Duloxetine Side Effects

Some side effects of duloxetine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to duloxetine: capsule delayed rel pellets oral, oral delayed release capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking duloxetine: 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:

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• feeling like you might pass out;

• agitation, hallucinations, fever, fast heart rate, overactive reflexes, vomiting, diarrhea, loss of coordination;

• very stiff (rigid) muscles, high fever, sweating, confusion, tremors;

• easy bruising, unusual bleeding;

• painful or difficult urination;

• headache, trouble concentrating, memory problems, weakness, feeling unsteady, seizure, shallow breathing or breathing that stops; 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.

Other common side effects may include:

• dry mouth;

• drowsiness;

• tired feeling;

• mild nausea or loss of appetite; or

• constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to duloxetine: oral delayed release capsule

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 have included 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. Hallucinations 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. Trismus has also been reported.

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

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

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.

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. Serious skin reactions including Stevens-Johnson Syndrome that have required drug discontinuation and/or hospitalization have been reported with duloxetine. Erythema multiforme and urticaria have also been reported.

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. gynecological bleeding

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

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. A case of hypomania has also been reported.

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.

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. Hypertensive crisis and supraventricular arrhythmia have 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

Metabolic side effects have infrequently included hyponatremia.

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.

Immunologic

Immunologic side effects including seasonal allergy have been reported.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic reaction, angioneurotic edema, and hypersensitivity.

Endocrine

Endocrine side effects have included galactorrhea, hyperglycemia, and hyperprolactinemia.

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