"The costs of caring for people with dementia in the United States in 2010 were between $159 billion to $215 billion, and those costs could rise dramatically with the increase in the numbers of older people in coming decades, according to estimate"...
Razadyne ER Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Razadyne ER (galantamine hydrobromide) is used to treat mild to moderate dementia caused by Alzheimer's disease. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain. This medication is available in generic form. Common side effects include nausea, vomiting, diarrhea, dizziness, loss of appetite, and weight loss.
The recommended starting dose of Razadyne ER is 8 mg/day. The dose should be increased to the initial maintenance dose of 16 mg/day after a minimum of 4 weeks. A further increase to 24 mg/day should be attempted after a minimum of 4 weeks at 16 mg/day. Razadyne ER may interact with atropine, belladonna, clidinium, dicyclomine, glycopyrrolate, hyoscyamine, ketoconazole, mepenzolate, methantheline, methscopolamine, paroxetine, propantheline, or scopolamine. Tell your doctor all medications you use. Razadyne ER should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Razadyne ER (galantamine hydrobromide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Razadyne ER in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using galantamine and call your doctor at once if you have any of these serious side effects:
- chest pain, slow heart rate;
- black, bloody, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- weakness, confusion, decreased sweating, extreme thirst, hot dry skin; or
- urinating less than usual or not at all.
Less serious side effects may include:
- feeling tired, dizzy, or light-headed;
- nausea, vomiting, gas, loss of appetite;
- weight loss; or
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Razadyne ER (Galantamine HBr ER) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Razadyne ER Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, unusually slow heartbeat, difficult urination.
Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, black/bloody stools, vomit that looks bloody or like coffee grounds, severe stomach/abdominal pain, irregular heartbeat.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Razadyne ER (Galantamine HBr ER)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Razadyne ER FDA Prescribing Information: Side Effects
Pre-Marketing 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 RAZADYNE® ER (galantamine hydrobromide) Extended-Release Capsules was well tolerated and adverse events were similar to those seen with RAZADYNE® 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 principle 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
|Adverse Event||4-Week Escalation|
|Anorexia||< 1%||1%||< 1%|
Adverse Events Reported in Controlled Trials
The reported adverse events in trials using RAZADYNE® (galantamine hydrobromide) 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 5-7 days.
Administration of RAZADYNE® 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 RAZADYNE® 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 RAZADYNE® and at Least Twice the Rate
|RAZADYNE® 16 mg/day
|RAZADYNE® 24 mg/day
Table 3: The most common adverse events (adverse events occurring with an incidence of at least 2% with RAZADYNE® 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 RAZADYNE® .
Table 3: Adverse Events Reported in at Least 2% of
Patients With Alzheimer's Disease Administered RAZADYNE® and at a
Frequency Greater Than With Placebo
|Body as a whole - general disorders|
|Central & peripheral nervous system disorders|
|Gastrointestinal system disorders|
|Heart rate and rhythm disorders|
|Metabolic and nutritional disorders|
|Red blood cell disorders|
|Respiratory system disorders|
|Urinary system disorders|
|Urinary tract infection||7%||8%|
|1Adverse events in patients treated with 16 or 24 mg/day of RAZADYNE® in four placebo-controlled trials are included|
Adverse events occurring with an incidence of at least 2% in placebo-treated patients that was either equal to or greater than with RAZADYNE® 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
RAZADYNE® 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 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 RAZADYNE® 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.
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
Psychiatric Disorders: Infrequent: apathy, paroniria, paranoid reaction, libido increased, delirium; Rare: suicidal ideation, suicide
Other adverse events from post-approval controlled and uncontrolled clinical trials and post-marketing experience observed in patients treated with RAZADYNE® include:
Psychiatric Disorders: aggression
Gastrointestinal System Disorders: upper and lower GI bleeding
Hepatobiliary Disorders: elevated liver enzymes, hepatitis
Metabolic & Nutritional Disorders: hypokalemia
These adverse events may or may not be causally related to the drug.
Read the entire FDA prescribing information for Razadyne ER (Galantamine HBr ER) »
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