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Razadyne ER

Last reviewed on RxList: 3/3/2017
Razadyne ER Side Effects Center

Last reviewed on RxList 01/19/2017

Razadyne ER (galantamine hydrobromide) is a cholinesterase inhibitor that works by restoring the balance of certain natural substances (neurotransmitters) in the brain used to treat mild to moderate dementia caused by Alzheimer's disease. Razadyne ER is available in generic form. Common side effects of Razadyne ER include:

  • nausea,
  • vomiting,
  • stomach pain,
  • diarrhea,
  • dizziness,
  • loss of appetite,
  • weight loss,
  • tiredness,
  • drowsiness,
  • headache,
  • blurred vision,
  • runny nose,
  • depression,
  • sleep problems (insomnia), and
  • unusual or unpleasant taste in your mouth.

Tell your doctor if you have any serious side effects of Razadyne ER including:

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 breastfeeding.

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.

Razadyne ER Consumer Information

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 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Razadyne ER (Galantamine HBr ER)

Razadyne ER Professional Information

SIDE EFFECTS

Serious adverse reactions are discussed in more detail in the following sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reactions in galantamine-treated patients from double-blind clinical trials ( ≥ 5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.

The most common adverse reactions associated with discontinuation ( ≥ 1%) in galantamine-treated patients from double-blind clinical trials were nausea (6.2%), vomiting (3.3%), decreased appetite (1.5%), and dizziness (1.3%).

The safety of the extended-release capsule and immediate-release tablet formulations of galantamine was evaluated in 3956 galantamine-treated patients who participated in 8 placebo-controlled clinical studies and 1454 subjects in 5 open-label clinical studies with mild to moderate dementia of the Alzheimer's type. In clinical studies, the safety profile of once-daily treatment with extended-release galantamine was similar in frequency and nature to that seen with tablets. The information presented in this section was derived from pooled double-blind studies and from pooled open-label data.

Commonly-Observed Adverse Reactions In Double-Blind, Placebo-Controlled Clinical Trials

Table 1 lists the adverse reactions reported in ≥ 1% of galantamine-treated patients in 8 placebo-controlled, double-blind clinical trials.

Table 1: Adverse Reactions Reported by ≥ 1% of Galantamine-Treated Patients in Pooled Placebo-Controlled, Double-Blind Clinical Trials

System/Organ Class
Adverse Reaction
Galantamine
(n=3956) %
Placebo
(n=2546) %
Metabolism and Nutrition Disorders
  Decreased appetite 7.4 2.1
Psychiatric Disorders
  Depression 3.6 2.3
Nervous System Disorders
  Headache 7.1 5.5
  Dizziness 7.5 3.4
  Tremor 1.6 0.7
  Somnolence 1.5 0.8
  Syncope 1.4 0.6
  Lethargy 1.3 0.4
Cardiac Disorders
  Bradycardia 1.0 0.3
Gastrointestinal Disorders
  Nausea 20.7 5.5
  Vomiting 10.5 2.3
  Diarrhea 7.4 4.9
  Abdominal discomfort 2.1 0.7
  Abdominal pain 3.8 2.0
  Dyspepsia 1.5 1.0
Musculoskeletal and Connective Tissue Disorders
  Muscle spasms 1.2 0.5
General Disorders and Administration Site Conditions
  Fatigue 3.5 1.8
  Asthenia 2.0 1.5
  Malaise 1.1 0.5
Investigations
  Decreased weight 4.7 1.5
Injury, Poisoning and Procedural Complications
  Fall 3.9 3.0
  Laceration 1.1 0.5

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

Other Adverse Reactions Observed In Clinical Trials Of Galantamine

The following adverse reactions occurred in < 1% of all galantamine-treated patients (N=3956) in the above double-blind, placebo-controlled clinical trial data sets. In addition, the following also includes all adverse reactions reported at any frequency rate in patients (N=1454) who participated in open-label studies. Adverse reactions listed in Table 1 above were not included below:

Metabolism and Nutrition Disorders: Dehydration

Nervous System Disorders: Dysgeusia, Hypersomnia, Paresthesia

Eye Disorders: Blurred vision

Cardiac Disorders: First degree atrioventricular block, Palpitations, Sinus bradycardia, Supraventricular extrasystoles

Vascular Disorders: Flushing, Hypotension

Gastrointestinal Disorders: Retching

Skin and Subcutaneous Tissue Disorders: Hyperhidrosis

Musculoskeletal and Connective Tissue Disorders: Muscular weakness

Discontinuations Due To Adverse Reactions

In the 8 placebo-controlled studies of adults, 418 (10.6%) galantamine-treated patients (N=3956) and 56 (2.2%) placebo patients (N=2546) discontinued due to an adverse reaction. Those events with an incidence of ≥ 0.5% in the galantamine-treated patients included nausea (245, 6.2%), vomiting (129, 3.3%), decreased appetite (60, 1.5%), dizziness (50, 1.3%), diarrhea (31, 0.8%), headache (29, 0.7%), and decreased weight (26, 0.7%). The only event with an incidence of ≥ 0.5% in placebo patients was nausea (17, 0.7%).

In the 5 open-label studies, 103 (7.1%) patients (N=1454) discontinued due to an adverse reaction. Those events with an incidence of ≥ 0.5% included nausea (43, 3.0%), vomiting (23, 1.6%), decreased appetite (13, 0.9%), headache (12, 0.8%), decreased weight (9, 0.6%), dizziness (8, 0.6%), and diarrhea (7, 0.5%).

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of RAZADYNE® ER and RAZADYNE®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency:

Immune System Disorders: Hypersensitivity

Psychiatric Disorders: Hallucinations

Nervous System Disorders: Seizures

Ear and Labyrinth Disorders: Tinnitus

Cardiac Disorders: Complete atrioventricular block

Vascular Disorders: Hypertension

Hepatobiliary Disorders: Hepatitis, Increased hepatic enzyme

Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome, Acute generalized exanthematous pustulosis, Erythema multiforme

Read the entire FDA prescribing information for Razadyne ER (Galantamine HBr ER)

Related Resources for Razadyne ER

Read the Razadyne ER User Reviews »

© Razadyne ER Patient Information is supplied by Cerner Multum, Inc. and Razadyne ER Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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