Cymbalta Side Effects

Please note - some side effects for Cymbalta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Cymbalta - for the Consumer

Cymbalta Delayed-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cymbalta Delayed-Release Capsules:

Constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; loss of appetite; nausea; sore throat; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bizarre behavior; bloody or black, tarry stools; blurred vision; confusion; dark urine; decreased concentration; decreased coordination; excessive sweating; fainting; fast or irregular heartbeat; fever or chills; hallucinations; memory loss; new or worsening aggressiveness, agitation, anxiety, hostility, impulsiveness, irritability, panic attacks, restlessness, or inability to sit still; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, or diarrhea; severe or persistent tiredness or weakness; severe or persistent trouble sleeping; stiff muscles; stomach pain; suicidal thoughts or attempts; tremor; trouble urinating or change in the amount of urine produced; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vomit that looks like coffee grounds; worsening of depression; yellowing of the skin or eyes.

Cymbalta Side Effects - for the Professional

Cymbalta

• Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): nausea, dry mouth, constipation, somnolence, hyperhidrosis, and decreased appetite (6.3).

To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects including nausea (14% to 30%), dry mouth (5% to 15%), constipation (5% to 18%), diarrhea (7% to 13%), vomiting (5% to 6%), dyspepsia (4% to 5%), loose stools (2% to 3%), and viral gastroenteritis (2%) have been reported. Gastritis has been reported frequently. Blood in the stool, colitis, dysphagia, acquired esophageal stenosis, gastric ulcer, gingivitis, irritable bowel syndrome, and lower abdominal pain have been reported infrequently.

Nausea (3.5%) was the most common adverse event reported as a reason for discontinuation and considered to be drug related in trials of patients treated for diabetic peripheral neuropathic pain. Additionally, nausea (1.4%) was the only common adverse event reported as a reason for discontinuation and considered to be drug related in trials of patients treated for major depressive disorder.

Nervous system

Nervous system side effects including somnolence (7% to 21%), dizziness (6% to 17%), headache (13% to 20%), tremor (up to 5%), paraesthesia (4%), dysgeusia (3%), restless legs syndrome, seizures, and sleep abnormalities have been reported.

Dizziness (1.6%), somnolence (1.6%), and fatigue (1.1%) were the common adverse events reported as reasons for discontinuation and considered to be drug related in trials of patients treated for diabetic peripheral neuropathic pain.

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Seizures have been reported upon treatment discontinuation.

General

General side effects including insomnia (8% to 13%), fatigue (2% to 15%), decreased appetite (3% to 11%), asthenia (2% to 8%), anorexia (3% to 5%), pyrexia (1% to 3%), gait disturbance, and excessive yawning have been reported. Initial insomnia has been reported frequently.

Respiratory

Respiratory side effects including nasopharyngitis (7% to 9%), upper respiratory tract infection (7%), pharyngolaryngeal pain (1% to 6%), and cough (3% to 5%) have been reported.

Other

In placebo controlled trials, patients treated with duloxetine for up to 9 weeks had an average weight loss of approximately 0.5 kg compared to an average weight gain of 0.2 kg in placebo treated patients.

Tinnitus has been reported upon treatment discontinuation.

Other side effects including decreased appetite (8%), hot flushes (2% to 3%), increased weight (2%), decreased weight (2%), and tinnitus have been reported.

Dermatologic

Dermatologic side effects including hyperhidrosis (6% to 8%), and increased sweating (6%) have been reported. Night sweats, pruritus, and rash have been reported frequently. Contact dermatitis, acne, alopecia, cold sweat, ecchymosis, eczema, erythema, face edema, increased tendency to bruise, cutaneous reactions, and photosensitivity reaction have been reported infrequently.

Genitourinary

Genitourinary side effects including decreased libido (6% of males and 1% of females), abnormal orgasm (4% of males and 2% of females), erectile dysfunction (up to 4%), delayed ejaculation (3%), ejaculatory dysfunction (3%), penis disorder (2%), gynecological bleeding, and sexual dysfunction have been reported.

Musculoskeletal

Musculoskeletal side effects including musculoskeletal pain (5%), muscle cramps ( 4% to 5%), muscle spasms (4%), and myalgia (1% to 4%) have been reported.

Renal

Renal side effects including pollakiuria (1% to 5%), polyuria, and urinary tract infection (3%) have been reported. Dysuria has been reported frequently. Micturition urgency, urinary hesitation, urinary incontinence, urinary retention, and decreased urine flow have been reported infrequently.

Ocular

Ocular side effects including blurred vision (up to 4%) have been reported.

Psychiatric

A meta-analysis consisting of 12 randomized placebo-controlled trials (n=2996) found no evidence of a treatment-related increase in risk of suicidal behaviors or ideation with duloxetine compared with placebo in patients with major depressive disorder.

Aggression and anger have been reported particularly early in treatment or after treatment discontinuation.

Psychiatric side effects including agitation (6%) and anxiety (3%) have been reported. Irritability, lethargy, nervousness, nightmare, restlessness, and sleep disorders have been reported frequently. Completed suicide, mania, manic switching, mood swings, pressure of speech, sluggishness, attempted suicide, aggression and anger have been reported infrequently.

Hepatic

Hepatic side effects including small mean increases from baseline to endpoint in ALT, AST, CPK, and alkaline phosphatase have been reported. (Infrequent, modest, transient, abnormal values were reported.)

Cardiovascular

Cardiovascular side effects have been reported including increases in blood pressure averaging 2 mm Hg systolic and 0.5 mm Hg diastolic, an increase in the incidence of at least on measurement of systolic blood pressure over 140 mm Hg, and an increase in heart rate of approximately 2 beats per minute. Palpitations (2%) have been reported. Peripheral edema and phlebitis have been reported infrequently. A case of tachycardia has also been reported.

Hematologic

Hematologic side effects including anemia, leukopenia, increased white blood cell count, lymphadenopathy, and thrombocytopenia have been reported infrequently.

Oncologic

Oncologic side effects have included animal tests which have reported an increased incidence of hepatocellular adenomas and carcinomas in females. (Male animals tested did not reveal any increased tumor incidence.)

Metabolic

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 a selective serotonin reuptake inhibitor (SSRI). Risk factors for the development of SSRI-associated hyponatremia including advanced age, female gender, concomitant use of diuretics, low body weight, and lower baseline serum sodium levels have been identified. 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.

Metabolic side effects have infrequently included hyponatremia.

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