Accolate side effects

Generic name: zafirlukast 
The brand name is Accolate
The class of drug: Leukotriene modifiers


Accolate side effects


Accolate side effectsAccolate side effects are the unwanted reactions that come with the intake of this medication. Accolate is a leukotriene inhibitor used to treat asthma attacks in adults as well as children from 5 years old. young.

Accolate side effects are briefed in the following paragraphs 


Contact your physician immediately when you are experiencing indications of inflammation of the blood vessels such as flu-like symptoms, severe sinus discomfort, a skin rash and numbness, or a “pins or needles” sensation in your legs or arms.

Take a break from Accolate and consult your physician immediately if you notice any unusual changes in your mood or your behaviour (such as agitation, disorientation or depression, sleep issues or hallucinations, compulsive behaviour or hallucinations as well as suicidal thoughts or behaviours).


Children and adults aged 12 and older

Safety databases for Accolate include greater than 4000 healthy participants and patients who were treated with Accolate from 1723 patients whose asthmatics were enrolled in trials lasting 13 weeks or more. Six71 patients received Accolate over a period of one year or more. The majority of patients were aged 18 or older. However, there were 222 patients who were aged between 12-18 years were treated with Accolate.

A study of adverse events that were reported by more than 1% of patients receiving zafirlukast treatment and at rates that are higher than those reported by placebo-treated patients is displayed for all studies in the table below.

Adverse Event N=4058 N=2032
Headache 12.9% 11.7%
Infection 3.5% 3.4%
Nausea 3.1% 2.0%
Diarrhea 2.8% 2.1%
Pain (generalized) 1.9% 1.7%
Asthenia 1.8% 1.6%
Abdominal Pain 1.8% 1.1%
Accidental Injury 1.6% 1.5%
Dizziness 1.6% 1.5%
Myalgia 1.6% 1.5%
Fever 1.6% 1.1%
Back Pain 1.5% 1.2%
Vomiting 1.5% 1.1%
SGPT Elevation 1.5% 1.1%
Dyspepsia 1.3% 1.2%


Pediatric Patients 5-11 years old

Accolate has been tested for safety in 788 infant patients between 5 and 11 years old. In total, 313 children have been treated with Accolate 10 mg daily or more for at least 6 months and 113 were treated for a year or more as part of clinical trials.

The safety characteristics for Accolate 10 mg two times daily versus placebo in the four and 6-week double-blind trials was generally comparable to the one observed in adult clinical trials using Accolate 20 mg once daily.

For pediatric patients who received Accolate as part of multi-dose clinical trials, The following symptoms were observed with a frequency of greater than 2percent and were more frequent than pediatric patients who received placebo regardless of causality evaluation migraine (4.5 against. 4.2%) as well as abdominal discomfort.

More details

Always consult your doctor to make sure the information presented on this site is appropriate to your particular situation.

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