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Accolate

Last reviewed on RxList: 2/25/2016
Accolate Side Effects Center

Last reviewed on RxList 12/16/2016

Accolate (zafirlukast) is a leukotriene inhibitor used to treat and prevent asthma attacks in adults and children as young as 5 years old. Do not give Accolate to a child without a doctor's advice. Accolate is available in generic form. Common side effects of Accolate include:

Tell your doctor if you have rare but very serious side effects of Accolate including:

  • mental/mood changes (e.g., agitation, aggression, hallucinations, abnormal dreams, depression, suicidal thoughts/suicide),
  • worsening shortness of breath,
  • tingling or swelling of the hands or feet,
  • coughing up blood,
  • chest pain,
  • easy bruising or bleeding, or
  • signs of infection (e.g., fever, persistent sore throat).

The recommended dose of Accolate in adults and children 12 years and older is 20 mg twice daily. The recommended dose in children 5 through 11 years of age is 10 mg twice daily. Accolate may interact with aspirin, blood thinners, tolbutamide, erythromycin, theophylline, carbamazepine, or phenytoin. Tell your doctor all medications you use. Accolate should be used during pregnancy only if prescribed. This medication passes into breast milk. Breastfeeding while using this medication is not recommended.

Our Accolate (zafirlukast) 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.

Accolate Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • worsening asthma symptoms;
  • new or worsening cough, fever, trouble breathing;
  • mood or behavior changes, anxiety, depression, sleep problems (insomnia);
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
  • nausea, pain in your upper stomach, loss of appetite, flu symptoms, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache;
  • diarrhea, stomach pain;
  • weakness;
  • dizziness;
  • muscle pain; or
  • sore throat, cold symptoms.

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.

Read the entire detailed patient monograph for Accolate (Zafirlukast)

Accolate Professional Information

SIDE EFFECTS

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.

Adverse Event ACCOLATE
N=4058
PLACEBO
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%

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 (see WARNINGS, Hepatotoxicity and PRECAUTIONS, PATIENT INFORMATION).

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 with asthma on ACCOLATE 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. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. These events have usually, but not always, been associated with reductions and/or withdrawal of steroid therapy. The possibility that ACCOLATE may be associated with emergence of Churg-Strauss syndrome can neither be excluded nor established (see PRECAUTIONS, Eosinophilic Conditions).

Neuropsychiatric adverse events, including insomnia and depression, have been reported in association with ACCOLATE therapy (see PRECAUTIONS, Neuropsychiatric Events). Hypersensitivity reactions, including urticaria, angioedema and rashes, with or without blistering, have also been reported in association with ACCOLATE therapy. Additionally, there have been reports of patients experiencing agranulocytosis, bleeding, bruising, or edema, arthralgia, myalgia, 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 (see CLINICAL PHARMACOLOGY and PRECAUTIONS: DRUG INTERACTIONS).

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.

Read the entire FDA prescribing information for Accolate (Zafirlukast)

Related Resources for Accolate

Read the Accolate User Reviews »

© Accolate Patient Information is supplied by Cerner Multum, Inc. and Accolate Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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