Ludiomil Side Effects

Generic Name: maprotiline

Please note - some side effects for Ludiomil 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).

Ludiomil Side Effects - for the Professional

Ludiomil

The following adverse reactions have been noted with Ludiomil 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 Ludiomil.

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 Ludiomil, its pharmacologic similarity to tricyclic antidepressants requires that each reaction be considered when administering Ludiomil.

• 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.

Post-Introduction Reports

Several voluntary reports of interstitial pneumonitis, which were in some cases associated with eosinophilia and increased liver enzymes, have been received since market introduction. However, there is no clear causal relationship.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects including dry mouth (22%), constipation (6%), and nausea (2%) have been reported. Vomiting, epigastric distress, diarrhea, bitter taste, abdominal cramps, increased salivation, and dysphagia have rarely been reported.

Nervous system

Nervous system side effects including drowsiness (16%), dizziness (8%), and tremor (3%) have been reported. Numbness, tingling, motor hyperactivity, akathisia, seizures, EEG alterations, tinnitus, extrapyramidal symptoms, ataxia, and dysarthria have rarely been reported.

Psychiatric

Psychiatric side effects including nervousness (6%), anxiety (3%), insomnia (2%), and agitation (2%) have been reported. Confusion (especially in the elderly), hallucinations, disorientation, delusions, restlessness, nightmares, hypomania, mania, exacerbation of psychosis, decrease in memory, and feelings of unreality have rarely been reported.

General

General side effects including weakness and fatigue (4%), headache (4%), and drug fever have been reported. Weight loss or gain has rarely been reported.

Ocular

Ocular side effects including blurred vision (4%) have been reported. Accommodation disturbances and mydriasis have rarely been reported.

Cardiovascular

Cardiovascular side effects including hypertension, hypotension, tachycardia, edema, arrhythmia, heart block, palpitation, and syncope have rarely been reported.

Genitourinary

Genitourinary side effects including urinary retention and delayed micturition have been reported. Urinary frequency has rarely been reported.

Dermatologic

Dermatologic side effects including skin rash, petechiae, itching, alopecia, excessive perspiration, flushing, and photosensitization have rarely been reported.

Endocrine

Endocrine side effects including increased or decreased libido, impotence, and elevation or depression of blood sugar levels have rarely been reported.

Hepatic

Hepatic side effects including altered liver function and jaundice have rarely been reported.

Respiratory

Respiratory side effects including several cases of interstitial pneumonitis have been reported. Nasal congestion has rarely been reported.

In some of the cases, the interstitial pneumonitis was associated with eosinophilia and increased liver enzymes. However, no clear causal relationship to maprotiline has been established.

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