Hismanal
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Hismanal
Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)
Hismanal Side Effects Center
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.
Hismanal in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects, stop taking astemizole and call your doctor immediately or seek emergency medical attention:
- an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
- an irregular heartbeat;
- fainting; or
- seizures.
Other, less serious side effects may be more likely to occur. Continue to take astemizole and talk to your doctor if you experience
- drowsiness or dizziness;
- headache;
- nervousness;
- nausea, diarrhea, or abdominal discomfort;
- dry mouth; or
- dry skin or itchiness.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Read the entire detailed patient monograph for Hismanal (Astemizole (WITHDRAWN FROM US MARKET)) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Hismanal FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
For information regarding cardiovascular adverse events (e.g., cardiac arrest, ventricular arrhythmias), please see CONTRAINDICATIONS and WARNINGS. In some cases, recognition of severe arrhythmias has been preceded by episodes of syncope. Similarly, rare cases of hypotension, palpitations, and dizziness have also been reported with Astemizole use, which may reflect undetected ventricular arrhythmia.
In studies the usual maintenance dose of Astemizole was 10 mg once daily.
TABLE 1 - Astemizole, Adverse Reactions Percent of Patients Reporting Controlled Studies*
| Adverse Event | Astemizole | Placebo | Classical** |
| (N = 1630) | (N = 1109) | (N = 304) | |
| % | % | % | |
| Drowsiness | 7.1 | 6.4 | 22.0 |
| 6.7 | 9.2 | 3.3 | |
| 4.2 | 1.6 | 11.8 | |
| Appetite increase | 3.9 | 1.4 | 0.0 |
| Weight increase | 3.6 | 0.7 | 1.0 |
| Nervousness | 2.1 | 1.2 | 0.3 |
| Dizzy | 2.0 | 1.8 | 1.0 |
| Gastrointestinal System | |||
| 2.5 | 2.9 | 1.3 | |
| 1.8 | 2.0 | 0.7 | |
| 1.4 | 1.2 | 0.7 | |
| 5.2 | 3.8 | 7.9 | |
| 1.7 | 2.3 | 0.3 | |
| 1.2 | 1.2 | 0.7 | |
| Other | |||
| Arthralgia | 1.2 | 1.6 | 0.0 |
| * Duration of treatment in Controlled Studies ranged from 7 to 182 Days | |||
| ** Classical Drugs: Clemastine (N = 137); Chlorpheniramine (N = 100); Pheniramine Maleate (N = 47); d-Chlorpheniramine (N = 20) | |||
Adverse reaction information has been obtained from more than 7500 patients in all clinical trials. Weight gain has been reported in 3.6% of astemizole treated patients involved in controlled studies, with an average treatment duration of 53 days. In 46 of the 59 patients for whom actual weight gain data was available, the average weight gain was 3.2 kg.
Less frequently occurring adverse experiences reported in clinical trials or spontaneously from marketing experience with Astemizole include: angioedema, asymptomatic liver enzyme elevations, bronchospasm, depression, edema, epistaxis, myalgia, palpitation, paresthesia, photosensitivity, pruritus, and rash.
Marketing experiences include isolated cases of convulsions. A causal relationship with Astemizole has not been established.
Read the entire FDA prescribing information for Hismanal (Astemizole (WITHDRAWN FROM US MARKET)) »
Additional Hismanal Information
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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