ADVERSE REACTIONS
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. (See
WARNINGS
.)
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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