ADVERSE REACTIONS
The following adverse reactions have been noted with maprotiline and are generally similar to those observed with tricyclic antidepressants.
Cardiovascular: Rare occurrences of hypotension, hypertension, tachycardia, palpitation, arrhythmia, heart block, and syncope have been reported with maprotiline.
Psychiatric: Nervousness (6%), anxiety (3%), insomnia (2%), and agitation (2%); rarely, confusional states (especially in the elderly), hallucinations, disorientation, delusions, restlessness, nightmares, hypomania, mania, exacerbation of psychosis, decrease in memory, and feelings of unreality.
Neurological: Drowsiness (16%), dizziness (8%), tremor (3%), and, rarely, numbness, tingling, motor hyperactivity, akathisia, seizures, EEG alterations, tinnitus, extrapyramidal symptoms, ataxia, and dysarthria.
Anticholinergic: Dry mouth (22%), constipation (6%), and blurred vision (4%); rarely, accommodation disturbances, mydriasis, urinary retention, and delayed micturition.
Allergic: Rare instances of skin rash, petechiae, itching, photosensitization, edema, and drug fever.
Gastrointestinal: Nausea (2%) and, rarely, vomiting, epigastric distress, diarrhea, bitter taste, abdominal cramps and dysphagia.
Endocrine: Rare instances of increased or decreased libido, impotence, and elevation or depression of blood sugar levels.
Other: Weakness and fatigue (4%) and headache (4%); rarely, altered liver function, jaundice, weight loss or gain, excessive perspiration, flushing, urinary frequency, increased salivation, nasal congestion and alopecia.
Note: Although there have been only isolated reports of the following adverse reactions with maprotiline, its pharmacologic similarity to tricyclic antidepressants requires that each reaction be considered when administering maprotiline.
— Bone marrow depression, including agranulocytosis, eosinophilia, purpura, and thrombocytopenia, myocardial infarction, stroke, peripheral neuropathy, sublingual adenitis, black tongue, stomatitis, paralytic ileus, gynecomastia in the male, breast enlargement and galactorrhea in the female, and testicular swelling.
Postintroduction Reports
Voluntary reports of adverse events temporally associated with maprotiline that have been received since market introduction and that may have no casual relationship with the drug include the following: interstitial pneumonitis which were in some cases associated with eosinophilia and increased liver enzymes, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.
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REPORTS OF SUSPECTED MAPROTILINE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Maprotiline. The information is not vetted and should not be considered as verified clinical evidence.
Possible Maprotiline side effects / adverse reactions in 61 year old female
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-06-28
Patient: 61 year old female
Reactions: Blood Pressure Increased, Dyspnoea, Pain in Extremity, Nausea, Headache, Fall, Paraesthesia, Fatigue, Diarrhoea, Joint Swelling, Oedema Peripheral, Visual Impairment, Dizziness, Muscle Spasms, Cough
Suspect drug(s):
Rasilez
Dosage: 150/ 12.5 mg
Administration route: Oral
Indication: Essential Hypertension
Start date: 2010-01-01
Nebivolol
Dosage: 2.5 mg
Administration route: Oral
Indication: Essential Hypertension
Start date: 2010-01-01
Maprotiline
Administration route: Oral
Indication: Depression
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