Razadyne IR Side Effects

Please note - some side effects for Razadyne IR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: oral capsule, extended release; oral solution; oral tablet

Gastrointestinal

Gastrointestinal side effects including nausea (24%), vomiting (13%), diarrhea (9%), abdominal pain (5%), and dyspepsia (5%) have been reported. Gastrointestinal side effects reported postmarketing have included upper and lower GI bleeding, stomach discomfort, and abdominal discomfort.

General

General side effects including weight decrease (7%), fatigue (5%), and syncope (2%) have been reported. Chest pain, asthenia, fever, and malaise have been reported frequently.

In two randomized, placebo-controlled trials of two years duration in subjects with mild cognitive impairment, a total of 13 subjects on galantamine (n=1026) and 1 subject on placebo (n=1022) died. The deaths were due to various causes which could be expected in an elderly population. About half of the galantamine deaths appeared to result from various vascular causes (myocardial infarction, stroke), and sudden death.

Nervous system

Nervous system side effects including dizziness (9%), headache (8%), and tremor (3%) have been reported. Leg cramps, tinnitus, transient ischemic attacks and cerebrovascular accidents have been reported infrequently. Nervous system side effects reported postmarketing have included lethargy, dysgeusia, and hypersomnia.

Psychiatric

Psychiatric side effects including anorexia (9%), depression (7%), insomnia (5%), and somnolence (4%) have been reported. Apathy, paroniria (disagreeable or terrifying dreams), paranoid reaction, increased libido, and delirium have been reported infrequently. Suicidal ideation and suicide have been reported rarely.

Genitourinary

Genitourinary side effects including urinary tract infection (8%) and hematuria (3%) have been reported.

Respiratory

Respiratory side effects including rhinitis (4%) have been reported.

Hematologic

Hematologic side effects including anemia (3%) have been reported.

Cardiovascular

Cardiovascular side effects including bradycardia (up to 3%) have been reported. Postural hypotension, hypotension, dependent edema, cardiac failure, and myocardial ischemia or infarction, AV block, palpitation, atrial arrhythmias including atrial fibrillation and supraventricular tachycardia, QT prolonged, bundle branch block, T-wave inversion, and ventricular tachycardia have been reported infrequently. Severe bradycardia has rarely been reported.

Ocular

Ocular side effects reported postmarketing have included blurred vision.

Hepatic

Hepatic side effects reported postmarketing have included elevated liver enzymes and hepatitis.

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