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Cymbalta (duloxetine) is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Duloxetine affects chemicals in the brain that may be unbalanced in people with depression.
Cymbalta is used to treat major depressive disorder in adults. It is also used to treat general anxiety disorder in adults and children who are at least 7 years old.
Cymbalta is also used in adults to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain).
Cymbalta is also used to treat pain caused by nerve damage in adults with diabetes (diabetic neuropathy).
Do not take Cymbalta within 5 days before or 14 days after you have used a MAO inhibitor, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine, or methylene blue injection.
Cymbalta should not be used if you have narrow angle glaucoma.
Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Do not stop using Cymbalta without first talking to your doctor.
You should not use Cymbalta if you are allergic to duloxetine.
Do not take Cymbalta within 5 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine, or methylene blue injection. A dangerous drug interaction could occur.
Some medicines can interact with duloxetine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.
To make sure Cymbalta is safe for you, tell your doctor if you have ever had:
liver or kidney disease;
seizures or epilepsy;
a bleeding or blood clotting disorder;
high blood pressure;
narrow-angle glaucoma;
diabetes;
difficulty urinating;
bipolar disorder (manic depression);
drug addiction or suicidal thoughts.
Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using Cymbalta. Your family or other caregivers should also be alert to changes in your mood or symptoms.
It is not known whether duloxetine will harm an unborn baby. However, Cymbalta may cause problems in a newborn if you take the medicine during the third trimester of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Cymbalta on the baby.
Duloxetine can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.
Take Cymbalta exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take Cymbalta with or without food.
Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.
It may take 1 to 4 weeks before your symptoms improve. Keep using the medication as directed. Do not stop using Cymbalta without first talking to your doctor. You may have unpleasant side effects if you stop taking this medicine suddenly.
Store Cymbalta at room temperature away from moisture and heat.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid drinking alcohol. It may increase your risk of liver damage.
Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with Cymbalta may cause you to bruise or bleed easily.
Cymbalta may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Severe dizziness or fainting can cause falls, accidents, or severe injuries.
Get emergency medical help if you have signs of an allergic reaction to Cymbalta: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
a light-headed feeling, like you might pass out;
vision changes, eye pain or swelling, eye redness;
easy bruising, unusual bleeding;
painful or difficult urination;
a seizure;
a manic episode - racing thoughts, increased energy, reckless behavior, feeling extremely happy or irritable, talking more than usual, severe problems with sleep;
right-sided upper stomach pain, itching, dark urine, yellowing of the skin or eyes (signs of liver problems);
headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady (signs of low levels of sodium in the body); or
severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Older adults may be more sensitive to the side effects of this medicine.
Common Cymbalta side effects may include:
dry mouth;
drowsiness, dizziness;
tired feeling;
nausea, constipation, loss of appetite, weight loss; or
increased sweating.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Many drugs can interact with duloxetine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
any other antidepressant;
cimetidine;
St. John's wort;
theophylline;
tryptophan (sometimes called L-tryptophan);
an amphetamine - Adderall, Focalin, Vyvanse, Ritalin, Concerta, Strattera, and others;
an antibiotic - ciprofloxacin, enoxacin;
a blood thinner - warfarin, Coumadin, Jantoven;
heart rhythm medication - flecainide, propafenone, quinidine, and others;
opioid medicine - fentanyl, tramadol;
medicine to treat mood disorders, thought disorders, or mental illness - buspirone, lithium, thioridazine, and many others; or
migraine headache medicine - sumatriptan, rizatriptan, zolmitriptan, and others.
This list is not complete and many other drugs can interact with duloxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Cymbalta only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Cymbalta (www.drugs.com/cymbalta.html).
Note: This document contains side effect information about duloxetine. Some of the dosage forms listed on this page may not apply to the brand name Cymbalta.
Common side effects of Cymbalta include: asthenia, constipation, diarrhea, dizziness, drowsiness, fatigue, hypersomnia, insomnia, nausea, sedated state, headache, and xerostomia. Other side effects include: agitation, erectile dysfunction, nervousness, psychomotor agitation, tension, vomiting, abdominal pain, anorexia, decreased appetite, decreased libido, hyperhidrosis, loss of libido, and restlessness. See below for a comprehensive list of adverse effects.
Applies to duloxetine: oral capsule delayed release
Oral route (Capsule, Delayed Release)
Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder. Short-term studies did not show an increase in the risk of suicidality with antidepressants in adults beyond age 24, and there was a reduction in risk with antidepressants in adults aged 65 or older. Closely monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers to closely observe the patient and communicate with the prescriber.
Along with its needed effects, duloxetine (the active ingredient contained in Cymbalta) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking duloxetine:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking duloxetine:
Symptoms of overdose
Some side effects of duloxetine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Applies to duloxetine: oral delayed release capsule
The most commonly reported side effects reported in placebo-controlled clinical trials included nausea, dry mouth, somnolence, constipation, decreased appetite, hyperhidrosis, agitation, fatigue, insomnia, dizziness
The most commonly reported side effects reported in placebo-controlled clinical trials as a reason for treatment discontinuation and considered to be drug-related included nausea, dizziness, somnolence, headache, and fatigue.
Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between the use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding.
Very common (10% or more): Constipation, diarrhea, dry mouth, nausea
Common (1% to 10%): Abdominal pain, dyspepsia, flatulence, vomiting
Uncommon (0.1% to 1%): Dysphagia, eructation, gastritis, gastroenteritis, gastrointestinal hemorrhage, halitosis, hematochezia, stomatitis
Rare (less than 0.1%): Gastric ulcer
Postmarketing reports: Gastrointestinal bleeding, pancreatitis, colitis (microscopic or unspecified)
Very common (10% or more): Dizziness, headache, somnolence
Common (1% to 10%): Dysgeusia, lethargy, paraesthesia/hypoesthesia, tremor
Uncommon (0.1% to 1%): Convulsions, disturbance in attention, dyskinesia, extrapyramidal symptoms, myoclonus, psychomotor restlessness, restless legs syndrome, trismus, syncope
Rare (less than 0.1%): Akathisia, dysarthria, gait disturbance
Postmarketing reports: Intracerebral bleeding, seizures upon treatment discontinuation, serotonin syndrome, extrapyramidal disorder
Potentially life-threatening serotonin syndrome has been reported with SSRIs and SNRIs, including duloxetine as monotherapy, but particularly with concomitant use of other serotonergic drugs and drugs that impair the metabolism of serotonin.
Antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. An increased risk of suicidal thinking and behavior in children, adolescents, and young adults (aged 18 to 24 years) with major depressive disorder (MDD) and other psychiatric disorders has been reported with short-term use of antidepressant drugs.
Adult and pediatric patients receiving antidepressants for MDD, as well as for psychiatric and nonpsychiatric indications, have reported symptoms that may be precursors to emerging suicidality, including anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Causality has not been established.
Aggression and anger have been reported particularly early in treatment or after treatment discontinuation.
Very common (10% or more): Insomnia
Common (1% to 10%): Abnormal dreams, agitation, anxiety, sleep disorder
Uncommon (0.1% to 1%): Apathy, bruxism, disorientation/confusional state, irritability, mood swings, nervousness, poor quality sleep, suicide attempt
Rare (less than 0.1%): Aggression and anger, completed suicide, hallucinations, mania, suicidal behavior and ideation
Common (1% to 10%): Decreased appetite, weight increase/decrease
Uncommon (0.1% to 1%): Dehydration, hyperlipidemia, hyponatremia, increased blood cholesterol, increased blood creatine phosphokinase
Rare (less than 0.1%): Dyslipidemia, increased blood potassium
Frequency not reported: Abnormal potassium levels, increased bicarbonate
Postmarketing reports: Hyperglycemia
Although infrequent, several cases of duloxetine induced hyponatremia have been reported. In one case report, duloxetine induced hyponatremia was confirmed after inadvertent rechallenge. It has been suggested that there is a dose-related effect in the development of hyponatremia with duloxetine. Numerous cases of hyponatremia have been reported following treatment with an SSRI. Risk factors include advanced age, female gender, concomitant use of diuretics, low body weight, and lower baseline serum sodium levels.
Hyponatremia tends to develop within the first few weeks of treatment (range 3 to 120 days) and typically resolves within 2 weeks (range 48 hours to 6 weeks) after therapy has been discontinued with some patients requiring treatment (e.g., water restriction, dietary sodium). The proposed mechanism for the development of hyponatremia involves the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) via release of antidiuretic hormone.
Falls were reported more commonly in patients 65 years of age or older.
Very common (10% or more): Fatigue
Common (1% to 10%): Asthenia, chills/rigors, pyrexia, vertigo
Uncommon (0.1% to 1%): Ear pain, falls, feeling abnormal, feeling hot and/or cold, malaise, thirst, tinnitus
Orthostatic hypotension and syncope tend to occur within the first week of therapy; however, they may occur at any time during treatment, particularly after dose increases. The risk of blood pressure decreases may be greater when duloxetine (the active ingredient contained in Cymbalta) is given concomitantly with drugs that may induce orthostatic hypotension, such as antihypertensives, with potent CYP450 1A2 inhibitors, or with duloxetine doses above 60 mg per day.
Common (1% to 10%): Flushing, hot flush, hypertension, increased blood pressure, palpitations
Uncommon (0.1% to 1%): Chest pain, myocardial infarction, orthostatic hypotension, peripheral coldness, tachycardia
Rare (less than 0.1%): Hypertensive crisis, supraventricular arrhythmia (mainly atrial fibrillation)
Postmarketing reports: Hematomas, ventricular arrhythmias
The reporting rate of Stevens-Johnson syndrome associated with duloxetine (the active ingredient contained in Cymbalta) exceeds the general population background incidence rate (1 to 2 cases per million person years).
Common (1% to 10%): Pruritus, hyperhidrosis
Uncommon (0.1% to 1%): Cold sweat, contact dermatitis, erythema, increased tendency to bruise, night sweats, photosensitivity reaction, urticaria
Rare (less than 0.1%): Angioneurotic edema, ecchymosis, Stevens-Johnson syndrome
Postmarketing reports: Erythema multiforme, petechiae, cutaneous vasculitis (sometimes with systemic involvement)
Uncommon (0.1% to 1%): Hypothyroidism, syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
Postmarketing reports: Hyperprolactinemia
The Arizona sexual experience scale, used to identify sexual side effects, was used prospectively in 4 major depressive disorder placebo-controlled trials showed that male patients treated with duloxetine (the active ingredient contained in Cymbalta) experienced significantly more sexual dysfunction than patients treated with placebo.
Common (1% to 10%): Abnormal orgasm/anorgasmia, decreased libido, delayed ejaculation, ejaculation disorder, erectile dysfunction, urinary frequency
Uncommon (0.1% to 1%): Abnormal urine odor, dysuria, gynecological hemorrhage, menopausal symptoms, micturition urgency, nocturia, pollakiuria, polyuria, sexual dysfunction, testicular pain, urinary hesitation
Rare (less than 0.1%): Decreased urine flow, galactorrhea, menstrual disorder, urinary retention
Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may increase the risk of bleeding events associated with duloxetine (the active ingredient contained in Cymbalta)
Postmarketing reports: Life-threatening hemorrhage, blood dyscrasias
Cases of liver failure, including fatalities, have been reported. The majority of cases were reported in patients with past or current risk factors for liver injury, including alcohol abuse, hepatitis, or exposure to drugs with known adverse effects on the liver.
Uncommon (0.1% to 1%): Acute liver injury, elevated liver enzymes (ALT, AST, GGT, alkaline phosphatase), hepatitis, increased blood bilirubin
Rare (less than 0.1%): Hepatic failure, jaundice
Postmarketing reports: Anaphylactic reaction, hypersensitivity
Common (1% to 10%): Influenza
Common (1% to 10%): Back pain, muscle spasms, musculoskeletal pain (including myalgia, neck pain)
Uncommon (0.1% to 1%): Muscle tightness (including musculoskeletal stiffness), muscle twitching
Postmarketing reports: Rhabdomyolysis
Pupillary dilation that occurs following the use of many antidepressant drugs may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Diplopia, dry eye, mydriasis, visual impairment
Rare (less than 0.1%): Glaucoma
Postmarketing reports: Renal impairment
Common (1% to 10%): Cough, nasopharyngitis, oropharyngeal pain, pharyngolaryngeal pain, upper respiratory tract infection, yawning
Uncommon (0.1% to 1%): Laryngitis, throat tightness
Rare (less than 0.1%): Epistaxis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Cymbalta (www.drugs.com/cymbalta.html).
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