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.
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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
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