"July 22, 2015 -- New results from ongoing clinical trials have fueled hopes for a class of Alzheimer's drugs that target the buildup of sticky plaque in the brain linked to the disease.
The data, presented Wednesday to a standing-room-only "...
Razadyne ER Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
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.
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.
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 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.
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 right away if you have any serious side effects, including: fainting, unusually slow heartbeat, difficult urination.
Get medical help right away if you have any very serious side effects, including: 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
Serious adverse reactions are discussed in more detail in the following sections of the labeling:
- Serious skin reactions [see WARNINGS AND PRECAUTIONS]
- Cardiovascular Conditions [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Conditions [see WARNINGS AND PRECAUTIONS]
- Genitourinary Conditions [see WARNINGS AND PRECAUTIONS]
- Neurological Conditions [see WARNINGS AND PRECAUTIONS]
- Pulmonary Conditions [see WARNINGS AND PRECAUTIONS]
- Deaths in subjects with mild cognitive impairment (MCI) [see WARNINGS AND PRECAUTIONS]
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
|System/Organ Class Adverse Reaction||Galantamine
|Metabolism and Nutrition Disorders|
|Nervous System Disorders|
|Musculoskeletal and Connective Tissue Disorders|
|General Disorders and Administration Site Conditions|
|Injury, Poisoning and Procedural Complications|
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
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%).
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
Vascular Disorders: Hypertension
Hepatobiliary Disorders: Hepatitis, Increased hepatic enzyme
Read the entire FDA prescribing information for Razadyne ER (Galantamine HBr ER)
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