational properties.

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The mechanism of action of Prozac

This bicyclic antidepressant belongs to propylamine derivatives. Its medicinal qualities are mainly based on selective or selective inhibition of serotonin reuptake. This increases the concentration of this neurotransmitter in the brain, which provides a stimulating effect on the central nervous system.

Prozac slightly affects cholinergic and histamine receptors, as well as dopamine and norepinephrine reuptake. When administered orally, the pharmacological agent is absorbed through the digestive system, the bioavailability of the drug reaches 60%.

The compound has the ability to accumulate in tissues , because of this, side effects appear for a longer period than its analogues. The features of the non-linear pharmacokinetics of the drug explain the disproportionate increase in the content of the substance in the blood when using high doses.

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Causes of adverse reactions

The prerequisites for the formation of undesirable effects in antidepressant treatment are not necessarily associated with a violation of the drug therapy regimen and exceeding the permissible dosage. The main factors leading to the occurrence of side effects of Prozac:

  • genetic predisposition;
  • individual intolerance;
  • metabolic disorder;

  • reduced immune defense;
  • presence of chronic diseases;
  • incompatibility with other drugs;
  • deviation from medical recommendations.

If the drug is taken by patients with motor or emotional agitation, increased anxiety, drowsiness or insomnia, then unwanted symptoms appear more pronounced, and previously diagnosed disorders only worsen.

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Side effects of Prozac

Undesirable reactions occur with long-term use of fluoxetine due to various factors. Specialists distinguish the following main manifestations:

  1. Disorders of the central nervous system: headaches, dizziness, weakness, asthenia, anxiety, tremors in the limbs, loss of balance, sleep disorders, aggression, manic and paranoid syndrome, depression and suicidal thoughts .
  2. Digestive problems: dry mouth, bouts of nausea and vomiting, diarrhea, loss of appetite leading to anorexia.
  3. Allergic reactions: skin rash, itching, redness.
  4. Complications of reproductive functions: lack of sexual desire, problems with erection, ejaculation and conception, pain in the mammary glands.
  5. Visual impairment: loss of acuity and ability to concentrate;
  6. Joint pain and muscle spasms, excessive sweating and hypoglycemia.
  7. Dysfunctions of the respiratory organs, excretory system and liver.

Prozac use is infrequent but does cause neuroleptic malignant syndrome, which is a deadly condition. Withdrawal symptoms may also occur when an antidepressant is discontinued.

Fluoxetine has a longer half-life than its counterparts, so withdrawal symptoms will be mild but may be delayed. The person suffers from:

  • headaches,
  • nervousness,
  • lethargy,
  • digestive disorders,
  • asthenia,
  • tremors,
  • arrhythmias,
  • pressure surges,
  • nightmares,
  • panic attacks and manic thoughts.

To prevent withdrawal, antidepressants are not stopped abruptly, but by gradually reducing the dose over a period of a month or longer.

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Aleksey Vladimirovich Bulkin
General Director of the VERIMED Clinic, Psychiatrist-narcologist

Contraindications for use

To prevent unpleasant consequences for mental and physical health , it is necessary to take into account the existing limitations in the treatment of fluoxetine. Among them:

  • individual intolerance to the agent;
  • use of MAO inhibitors;
  • manic manifestations;
  • epileptic seizures;
  • glaucoma and convulsions;
  • severe cardiovascular disease;
  • atony of the urinary system;
  • renal and hepatic insufficiency;
  • hyperplasia of the reproductive organs.

Pregnant and breastfeeding women should only take Prozac if the benefits far outweigh the expected risks. For people over the age of 65, treatment should be carried out under the close supervision of a physician with constant monitoring of vital signs.

Ways to Minimize the Side Effects of Prozac

Experts provide some actionable advice. They will help to avoid unwanted manifestations after taking fluoxetine or cope with them if it was not possible to protect yourself from this:

  1. You should ask your doctor in detail about possible unpleasant manifestations even before starting the treatment course.
  2. Find out what reactions you should expect based on your individual indicators and the clinical picture of the disease.
  3. Ask if home remedies are available to manage the effects of therapy.
  4. Report the slightest deviation of health to your doctor.
  5. Do not change the regimen of the drug and its dosage without consulting a doctor.
  6. If your condition worsens, call 911 if you can't get to the clinic.
  7. Do not ignore the appointments of a specialist and, if necessary, undergo a course of treatment in a hospital.

In some situations, detoxification of the body and symptomatic drug therapy will be required to overcome the side effects of Prozac. The main thing to remember: in case of undesirable manifestations - do not take any steps without consulting a doctor.

Literature:

  1. Vinogradova IA Pharmacology of antidepressants: textbook. - Petrozavodsk: PetrGU Publishing House, 2020. - 36 p.
  2. Sprints AM Psychotic and neurotic disorders in patients with somatic pathology: a guide for physicians. - St. Petersburg: SpecLit, 2007. - 252 p.
  3. Rachin AP Depressive and anxiety states. - Moscow: GEOTAR-Media, 2010. - 103 p.
  4. Kokin I. V. Pharmacokinetics and clinical efficacy of domestic drugs Amitriptyline and Fluoxetine: Candidate of Medical Sciences thesis (Place of defense: Moscow Medical Academy).
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