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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%


  • Rarely elevated levels of some or all liver enzymes have been seen when patients were treated with Accolate in controlled clinical studies. When clinical studies were conducted, the majority of these were observed at doses that were four times more than the recommended dosage.
  • The following liver instances (which occur mostly in females) were reported in postmarketing surveillance for adverse events of patients who have taken the recommended dosage of Accolate (40 mg/day) instances of symptoms-related liver disease (with and without hyperbilirubinemia) with no other causes; and, occasionally hyperbilirubinemia that is not accompanied by other elevated levels of liver function.
  • In the majority, but not all postmarketing reports, symptoms of the patient diminished and blood tests showed that the liver’s enzymes had returned to their normal or near-normal levels after discontinuing Accolate. In rare instances, patients may have developed severe hepatitis, or advanced to hepatic failure, transplantation, and even death.
  • Clinical trials revealed that an increase in the number of patients suffering from zafirlukast who were over 55 years had reported an infection as opposed to placebo-treated subjects. The same result was not seen in other age groups that were studied. The infections were generally moderate or light in severity and mostly involved in the respiratory tract.
  • The infections were equally prevalent in both genders, were dose-proportional to the total milligrams of zafirlukast, and were associated with the coadministration of corticosteroids inhaled. The medical significance of this discovery is not known.
  • In rare instances, patients taking Accolate therapy could develop an eosinophilic infection, systemic eosinophilia or other clinical signs of vasculitis that are consistent with the Churg-Strauss condition that is typically treated with treatment with systemic steroids. These types of events typically occur but not always are associated with the diminution of oral steroid treatment.
  • Doctors should be aware of vasculitic rash, eosinophilia worsening symptoms in the lungs, cardiac problems or neuropathy that are seen within their patients. The causal link between Accolate and the underlying condition isn’t yet proven.
  • Neuropsychiatric side effects, such as depression and insomnia were documented in connection with Accolate treatment  Hypersensitivity reactions, such as angioedema, rashes, and urticaria that are blister-free or not as well as blistering, have been reported as a result of Accolate therapy. There have also been reports of patients suffering from bleeding, bruising, or agranulocytosis or edema, arthritis as well as myalgia, malaise and pruritus as a result of Accolate therapy.
  • Rarely, patients experience higher levels of theophylline with or without symptoms or signs of theophylline toxicity following the introduction of Accolate into an established theophylline regimen has been documented. The mechanism behind this interaction Accolate and theophylline for these cases is unclear and cannot be predicted by data available research in vitro metabolic data or the outcomes of two studies of drug interactions 

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.

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

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