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Side Effects > Galantamine

Galantamine Side Effects

Brand Names: Razadyne, Razadyne ER

Please note - some side effects for Galantamine 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 Galantamine - for the Consumer

Galantamine

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 Galantamine:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; tiredness; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Galantamine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; chest pain; decreased urination; depression; fainting; fever; seizures; severe or persistent tiredness or weakness; slow or irregular heartbeat; tremor.

Galantamine Extended-Release Capsules

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 Galantamine Extended-Release Capsules:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; tiredness; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Galantamine Extended-Release Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; chest pain; decreased urination; depression; fainting; fever; seizures; severe or persistent tiredness or weakness; slow or irregular heartbeat; tremor.

Galantamine Solution

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 Galantamine Solution:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; tiredness; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Galantamine Solution:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; chest pain; decreased urination; depression; fainting; fever; seizures; severe or persistent tiredness or weakness; slow or irregular heartbeat; tremor.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

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Galantamine Side Effects - for the Professional

Galantamine

Premarketing Clinical Trial Experience

The specific adverse event data described in this section are based on studies of the immediate-release tablet formulation. In clinical trials, once-daily treatment with Galantamine hydrobromide extended-release capsules was well tolerated and adverse events were similar to those seen with Galantamine tablets.

Adverse Events Leading to Discontinuation

In two large scale, placebo-controlled trials of 6 months duration in which patients were titrated weekly from 8 to 16 to 24, and to 32 mg/day, the risk of discontinuation because of an adverse event in the Galantamine group exceeded that in the placebo group by about threefold. In contrast, in a 5 month trial with escalation of the dose by 8 mg/day every 4 weeks, the overall risk of discontinuation because of an adverse event was 7%, 7%, and 10% for the placebo, Galantamine 16 mg/day, and Galantamine 24 mg/day groups, respectively, with gastrointestinal adverse effects the principal reason for discontinuing Galantamine. Table 1 shows the most frequent adverse events leading to discontinuation in this study.

Table 1: Most Frequent Adverse Events Leading to Discontinuation in a Placebo-Controlled, Double-Blind Trial With a 4 Week Dose Escalation Schedule
4 Week Escalation
Placebo 16 mg/day 24 mg/day
Adverse Event N = 286 N = 279 N = 273
Nausea < 1% 2% 4%
Vomiting 0% 1% 3%
Anorexia < 1% 1% < 1%
Dizziness < 1% 2% 1%
Syncope 0% 0% 1%
Adverse Events Reported in Controlled Trials

The reported adverse events in trials using Galantamine tablets reflect experience gained under closely monitored conditions in a highly selected patient population. In actual practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior and the types of patients treated may differ.

The majority of these adverse events occurred during the dose-escalation period. In those patients who experienced the most frequent adverse event, nausea, the median duration of the nausea was 5 to 7 days.

Administration of Galantamine hydrobromide with food, the use of anti-emetic medication, and ensuring adequate fluid intake may reduce the impact of these events.

The most frequent adverse events, defined as those occurring at a frequency of at least 5% and at least twice the rate on placebo with the recommended maintenance dose of either 16 or 24 mg/day of Galantamine hydrobromide under conditions of every 4 week dose-escalation for each dose increment of 8 mg/day, are shown in Table 2. These events were primarily gastrointestinal and tended to be less frequent with the 16 mg/day recommended initial maintenance dose.

Table 2: The Most Frequent Adverse Events in the Placebo-Controlled Trial with Dose Escalation Every 4 Weeks Occurring in at Least 5% of Patients Receiving Galantamine Hydrobromide and at Least Twice the Rate on Placebo
Placebo Galantamine Galantamine
16 mg/day 24 mg/day
Adverse Event N = 286 N = 279 N = 273
Nausea 5% 13% 17%
Vomiting 1% 6% 10%
Diarrhea 6% 12% 6%
Anorexia 3% 7% 9%
Weight decrease 1% 5% 5%

Table 3: The most common adverse events (adverse events occurring with an incidence of at least 2% with Galantamine hydrobromide treatment and in which the incidence was greater than with placebo treatment) are listed in Table 3 for four placebo-controlled trials for patients treated with 16 or 24 mg/day of Galantamine hydrobromide.

Table 3: Adverse Events Reported in at Least 2% of Patients With Alzheimer’s Disease Administered Galantamine Hydrobromide and at a Frequency Greater Than With Placebo
*
Adverse events in patients treated with 16 or 24 mg/day of Galantamine hydrobromide in four placebo-controlled trials are included.
Body System Adverse Event Placebo Galantamine Hydrobromide *
(N = 801) (N = 1040)
Body as a whole – general disorders
Fatigue 3% 5%
Syncope 1% 2%
Central & peripheral nervous system disorders
Dizziness 6% 9%
Headache 5% 8%
Tremor 2% 3%
Gastrointestinal system disorders
Nausea 9% 24%
Vomiting 4% 13%
Diarrhea 7% 9%
Abdominal pain 4% 5%
Dyspepsia 2% 5%
Heart rate and rhythm disorders
Bradycardia 1% 2%
Metabolic and nutritional disorders
Weight decrease 2% 7%
Psychiatric disorders
Anorexia 3% 9%
Depression 5% 7%
Insomnia 4% 5%
Somnolence 3% 4%
Red blood cell disorders
Anemia 2% 3%
Respiratory system disorders
Rhinitis 3% 4%
Urinary system disorders
Urinary tract infection 7% 8%
Hematuria 2% 3%

Adverse events occurring with an incidence of at least 2% in placebo-treated patients that was either equal to or greater than with Galantamine hydrobromide treatment were constipation, agitation, confusion, anxiety, hallucination, injury, back pain, peripheral edema, asthenia, chest pain, urinary incontinence, upper respiratory tract infection, bronchitis, coughing, hypertension, fall, and purpura.

There were no important differences in adverse event rates related to dose or sex. There were too few non-Caucasian patients to assess the effects of race on adverse event rates.

No clinically relevant abnormalities in laboratory values were observed.

Other Adverse Events Observed During Clinical Trials

Galantamine tablets were administered to 3055 patients with Alzheimer’s disease. A total of 2357 patients received Galantamine in placebo-controlled trials and 761 patients with Alzheimer’s disease received Galantamine 24 mg/day, the maximum recommended maintenance dose. About 1000 patients received Galantamine for at least one year and approximately 200 patients received Galantamine for two years.

To establish the rate of adverse events, data from all patients receiving any dose of Galantamine hydrobromide in 8 placebo-controlled trials and 6 open-label extension trials were pooled. The methodology to gather and codify these adverse events was standardized across trials, using WHO terminology. All adverse events occurring in approximately 0.1% are included, except for those already listed elsewhere in labeling, WHO terms too general to be informative, or events unlikely to be drug caused. Events are classified by body system and listed using the following definitions: frequent adverse events – those occurring in at least 1/100 patients; infrequent adverse events – those occurring in 1/100 to 1/1000 patients; rare adverse events – those occurring in fewer than 1/1000 patients. These adverse events are not necessarily related to Galantamine hydrobromide treatment and in most cases were observed at a similar frequency in placebo-treated patients in the controlled studies. Additional adverse events observed in other clinical trials are also included below.

Body As a Whole – General Disorders: Frequent: chest pain, asthenia, fever, malaise

Cardiovascular System Disorders: Infrequent: postural hypotension, hypotension, dependent edema, cardiac failure, myocardial ischemia or infarction

Central & Peripheral Nervous System Disorders: Infrequent: vertigo, hypertonia, convulsions, involuntary muscle contractions, paresthesia, ataxia, hypokinesia, hyperkinesia, apraxia, aphasia, leg cramps, tinnitus, transient ischemic attack or cerebrovascular accident

Gastrointestinal System Disorders: Frequent: flatulence; Infrequent: gastritis, melena, dysphagia, rectal hemorrhage, dry mouth, saliva increased, diverticulitis, gastroenteritis, hiccup; Rare: esophageal perforation

Heart Rate & Rhythm Disorders: Infrequent: AV block, palpitation, atrial arrhythmias including atrial fibrillation and supraventricular tachycardia, QT prolonged, bundle branch block, T-wave inversion, ventricular tachycardia; Rare: severe bradycardia

Metabolic & Nutritional Disorders: Infrequent: hyperglycemia, alkaline phosphatase increased

Platelet, Bleeding & Clotting Disorders: Infrequent: purpura, epistaxis, thrombocytopenia

Psychiatric Disorders: Infrequent: apathy, paroniria, paranoid reaction, libido increased, delirium; Rare: suicidal ideation, suicide

Urinary System Disorders: Frequent: incontinence; Infrequent: hematuria, micturition frequency, cystitis, urinary retention, nocturia, renal calculi

Postmarketing Experience

Other adverse events from post-approval controlled and uncontrolled clinical trials and postmarketing experience observed in patients treated with Galantamine hydrobromide include:

Body as a Whole – General Disorders: dehydration (including rare, severe cases leading to renal insufficiency and renal failure)

Psychiatric Disorders: aggression

Gastrointestinal System Disorders: upper and lower GI bleeding

Metabolic & Nutritional Disorders: hypokalemia

These adverse events may or may not be causally related to the drug.

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Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects including nausea (24%), vomiting (13%), diarrhea (9%), abdominal pain (5%), and dyspepsia (5%) have been reported.

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.

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.

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