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Ludiomil (Maprotiline Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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.



REPORTS OF SUSPECTED LUDIOMIL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Ludiomil. The information is not vetted and should not be considered as verified clinical evidence.

Possible Ludiomil side effects / adverse reactions in 72 year old female

Reported by a pharmacist from Japan on 2012-02-24

Patient: 72 year old female weighing 42.0 kg (92.4 pounds)

Reactions: Hospitalisation, Hallucination, Visual, Saliva Altered

Adverse event resulted in: hospitalization

Suspect drug(s):
Depas

Neodopasol (Levodopa_benserazide Hydrochloride)
    Administration route: Oral
    Indication: Parkinson's Disease

Pramipexole Dihydrochloride
    Dosage: 1.5 mg
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-01-01
    End date: 2012-01-01

Ludiomil
    Administration route: Oral
    Indication: Depression

Aricept
    Dosage: 5 mg

Other drugs received by patient: Yoku-KAN-SAN; Comtan; LAC-B; Motilium; Lansoprazole; Loxonin; Selbex



Possible Ludiomil side effects / adverse reactions in 64 year old female

Reported by a physician from Japan on 2012-04-10

Patient: 64 year old female

Reactions: Drug Ineffective, Hallucination, Visual, Conversion Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Ludiomil
    Dosage: 35 mg, qd
    Administration route: Oral
    Start date: 2008-04-08

Ludiomil
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2008-04-15
    End date: 2008-04-18

Ludiomil
    Dosage: 75 mg, qd
    Administration route: Oral
    Start date: 2008-02-21

Ludiomil
    Dosage: 100 mg, divided into 100mg and 25mg
    Administration route: Oral
    Start date: 2008-03-06

Ludiomil
    Dosage: 85 mg, divided into 25mg and 60mg
    Administration route: Oral
    Start date: 2008-05-25

Ludiomil
    Dosage: 60 mg, divided into 50mg and 10mg
    Administration route: Oral
    Start date: 2008-04-01

Ludiomil
    Dosage: 25 mg, qd
    Administration route: Oral
    Start date: 2008-04-12

Ludiomil
    Dosage: 25 mg, daily
    Administration route: Oral
    Indication: Depression
    Start date: 2008-02-04

Ludiomil
    Dosage: 50 mg, qd
    Administration route: Oral
    Start date: 2008-02-13

Ludiomil
    Dosage: 75 mg, divided into 25mg and 50mg
    Administration route: Oral
    Start date: 2008-05-28

Ludiomil
    Dosage: 50 mg, qd
    Administration route: Oral
    Start date: 2008-04-05

Other drugs received by patient: Mucosta; Levothyroxine Sodium; Desyrel



See index of all Ludiomil side effect reports >>

Drug label data at the top of this Page last updated: 2006-02-22

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