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Ludiomil Side Effects

Generic Name: maprotiline

Note: This document contains side effect information about maprotiline. Some of the dosage forms listed on this page may not apply to the brand name Ludiomil.

For the Consumer

Applies to maprotiline: oral tablet

Along with its needed effects, maprotiline (the active ingredient contained in Ludiomil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking maprotiline:

More common
  • Skin rash, redness, swelling, or itching
Less common
  • Constipation (severe)
  • nausea or vomiting
  • shakiness or trembling
  • seizures (convulsions)
  • unusual excitement
  • weight loss
Rare
  • Breast enlargement—in males and females
  • confusion (especially in the elderly)
  • difficulty in urinating
  • fainting
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • inappropriate secretion of milk—in females
  • irregular heartbeat (pounding, racing, skipping)
  • sore throat and fever
  • swelling of testicles
  • yellow eyes or skin
Symptoms of overdose
  • Convulsions (seizures)
  • dizziness (severe)
  • drowsiness (severe)
  • fast or irregular heartbeat
  • fever
  • muscle stiffness or weakness (severe)
  • restlessness or agitation
  • trouble in breathing
  • vomiting

Some side effects of maprotiline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Blurred vision
  • decreased sexual ability
  • dizziness or lightheadedness (especially in the elderly)
  • drowsiness
  • dryness of mouth
  • headache
  • increased or decreased sexual drive
  • tiredness or weakness
Less common
  • Constipation (mild)
  • diarrhea
  • heartburn
  • increased appetite and weight gain
  • increased sensitivity of skin to sunlight
  • increased sweating
  • trouble in sleeping
  • weight loss

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

For Healthcare Professionals

Applies to maprotiline: oral tablet

General

The most commonly reported side effects include dry mouth, drowsiness, and dizziness.[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 22%)
Common (1% to 10%): Constipation, nausea
Rare (0.01% to 0.1%): Vomiting, epigastric distress, diarrhea, bitter taste, abdominal cramps, dysphagia, increased salivation
Frequency not reported: Sublingual adenitis, black tongue, stomatitis, paralytic ileus[Ref]

Nervous system

Very common (10% or more): Drowsiness (up to 16%)
Common (1% to 10%): Dizziness, tremor, headache
Rare (0.01% to 0.1%): Decreased memory, numbness, tingling, motor hyperactivity, akathisia, EEG alterations, extrapyramidal symptoms, ataxia, dysarthria
Frequency not reported: Stroke, peripheral neuropathy[Ref]

Psychiatric

Common (1% to 10%): Nervousness, anxiety, insomnia, agitation
Rare (0.01% to 0.1%): Confusional states, hallucinations, disorientation, delusions, restlessness, nightmares, hypomania, mania, psychosis exacerbation, feelings of unreality, decreased libido[Ref]

Other

Common (1% to 10%): Weakness, fatigue
Rare (0.01% to 0.1%): Tinnitus, drug fever[Ref]

Ocular

Common (1% to 10%): Blurred vision
Rare (0.01% to 0.1%): Accommodation disorder, mydriasis[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Hypotension, hypertension, tachycardia, palpitation, arrhythmia, heart block, syncope, edema
Frequency not reported: Myocardial infarction[Ref]

Dermatologic

Rare (0.01% to 0.1%): Skin rash, petechia, itching, photosensitization, excessive perspiration, flushing, alopecia
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis[Ref]

Genitourinary

Rare (0.01% to 0.1%): Urinary retention, delayed micturition, impotence, urinary frequency
Frequency not reported: Breast enlargement (in women), galactorrhea, testicular swelling[Ref]

Hepatic

Rare (0.01% to 0.1%): Altered liver function, jaundice
Postmarketing reports: Increased liver enzymes[Ref]

Metabolic

Rare (0.01% to 0.1%): Elevation/depression of blood sugar levels, weight loss or gain[Ref]

Respiratory

Rare (0.01% to 0.1%): Nasal congestion
Postmarketing reports: Interstitial pneumonitis[Ref]

Interstitial pneumonitis was occasionally associated with eosinophilia and increased liver enzymes. However, no clear causal relationship to treatment has been established.[Ref]

Hematologic

Frequency not reported: Bone marrow depression, agranulocytosis, eosinophilia, purpura, thrombocytopenia[Ref]

Endocrine

Frequency not reported: Gynecomastia (in men)[Ref]

References

1. "Product Information. Ludiomil (maprotiline)." Ciba-Geigy Pharmaceuticals, East Hanover, NJ.

Some side effects of Ludiomil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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