"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.
Serious adverse reactions are discussed in more detail in the following sections of the labeling:
- Serious skin reactions [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, decreased appetite, and weight decreased.
The most common adverse reactions associated with discontinuation ( ≥ 1%) in galantamine-treated patients from double-blind clinical trials were nausea (7.7%), vomiting (4.1%), decreased appetite (1.9%), and dizziness (1.6%).
The safety of the extended-release capsule and immediate-release tablet formulations of galantamine was evaluated in 2932 galantamine-treated patients who participated in 7 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 7 placebo-controlled, double-blind clinical trials.
Table 1: Adverse Reactions Reported by ≥ 1% of
Galantamine-Treated Patients in Pooled Placebo-Controlled, Double-Blind
|Metabolism and Nutrition Disorders|
|Nervous System Disorders|
|Upper abdominal pain||2.0||1.4|
|Skin and Subcutaneous Tissue Disorders|
|Musculoskeletal and Connective Tissue Disorders|
|General Disorders and Administration Site Conditions|
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=2932) 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
Musculoskeletal and Connective Tissue Disorders: Muscular weakness
Injury, Poisoning and Procedural Complications: Fall
Discontinuations Due to Adverse Reactions
In the 7 placebo-controlled studies of adults, 379 (12.9%) galantamine-treated patients (N=2932) and 42 (2.8%) placebo patients (N=1525) discontinued due to an adverse reaction. Those events with an incidence of ≥ 0.5% in the galantamine-treated patients included nausea (225, 7.7%), vomiting (119, 4.1%), decreased appetite (56, 1.9%), dizziness (48, 1.6%), diarrhea (27, 0.9%), headache (26, 0.9%), decreased weight (24, 0.8%), and abdominal pain (15, 0.5%). Those events with an incidence of ≥ 0.5% in placebo patients included nausea (14, 0.9%) and dizziness (8, 0.5%).
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 Razadyne ER (galantamine hbr er) Side Effects Center for a complete guide to possible side effects
Use With Anticholinergics
Use With Cholinomimetics And Other Cholinesterase Inhibitors
A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol [see CLINICAL PHARMACOLOGY].
Read the Razadyne ER Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 2/20/2015
Additional Razadyne ER Information
Razadyne ER - User Reviews
Razadyne ER User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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