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Hismanal

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Hismanal

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Hismanal Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Hismanal (astemizole) is an antihistamine used to treat allergies, hives (urticaria), and other allergic inflammatory conditions. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include drowsiness, dizziness, headache, nervousness, nausea, diarrhea, abdominal discomfort, dry mouth, dry skin, or itchiness.

The recommended dosage of Hismanal for adults and children 12 years of age and older is 10 mg (1 tablet) once daily. Hismanal may interact with antifungal drugs, antibiotics, quinine, nefazodone, selective serotonin reuptake inhibitors (SSRI), protease inhibitors, or zileuton. Tell your doctor all medications and supplements you use. It is unknown if Hismanal will harm a fetus. Do not take this medication without first talking to your doctor if you are pregnant. It is also unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Hismanal (astemizole) 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.

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
Headache
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
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)) »

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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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