Duloxetine Side Effects
Not all side effects for duloxetine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to duloxetine: oral capsule, oral capsule delayed release
Along with its needed effects, duloxetine 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
- Abdominal or stomach pain
- area rash
- blistering, peeling, or loosening of the skin
- blurred vision
- change in consciousness
- clay-colored stools
- cold sweats
- dark urine
- decreased urine output
- decreased vision
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- eye pain
- fast or irregular heartbeat
- general tiredness or weakness
- hives or welts
- hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
- increased thirst
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of consciousness
- red skin lesions, often with a purple center
- red, irritated eyes
- redness of the skin
- shortness of breath
- skin rash
- sores, ulcers, or white spots in the mouth or on the lips
- swelling of the face, ankles, or hands
- tightness in the chest
- unpleasant breath odor
- upper right stomach pain
- vomiting of blood
- yellow eyes and skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking duloxetine:Symptoms of overdose
- loss of bladder control
- muscle spasm or jerking of all extremities
- overactive reflexes
- poor coordination
- sleepiness or unusual drowsiness
- sudden loss of consciousness
- talking or acting with excitement you cannot control
- trembling or shaking
- unusual tiredness or weakness
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
- Body aches or pain
- difficulty having a bowel movement (stool)
- difficulty with breathing
- dry mouth
- ear congestion
- frequent urination
- lack or loss of strength
- loss of appetite
- loss of voice
- muscle aches
- sleepiness or unusual drowsiness
- sore throat
- stuffy or runny nose
- sweating increased
- trouble sleeping
- unable to sleep
- weight loss
- Abnormal orgasm
- acid or sour stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- change or problem with discharge of semen
- decreased interest in sexual intercourse
- difficulty with moving
- feeling of warmth or redness of the face, neck, arms, and occasionally, upper chest
- inability to have or keep an erection
- joint pain
- longer than usual time to ejaculation of semen
- loose stools
- loss in sexual ability, desire, drive, or performance
- loss of taste
- muscle aching or cramping
- muscle pains or stiffness
- shakiness in the legs, arms, hands, or feet
- stomach discomfort, upset, or pain
- sudden sweating
- swollen joints
- trembling or shaking of the hands or feet
For Healthcare Professionals
Applies to duloxetine: oral delayed release capsule
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 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 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 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 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 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 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 side effects including musculoskeletal pain (5%), muscle cramps ( 4% to 5%), muscle spasms (4%), and myalgia (1% to 4%) have been reported.
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 side effects including blurred vision (up to 4%) have been reported.
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 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 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 side effects including anemia, leukopenia, increased white blood cell count, lymphadenopathy, and thrombocytopenia have been reported infrequently.
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 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 side effects including seasonal allergy have been reported.
Hypersensitivity side effects have included anaphylactic reaction, angioneurotic edema, and hypersensitivity.
Endocrine side effects have included galactorrhea, hyperglycemia, and hyperprolactinemia.
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