Marplan Side Effects

Generic Name: Isocarboxazid

Please note - some side effects for Marplan 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).

Side Effects of Marplan - for the consumer

Marplan

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Marplan:

Abnormal skin sensations; anxiety; blurred vision; chills; constipation; diarrhea; dizziness; drowsiness; dry mouth; fainting; forgetfulness; frequent urination; headache; heavy feeling; hyperactivity; inability to urinate; lack of energy; lightheadedness when rising from a seated or lying position; muscle jerks; nausea; sedation; sleep disturbance; sleeplessness; tremors; upset stomach.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; cold, clammy skin; difficulty sleeping; fast or irregular heartbeat; feelings of irritability or hostility; impotence; impulsive behavior or other unusual change in behavior; nausea; neck stiffness; panic attacks; pounding in the chest; sensitivity to light; severe headache; severe high blood pressure; severe nervousness or anxiety; severe restlessness; suicidal thoughts or behaviors; sweating; tightness in the throat or chest; vomiting; widened pupils; worsening feelings of depression; yellowing of the eyes or skin.

For the professional

Marplan

Adverse Findings Observed in Short-Term, Placebo-Controlled Trials

Systematically collected data are available from only 86 patients exposed to Marplan, of whom only 52 received doses of ≥50 mg/day, including only 11 who were dosed at ≥60 mg/day. Because of the limited experience with systematically monitored patients receiving Marplan at the higher end of the currently recommended dose range of up to 60 mg/day, caution is indicated in patients for whom a dose of 40 mg/day is exceeded.

The table that follows enumerates the incidence, rounded to the nearest percent, of treatment emergent adverse events that occurred among 86 depressed patients who received Marplan at doses ranging from 20 to 80 mg/day in placebo-controlled trials of 6 weeks in duration. Events included are those occurring in 1% or more of patients treated with Marplan and for which the incidence in patients treated with Marplan was greater than the incidence in placebo-treated patients.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

The commonly observed adverse event that occurred in Marplan patients with an incidence of 5% or greater and at least twice the incidence in placebo patients were nausea, dry mouth, and dizziness.

In three clinical trials for which the data were pooled, 4 of 85 (5%) patients who received placebo, 10 of 86 (12%) who received <50 mg of Marplan per day, and 1 of 52 (2%) who received ≥50 mg of Marplan per day prematurely discontinued treatment. The most common reasons for discontinuation were dizziness, orthostatic hypotension, syncope, and dry mouth.

Other Events Observed During the Postmarketing Evaluation of Marplan

Isolated cases of akathisia, ataxia, black tongue, coma, dysuria, euphoria, hematologic changes, incontinence, neuritis, photosensitivity, sexual disturbances, spider telangiectases, and urinary retention have been reported. These side effects sometimes necessitate discontinuation of therapy. In rare instances, hallucinations have been reported with high dosages, but they have disappeared upon reduction of dosage or discontinuation of therapy. Toxic amblyopia was reported in one psychiatric patient who had received isocarboxazid for about a year; no causal relationship to isocarboxazid was established. Impaired water excretion compatible with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) has been reported.

More resources:

Marplan

Marplan

Marplan - Includes detailed dosage instructions.

Marplan

Isocarboxazid

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