Razadyne ER Side Effects

Generic name: galantamine

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

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

For the Consumer

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

Get emergency medical help if you have any of these signs of an allergic reaction while taking galantamine (the active ingredient contained in Razadyne ER) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using galantamine and call your doctor at once if you have a serious side effect such as:

• chest pain, slow heart rate;

• feeling like you might pass out;

• blood in your urine or stool;

• coughing up blood or vomit that looks like coffee grounds;

• painful or difficult urination;

• urinating less than usual or not at all;

• weakness, confusion, decreased sweating, extreme thirst, hot dry skin; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of galantamine may include:

• feeling tired, dizzy, or drowsy;

• headache, blurred vision, runny nose;

• depression, sleep problems (insomnia);

• nausea, vomiting, stomach pain, loss of appetite;

• weight loss; or

• unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to galantamine: 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 (the active ingredient contained in Razadyne ER) (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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