Razadyne ER
- Generic Name: galantamine hbr
- Brand Name: Razadyne
Razadyne (Galantamine HBr ) side effects drug center
Razadyne ER Side Effects Center
What Is Razadyne ER?
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.
What Are Side Effects of Razadyne ER?
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:
- fainting,
- unusually slow heartbeat, or
- difficult urination.
Dosage for Razadyne ER
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.
What Drugs, Substances, or Supplements Interact with Razadyne ER?
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 During Pregnancy and Breastfeeding
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.
Additional Information
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.
Razadyne ER Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Galantamine can cause serious skin reactions. Stop using this medicine and call your doctor at once if you have the first signs of any skin rash, no matter how mild.
Call your doctor at once if you have:
- chest pain, slow heart rate;
- little or no urinating;
- blood in your urine;
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
- a light-headed feeling, like you might pass out; or
- severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common side effects may include:
- nausea, vomiting, diarrhea, loss of appetite;
- headache, dizziness; or
- weight loss.
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 )
Razadyne ER Professional 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 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 |
| vSyncope | 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 )
&Copy; 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.