Accolate Side Effects

Generic Name: zafirlukast

Note: This page contains information about the side effects of zafirlukast. Some of the dosage forms included on this document may not apply to the brand name Accolate.

Not all side effects for Accolate may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to zafirlukast: oral tablet

In addition to its needed effects, some unwanted effects may be caused by zafirlukast (the active ingredient contained in Accolate). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking zafirlukast:

Less common
  • Cough or hoarseness
  • fever or chills
  • lower back or side pain
  • pain
  • painful or difficult urination
Rare
  • Abdominal or stomach pain
  • clay-colored stools
  • dark urine
  • diarrhea
  • dizziness
  • headache
  • itching
  • loss of appetite
  • nausea
  • rash
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • yellow eyes or skin
Incidence not known
  • Attack, assault, or force
  • attempts at killing oneself
  • discouragement
  • dry mouth
  • fear or nervousness
  • feeling sad or empty
  • fever with or without chills
  • general feeling of tiredness or weakness
  • hyperventilation
  • irregular heartbeats
  • irritability
  • lack of appetite
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of interest or pleasure
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • sleeplessness
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • tiredness
  • trembling or shaking of the hands or feet
  • trouble with concentrating
  • trouble with sleeping
  • unable to sleep
  • unusual bleeding or bruising

Some of the side effects that can occur with zafirlukast may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Acid or sour stomach
  • back pain
  • belching
  • difficulty with moving
  • heartburn
  • indigestion
  • joint pain
  • lack or loss of strength
  • muscle aching or cramping
  • muscle pains or stiffness
  • stomach discomfort or upset
  • swollen joints
  • vomiting
Incidence not known
  • Hives or welts
  • redness of the skin

For Healthcare Professionals

Applies to zafirlukast: oral tablet

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 (the active ingredient contained in Accolate) 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 (the active ingredient contained in Accolate) 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.

Psychiatric

Psychiatric side effects have included insomnia and depression.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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