Strattera Side Effects

Please note - some side effects for Strattera 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 Strattera - for the Consumer

Strattera

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 Strattera:

Constipation; coughing; decreased appetite; dizziness; drowsiness; dry mouth; fatigue; flushing; headache; increased sweating; mild stomach pain or upset; nausea; tiredness; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; dark urine; decreased sexual ability (eg, impotence, ejaculation problems); fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; menstrual cycle changes; mental or mood changes (eg, agitation, anxiety, depression, irritability, persistent crying, unusual sadness); new or worsening behavior changes (eg, aggression, hostility, restlessness); numbness or tingling; one-sided weakness; pale stools; persistent fatigue or tiredness; prolonged or painful erection; seizure; severe or persistent headache or dizziness; severe or persistent trouble sleeping; stomach pain or tenderness; suicidal thoughts or attempts; trouble urinating; unusual vision or speech changes; unusually cold or blue fingers or toes; yellowing of the skin or eyes.

Strattera Side Effects - for the Professional

Strattera

Most common adverse reactions (≥5% and at least twice the incidence of placebo patients)

• Child and Adolescent Clinical Trials - Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. (6.1)

• Adult Clinical Trials - Constipation, dry mouth, nausea, fatigue, decreased appetite, insomnia, erectile dysfunction, urinary hesitation and/or urinary retention and/or dysuria, dysmenorrhea, and hot flush. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

Genitourinary

Genitourinary side effects reported in adult placebo-controlled trials have included urinary hesitation and/or urinary retention and/or difficulty in micturition (8%), dysmenorrhea (7%), erectile disturbance (7%), ejaculation failure and/or ejaculation disorder (up to 5%), impotence (3%), menstrual disorder (3%), prostatitis (3%), delayed menses, irregular menstruation (2%), and abnormal orgasm (2%). Priapism, hemospermia, and male pelvic pain have been reported in postmarketing experience.

Cardiovascular

Cardiovascular side effects reported in adult placebo-controlled trials have included palpitations (up to 4%), tachycardia (3%), increased heart rate, and increased blood pressure. Orthostatic hypotension and syncope have been reported in clinical trials. New onset and exacerbation of existing Raynaud's phenomenon as well as QT prolongation have been reported in postmarketing experience.

In adult placebo-controlled trials the mean increase in heart rate was reported as 5 beats/minute and the mean increase in blood pressure was reported as 3 mm Hg systolic and 1 mm Hg diastolic.

Hepatic

Two cases of severe liver injury (a teenager and an adult) following treatment with atomoxetine for a duration of at least several months have been reported. Both patients recovered. Two additional cases of hepatitis have been reported in children (11 and 12 years of age) following treatment with atomoxetine (30 to 40 mg/day). Symptoms included jaundice, abdominal pain, fatigue, weight loss, arthralgias, diarrhea, vomiting, and elevated liver enzymes. Liver injury completely resolved in both patients following discontinuation of atomoxetine. The number of actual cases of severe liver injury is unknown because of underreporting of postmarketing adverse events.

Atomoxetine should be discontinued in patients who develop jaundice (yellowing of the skin or whites of the eyes) or have laboratory evidence of liver injury. Signs and symptoms of liver problems can include pruritus (itchy skin), jaundice, dark urine, upper right-sided abdominal tenderness, or unexplained flu-like symptoms. Health care professionals are encouraged to report any unexpected adverse events associated with atomoxetine directly to Eli Lilly at 1800-LillyRx or to the FDA MedWatch program at 1800-FDA-1088.

Hepatic side effects have included severe hepatic injury.

Gastrointestinal

Gastrointestinal side effects reported in adult placebo-controlled trials have included dry mouth (21%), nausea (up to 21%), constipation (up to 10%), abdominal pain (7%), dyspepsia (up to 6%), vomiting (3%), and flatulence (2%). One case of sialolithiasis in association with atomoxetine has been reported and confirmed upon several rechallenges.

Respiratory

Respiratory side effects reported in adult placebo-controlled trials have included sinusitis (6%).

Musculoskeletal

Musculoskeletal side effects reported in adult placebo-controlled trials have included myalgia (3%).

Nervous system

Nervous system side effects reported in adult placebo-controlled trials have included headache (17%), insomnia and/or middle insomnia (16%), dizziness (6%), paraesthesia (4%), somnolence (4%), sinus headache (3%), and tremor (2%). Seizures have been reported in 0.1% of adult patients. There have also been postmarketing reports of hypoesthesia and sensory disturbances.

Psychiatric

Psychiatric side effects reported in adult placebo-controlled trials have included insomnia (15%), decreased libido (up to 6%), abnormal dreams (4%), and sleep disorders (up to 4%). Mania has been reported rarely. Treatment emergent hostility-related effects have been reported in short-term clinical trials. Patients beginning therapy should be monitored for the appearance or worsening of aggression or hostility.

An 11-year-old male with attention deficit disorder developed mania after approximately 3 to 4 weeks of treatment with atomoxetine. The patient returned to his baseline behaviors within 7 days of discontinuing atomoxetine.

Dermatologic

Dermatologic side effects reported in adult placebo-controlled trials have included increased sweating (4%), dermatitis (2%), and rash (2%).

Hypersensitivity

Hypersensitivity side effects have rarely included angioneurotic edema, urticaria, and rash.

Ocular

Ocular side effects have included an increased risk of mydriasis.

Other

Other side effects reported in adult placebo-controlled trials have included decreased appetite (up to 11%), fatigue (up to 9%), hot flushes (up to 8%), pyrexia (3%), rigors (3%), unexpected therapeutic response (3%), chills (3%), jittery feeling (2%), and weight loss (2%).

Acute treatment studies of up to 9 weeks in duration have reported an average weight loss of 0.4 kg.

General

General side effects including lethargy have been reported.

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