Cymbalta 30mg side effects

Side effects of duloxetine - NHS

Like all medicines, duloxetine can cause side effects in some people. But most people have no side effects or only minor ones.

Some of the common side effects of duloxetine will gradually improve as your body gets used to it.

Common side effects

These common side effects of duloxetine can happen in up to 1 in 10 people. There are things you can do to help cope with them:

Difficulty sleeping

Try taking duloxetine first thing in the morning.

Headaches

Make sure you rest and drink plenty of fluids. Try not to drink too much alcohol. Ask your pharmacist to recommend a painkiller. Talk to your doctor if the headaches last longer than a week or are severe.

Feeling dizzy

If duloxetine makes you feel dizzy when you stand up, try getting up very slowly or stay sitting down until you feel better. If you begin to feel dizzy, lie down so you do not faint, then sit until you feel better. Do not drive, cycle or use tools or machinery if you feel dizzy.

Blurred vision

Avoid driving, cycling or using tools or machinery while this is happening. If it lasts for more than a day or two, your doctor may need to change your treatment.

Constipation

Try to get more fibre into your diet, such as fresh fruit and vegetables and cereals, and drink plenty of water. Try to exercise more regularly, for example by going for a daily walk or run.

Diarrhoea

Drink lots of fluids, such as water or squash, to avoid dehydration. Signs of dehydration include peeing less than usual or having dark, strong-smelling pee.

Do not take any other medicines to treat diarrhoea without speaking to a pharmacist or doctor.

If you take contraceptive pills and you have severe diarrhoea for more than 24 hours, your contraception may not protect you from pregnancy. Check the pill packet for advice.

Feeling or being sick (nausea or vomiting)

Stick to simple meals and do not eat rich or spicy food. Make sure you take duloxetine in the morning with some food. Try small, frequent sips of water if you're being sick to avoid dehydration. Signs of dehydration include peeing less than usual or having dark, strong-smelling pee.

If you take contraceptive pills and you're being sick, your contraception may not protect you from pregnancy. Check the pill packet for advice.

Dry mouth

Chew sugar-free gum or suck sugar-free sweets.

Sweating

Try wearing loose clothing, use a strong anti-perspirant, and keep cool using a fan if possible. If this does not help, you may need to try a different type of antidepressant.

Tiredness

Do not drive, cycle or use tools or machinery if you're feeling this way. Try taking duloxetine 1 hour before bedtime. Cut down the amount of alcohol you drink as alcohol will make you feel more tired.

If the tiredness does not go away after 2 weeks, ask your doctor for advice.

Less appetite than usual and weight loss

This side effect should get better as your body gets used to the medicine. It may also help to eat smaller meals more often and eat foods you really enjoy. If your appetite does not improve or you lose a lot of weight, ask your doctor for advice.

Feeling less interested in sex, or having problems keeping an erection or reaching orgasm

Speak to your doctor if you get this side effect and it does not go away.

Speak to a doctor or pharmacist if the advice on how to cope does not help and a side effect is still bothering you or does not go away.

Serious side effects

Serious side effects are rare and happen in less than 1 in 100 people.

Book an appointment with your doctor if you get changes in your periods, such as heavy bleeding, spotting or bleeding between periods.

Call a doctor or contact 111 straight away if you have:

hallucinations (seeing or hearing things that are not real), or you become aggressive and angry
feelings of euphoria, excessive enthusiasm or excitement, or feeling restless so that you cannot sit or stand still
constant headaches, long-lasting confusion or weakness, or frequent muscle cramps – these can be signs of low sodium levels in your blood
yellowing of the whites of your eyes, or your skin although this may be less obvious on brown or black skin – these can be signs of a liver problem
eye pain or blurred vision
black or red poo or blood in your vomit – these can be signs of bleeding from your gut
coughed up blood or have blood in your pee
bleeding from your gums, or bruises that appear without a reason or get bigger

Go to 111. nhs.uk or call 111.

Immediate action required: Call 999 or go to A&E now if you get:

tightness in your chest or shortness of breath
any heavy bleeding that you cannot stop, such as cuts or nosebleeds that do not stop within 10 to 15 minutes
painful erections that last longer than 2 hours – this may happen even when you're not having sex
thoughts about harming yourself or ending your life

Find your nearest A&E

Serious allergic reaction

In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to duloxetine.

Immediate action required: Call 999 or go to A&E now if:

you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
you're wheezing
you get tightness in the chest or throat
you have trouble breathing or talking
your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

Other side effects

These are not all the side effects of duloxetine. For a full list, see the leaflet inside your medicines packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

Page last reviewed: 14 February 2022
Next review due: 14 February 2025

Duloxetine (Cymbalta) | NAMI: National Alliance on Mental Illness

Brand names:

Cymbalta®
- Capsules (delayed release): 20 mg, 30 mg, 60 mg
Drizalma Sprinkle™
- Capsules (delayed release sprinkle): 20 mg, 30 mg, 40 mg, 60mg
Duloxetine
- Capsules (delayed release): 20 mg, 30 mg, 40 mg, 60 mg

Generic name: Duloxetine (doo LOX e teen)

All FDA black box warnings are at the end of this fact sheet. Please review before taking this medication.

What Is Duloxetine And What Does It Treat?

Duloxetine is an antidepressant medication that works in the brain. It is approved for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), fibromyalgia, and chronic musculoskeletal pain.

Symptoms of depression include:

Depressed mood - feeling sad, empty, or tearful
Feeling worthless, guilty, hopeless, and helpless
Loss of interest or pleasure in your usual activities
Sleep and eat more or less than usual (for most people it is less)
Low energy, trouble concentrating, or thoughts of death (suicidal thinking)
Psychomotor agitation (‘nervous energy’)
Psychomotor retardation (feeling like you are moving and thinking in slow motion)
Suicidal thoughts or behaviors

Generalized Anxiety Disorder (GAD) occurs when a person experiences excessive anxiety or worry for at least six months. Other symptoms include:

Restlessness
Fatigue (low energy, feeling tired all the time)
Difficulty concentrating
Irritability
Muscle tension
Sleep disturbance (difficulty falling asleep or waking up in the middle of the night)

What Is The Most Important Information I Should Know About Duloxetine?

Do not stop taking duloxetine, even when you feel better. With input from you, your health care provider will assess how long you will need to take the medicine.

Missing doses of duloxetine may increase your risk for relapse in your symptoms.

Stopping duloxetine abruptly may result in one or more of the following withdrawal symptoms: irritability, nausea, feeling dizzy, vomiting, nightmares, headache, and/or paresthesias (prickling, tingling sensation on the skin).

Depression is also a part of bipolar illness. People with bipolar disorder who take antidepressants may be at risk for "switching" from depression into mania. Symptoms of mania include "high" or irritable mood, very high self-esteem, decreased need for sleep, pressure to keep talking, racing thoughts, being easily distracted, frequently involved in activities with a large risk for bad consequences (for example, excessive buying sprees).

Medical attention should be sought if serotonin syndrome is suspected. Please refer to serious side effects for signs/symptoms.

Are There Specific Concerns About Duloxetine And Pregnancy?

If you are planning on becoming pregnant, notify your health care provider to best manage your medications. People living with MDD who wish to become pregnant face important decisions. Untreated MDD has risks to the fetus, as well as the mother. It is important to discuss the risks and benefits of treatment with your doctor and caregivers. For women who take antidepressant medications during weeks 13 through the end of their pregnancy (second and third trimesters), there is a risk that the baby can be born before it is fully developed (before 37 weeks).

Caution is advised with breastfeeding since duloxetine does pass into breast milk.

What Should I Discuss With My Health Care Provider Before Taking Duloxetine?

Symptoms of your condition that bother you the most
If you have thoughts of suicide or harming yourself
Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects

If you experience side effects from your medications, discuss them with your provider. Some side effects may pass with time, but others may require changes to the medication.
Any other psychiatric or medical problems you have, including a history of bipolar disorder, kidney or liver disease
All other medications you are currently taking (including over the counter products, herbal and nutritional supplements) and any medication allergies you have
Other non-medication treatment you are receiving, such as talk therapy or substance abuse treatment. Your provider can explain how these different treatments work with the medication.
If you are pregnant, plan to become pregnant, or are breastfeeding
If you drink alcohol or use drugs

How Should I Take Duloxetine?

Duloxetine is usually taken 1 or 2 times per day with or without food.

Typically, patients begin at a low dose of medicine and the dose is increased slowly over several weeks.

The dose usually ranges from 20 mg to 120 mg. Only your health care provider can determine the correct dose for you.

The capsule should be swallowed whole. It should not be chewed, crushed, or broken.

The duloxetine delayed release capsule (Cymbalta® or generic duloxetine) should be swallowed whole. It should not be chewed, crushed, or broken. Drizalma Sprinkle™ delayed release capsules may be opened and sprinkled on applesauce, if needed.

Consider using a calendar, pillbox, alarm clock, or cell phone alert to help you remember to take your medication. You may also ask a family member or a friend to remind you or check in with you to be sure you are taking your medication.

What Happens If I Miss A Dose Of Duloxetine?

If you miss a dose of duloxetine take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your health care provider. Do not double your next dose or take more than what is prescribed.

What Should I Avoid While Taking Duloxetine?

Avoid drinking alcohol or using illegal drugs while you are taking antidepressant medications. They may decrease the benefits (e.g., worsen your condition) and increase adverse effects (e.g., sedation) of the medication. Alcohol increases the risk of liver problems with duloxetine.

What Happens If I Overdose With Duloxetine?

If an overdose occurs, call your doctor or 911. You may need urgent medical care. You may also contact the poison control center at 1-800-222-1222.

A specific treatment to reverse the effects of duloxetine does not exist.

What Are Possible Side Effects Of Duloxetine?

Common side effects

Headache, nausea, diarrhea, dry mouth, decreased appetite, increased sweating, feeling nervous, restless, fatigued, sleepy or having trouble sleeping (insomnia). These will often improve over the first week or two as you continue to take the medication.

Sexual side effects, such as problems with orgasm or ejaculatory delay, and blood pressure increases often do not improve over time.

Rare/serious side effects

There have been rare reports of liver failure (sometimes fatal) with duloxetine. This risk is increased in those with substantial alcohol use or chronic liver disease.

Orthostatic hypotension, or a drop in blood pressure when standing or getting up from sleeping, has been reported in patients taking duloxetine. The risk may be greater in patients also taking medications for high blood pressure.

Increased heart rate, irregular menstrual cycle, increased frequency of urination or difficulty urinating, increased liver enzymes, teeth grinding, low sodium (symptoms of low sodium levels may include headache, weakness, difficulty concentrating and remembering), angle closure glaucoma (symptoms of angle closure glaucoma may include eye pain, changes in vision, swelling or redness in or around eye), serotonin syndrome (symptoms may include shivering, diarrhea, confusion, severe muscle tightness, fever, seizures, and death), hypertensive crisis (severely elevated blood pressure), myocardial infarction (heart attack), Stevens-Johnson Syndrome (rash), pancreatitis

SNRI antidepressants, including duloxetine, may increase the risk of bleeding events. Combined use of aspirin, nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen), warfarin, and other anti-coagulants may increase this risk. This may include gums that bleed more easily, nose bleed, or gastrointestinal bleeding. Some cases have been life threatening.

Are There Any Risks For Taking Duloxetine For Long Periods Of Time?

To date, there are no known problems associated with long term use of duloxetine. It is a safe and effective medication when used as directed.

What Other Medications May Interact With Duloxetine?

Duloxetine should not be taken with or within 2 weeks of taking monoamine oxidase inhibitors (MAOIs). These include phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), rasagiline (Azalect®) and selegiline (Emsam®).

Although rare, there is an increased risk of serotonin syndrome when duloxetine is used with other medications that increase serotonin, such as other antidepressants, migraine medications called “triptans” (e. g., Imitrex®), some pain medications (e.g., tramadol (Ultram®), the antibiotic linezolid (Zyvox®), and amphetamines.

The following medications may increase the levels and effects of duloxetine: cimetidine (Tagamet®), ciprofloxacin (Cipro®), fluoxetine (Prozac®), fluvoxamine (Luvox®), paroxetine (Paxil®)

Duloxetine may increase the effects of other medications that can cause bleeding (e.g., ibuprofen (Advil®, Motrin®), warfarin (Coumadin®) and aspirin).

How Long Does It Take For Duloxetine To Work?

Sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working. Depressed mood and lack of interest in activities may need up to 6-8 weeks to fully improve.

Summary of FDA Black Box Warnings

Suicidal thoughts or actions in children and adults

Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications. This risk may persist until significant remission occurs.

In short-term studies, antidepressants increased the risk of suicidality in children, adolescents, and young adults when compared to placebo. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24. Adults age 65 and older taking antidepressants have a decreased risk of suicidality. Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or health care professional. All patients being treated with antidepressants for any indication should watch for and notify their health care provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.

Provided by

(December 2020)

©2020 The College of Psychiatric and Neurologic Pharmacists (CPNP) and the National Alliance on Mental Illness (NAMI). CPNP and NAMI make this document available under the Creative Commons Attribution-No Derivatives 4.0 International License. Last Updated: January 2016.

This information is being provided as a community outreach effort of the College of Psychiatric and Neurologic Pharmacists. This information is for educational and informational purposes only and is not medical advice. This information contains a summary of important points and is not an exhaustive review of information about the medication. Always seek the advice of a physician or other qualified medical professional with any questions you may have regarding medications or medical conditions. Never delay seeking professional medical advice or disregard medical professional advice as a result of any information provided herein. The College of Psychiatric and Neurologic Pharmacists disclaims any and all liability alleged as a result of the information provided herein.

Duloxetine for the treatment of painful neuropathy, chronic pain or fibromyalgia

Review question

Does duloxetine work to treat pain generated by nerves when damaged by disease or pain caused by fibromyalgia?

Relevance

Duloxetine is a medicine used to treat depression and urinary incontinence (urinary leakage), and may also be useful for certain types of pain. Pain can occur spontaneously when there is damage to the nerves that carry pain information to the brain (neuropathic pain). When nerve damage occurs outside of the spinal cord, it is called peripheral neuropathy. Another type of pain, nociceptive pain, occurs when nerves sense damage to another tissue (such as a prick in the skin). Some types of pain of unknown origin occur without visible nerve or tissue damage. This type of pain occurs, for example, with fibromyalgia. The purpose of this review was to evaluate the benefits and harms of duloxetine for the treatment of neuropathic pain and chronic pain of all types.

Study profile

We reviewed all published scientific literature and found 18 trials with a total of 6407 participants that were of sufficient quality to include in this review. Eight clinical trials examined the effect of duloxetine in painful diabetic neuropathy and six in pain associated with fibromyalgia. Three trials looked at painful physical symptoms associated with depression, and one small study looked at duloxetine for stroke pain or spinal cord disease (central pain).

Main findings and quality of evidence

The usual dose of duloxetine is 60 mg. There was moderate-quality evidence that duloxetine at this dose reduced pain in painful diabetic peripheral neuropathy and fibromyalgia. In diabetic peripheral neuropathic pain, 50% or slightly more had an improvement on duloxetine 60 mg per day more than one and a half times more often than in the placebo group. In other words, five people with diabetic peripheral neuropathy must receive duloxetine in order for one of them to achieve an effect of 50% or more. The effect on fibromyalgia was similar, but the number of patients needed to be treated for improvement of 50% or more was eight. Based on only one study, it is not possible to determine whether the 20 mg dose is effective, and the 120 mg dose was no more effective than 60 mg.

We calculated that there were sufficient trials for diabetic neuropathy to draw these conclusions and no further trials are required. For fibromyalgia and the painful symptoms associated with depression, more trials are needed to make strong claims about the effectiveness of duloxetine.

Most people who take duloxetine will have at least one side effect. They are mostly minor and the most common are feeling unwell, insomnia or drowsiness, headache, dry mouth, constipation or dizziness. About one in six people will stop taking duloxetine due to side effects. Serious problems associated with duloxetine are very rare.

Although duloxetine is useful in the treatment of neuropathic pain and fibromyalgia, there is little evidence from clinical trials comparing duloxetine with other antidepressants as to which is better.

We conclude that duloxetine can be used to treat pain associated with diabetic neuropathy and possibly fibromyalgia.

The information contained in this review is current up to November 2013, when the most recent literature search was made.

Translation notes:

Translation notes: Translation: Alexandrova Elvira Grigorievna. Editing: Gamirova Rimma Gabdulbarovna, Ziganshina Lilia Evgenievna. Russian translation project coordination: Kazan Federal University. For questions related to this transfer, please contact us at: [email protected]

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