Accolate Side Effects

Generic Name: zafirlukast

Please note - some side effects for Accolate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Accolate - for the Consumer

Accolate

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Accolate:

Diarrhea; headache; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fever; flu-like symptoms; itching; joint or muscle aches and pains; loss of appetite; persistent nausea or stomach pain; tiredness; yellowing of the eyes or skin.

Accolate Side Effects - for the Professional

Accolate

Adults and Children 12 years of age and older

The safety database for Accolate consists of more than 4000 healthy volunteers and patients who received Accolate, of which 1723 were asthmatics enrolled in trials of 13 weeks duration or longer. A total of 671 patients received Accolate for 1 year or longer. The majority of the patients were 18 years of age or older; however, 222 patients between the age of 12 and 18 years received Accolate.

A comparison of adverse events reported by ≥1% of zafirlukast-treated patients, and at rates numerically greater than in placebo-treated patients, is shown for all trials in the table below.

The frequency of less common adverse events was comparable between Accolate and placebo.

Rarely, elevations of one or more liver enzymes have occurred in patients receiving Accolate in controlled clinical trials. In clinical trials, most of these have been observed at doses four times higher than the recommended dose. The following hepatic events (which have occurred predominantly in females) have been reported from postmarketing adverse event surveillance of patients who have received the recommended dose of Accolate (40 mg/day): cases of symptomatic hepatitis (with or without hyperbilirubinemia) without other attributable cause; and rarely, hyperbilirubinemia without other elevated liver function tests. In most, but not all postmarketing reports, the patient’s symptoms abated and the liver enzymes returned to normal or near normal after stopping Accolate. In rare cases, patients have presented with fulminant hepatitis or progressed to hepatic failure, liver transplantation and death.

In clinical trials, an increased proportion of zafirlukast patients over the age of 55 years reported infections as compared to placebo-treated patients. A similar finding was not observed in other age groups studied. These infections were mostly mild or moderate in intensity and predominantly affected the respiratory tract. Infections occurred equally in both sexes, were dose-proportional to total milligrams of zafirlukast exposure, and were associated with coadministration of inhaled corticosteroids. The clinical significance of this finding is unknown.

In rare cases, patients on Accolate therapy may present with systemic eosinophilia, eosinophilic pneumonia, or clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic steroid therapy. These events usually, but not always, have been associated with the reduction of oral steroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between Accolate and these underlying conditions has not been established.

Hypersensitivity reactions, including urticaria, angioedema and rashes, with or without blistering, have been reported in association with Accolate therapy. Additionally, there have been reports of patients experiencing agranulocytosis, bleeding, bruising, or edema, arthralgia, myalgia, insomnia, malaise, and pruritus in association with Accolate therapy.

Rare cases of patients experiencing increased theophylline levels with or without clinical signs or symptoms of theophylline toxicity after the addition of Accolate to an existing theophylline regimen have been reported. The mechanism of the interaction between Accolate and theophylline in these patients is unknown and not predicted by available in vitro metabolism data and the results of two clinical drug interaction studies.

Pediatric Patients 5 through 11 years of age

Accolate has been evaluated for safety in 788 pediatric patients 5 through 11 years of age. Cumulatively, 313 pediatric patients were treated with Accolate 10 mg twice daily or higher for at least 6 months, and 113 of them were treated for one year or longer in clinical trials. The safety profile of Accolate 10 mg twice daily-versus placebo in the 4- and 6-week double-blind trials was generally similar to that observed in the adult clinical trials with Accolate 20 mg twice daily.

In pediatric patients receiving Accolate in multi-dose clinical trials, the following events occurred with a frequency of ≥ 2% and more frequently than in pediatric patients who received placebo, regardless of causality assessment: headache (4.5 vs. 4.2%) and abdominal pain (2.8 vs. 2.3%).

The post-marketing experience in this age group is similar to that seen in adults, including hepatic dysfunction, which may lead to liver failure.

Side Effects by Body System

Nervous system

Nervous system side effects have included headache, asthenia, somnolence, dizziness, fever, insomnia, and pain.

Immunologic

A 47-year-old man with persistent asthma developed sinus congestion, cough, malaise, arthralgia, a progressive rash over his trunk and extremities, and fever within one month of reinitiating zafirlukast therapy. Prior to the development of these symptoms, the patient had been receiving inhaled steroids in combination with zafirlukast therapy. A skin eruption was observed on his face, arms, and trunk. A chest film showed basilar reticulonodular infiltrates, and laboratory findings revealed a positive titer for rheumatoid factor, a blood eosinophil count of 4,350 and an elevated total IgE level (851 intl units/L). The patient's prior medications were discontinued, and he was treated with intravenous hydrocortisone, acyclovir, ceftriaxone, and erythromycin. The patient demonstrated rapid improvement of all signs and symptoms following initiation of hydrocortisone. A causal relationship between zafirlukast therapy and the development of systemic vasculitis was suspected.

Following nearly two months of zafirlukast therapy, a 53-year-old female with a history of asthma and chronic sinusitis developed arthralgias involving her knees, wrists, shoulder and joints. She further developed amaurosis fugax and a hemorrhagic, maculopapular eruption on her elbows and fingers. Her chest film showed multiple pulmonary nodes, and a bronchoscopic lung biopsy revealed eosinophilic infiltrates and granulomas. The patient was initiated on high-dose steroid therapy after which all signs and symptoms promptly resolved. It was believed that this case report represented zafirlukast-induced Churg-Strauss syndrome independent of steroid therapy.

Immunologic side effects have included Churg-Strauss syndrome, also known as allergic granulomatosis, and drug-induced lupus. In addition, increased incidence of infection in patients over the age of 55 has been noted in clinical trials of patients receiving zafirlukast.

Gastrointestinal

Gastrointestinal side effects have included dry mouth, nausea, diarrhea, abdominal pain, vomiting and dyspepsia.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, myalgia and back pain.

Hepatic

In clinical trials, SGPT elevations were comparable between treatment and placebo groups. However, one case of hepatitis and hyperbilirubinemia was observed in a patient receiving zafirlukast 40 mg per day for 100 days.

Hepatic side effects have included elevations of hepatic transaminase levels.

General

General side effects have included malaise.

Dermatologic

Dermatologic side effects have included pruritus.

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