Amoxapine Side Effects

Please note - some side effects for Amoxapine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Amoxapine - for the Consumer

Amoxapine

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 Amoxapine:

Anxiety; changes in appetite; changes in blood pressure; clumsiness; confusion; constipation; dizziness; drowsiness; dry mouth; excitement; headache; increased sweating; nausea; nervousness; nightmares; pounding in the chest; restlessness; sleeplessness; swelling; tiredness; tremors; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Amoxapine:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever with increased sweating; impotence; lip smacking or puckering; seizures; severe muscle stiffness; uncontrolled chewing movements; uncontrolled movements of hands, arms, or legs; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Amoxapine Side Effects - for the Professional

Amoxapine

Adverse reactions reported in controlled studies in the United States are categorized with respect to incidence below. Following this is a listing of reactions known to occur with other antidepressant drugs of this class.

Incidence Greater Than 1%

The most frequent types of adverse reactions occurring with Amoxapine in controlled clinical trials were sedative and anticholinergic: these included drowsiness (14%), dry mouth (14%), constipation (12%), and blurred vision (7%).

Less frequently reported reactions are:

CNS and Neuromuscular: anxiety, insomnia, restlessness, nervousness, palpitations, tremors, confusion, excitement, nightmares, ataxia, alterations in EEG patterns.

Allergic: edema, skin rash.

Endocrine: elevation of prolactin levels.

Gastrointestinal: nausea.

Other: dizziness, headache, fatigue, weakness, excessive appetite, increased perspiration.

Incidence Less Than 1%

Anticholinergic: disturbances of accommodation, mydriasis, delayed micturition, urinary retention, nasal stuffiness.

Cardiovascular: hypotension, hypertension, syncope, tachycardia.

Allergic: drug fever, urticaria, photosensitization, pruritus, vasculitis, hepatitis.

CNS and Neuromuscular: tingling, paresthesias of the extremities, tinnitus, disorientation, seizures, hypomania, numbness, incoordination, disturbed concentration, hyperthermia, extrapyramidal symptoms, including, tardive dyskinesia. Neuroleptic malignant syndrome has been reported.

Hematologic: leukopenia, agranulocytosis.

Gastrointestinal: epigastric distress, vomiting, flatulence, abdominal pain, peculiar taste, diarrhea.

Endocrine: increased or decreased libido, impotence, menstrual irregularity, breast enlargement and galactorrhea in the female, syndrome of inappropriate antidiuretic hormone secretion.

Other: lacrimation, weight gain or loss, altered liver function, painful ejaculation.

Drug Relationship Unknown

The following reactions have been reported rarely, and occurred under uncontrolled circumstances where a drug relationship was difficult to assess. These observations are listed to serve as alerting information to physicians.

Anticholinergic: paralytic ileus.

Cardiovascular: atrial arrhythmias (including atrial fibrillation), myocardial infarction, stroke, heart block.

CNS and Neuromuscular: hallucinations.

Hematologic: thrombocytopenia, eosinophilia, purpura, petechiae.

Gastrointestinal: parotid swelling.

Endocrine: change in blood glucose levels.

Other: pancreatitis, hepatitis, jaundice, urinary frequency, testicular swelling, anorexia, alopecia.

Additional Adverse Reactions

The following reactions have been reported with other antidepressant drugs.

Anticholinergic: sublingual adenitis, dilation of the urinary tract.

CNS and Neuromuscular: delusions.

Gastrointestinal: stomatitis, black tongue.

Endocrine: gynecomastia.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have included drowsiness (14%), anxiety, dizziness, headache, fatigue, weakness, insomnia, sleep abnormalities, restlessness, nervousness, tremors, confusion, excitement, nightmares, and alterations in the EEG patterns.

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.

Gastrointestinal

Gastrointestinal side effects have included dry mouth (14%), constipation (12%), nausea, and excessive appetite.

Ocular

Ocular side effects have included blurred vision (7%).

Cardiovascular

Cardiovascular side effects have included palpitations.

Musculoskeletal

Musculoskeletal side effects have included ataxia.

Hypersensitivity

Hypersensitivity side effects have included edema.

Dermatologic

Dermatologic side effects have included excessive perspiration and skin rash.

Endocrine

Endocrine side effects have included elevation of prolactin levels and hyponatremia (in association with the syndrome of inappropriate secretion of antidiuretic hormone).

A retrospective register study of the World Health Organization (WHO) database for spontaneous reporting of adverse drug reactions (n=668) suggests that the risk of hyponatremia during treatment with antidepressants seems to be highest in women, in the elderly, during the summer season, and during the first weeks of therapy.

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