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The safety information provided here outlines important considerations and potential risks associated with the use of zafirlukast (Accolate). Please read carefully and discuss any concerns with your healthcare provider.

• Not Suitable for Acute Asthma Attacks: Zafirlukast (Accolate) is effective for long-term asthma management but not for immediate relief of asthma attacks. Always carry a rescue inhaler for sudden asthma symptoms. Continue using zafirlukast as prescribed, even during an asthma attack.

• Risk of Liver Damage: Although uncommon, zafirlukast may cause liver damage. Symptoms such as pain in the upper right abdomen, nausea, fatigue, jaundice, flu-like symptoms, or appetite loss should prompt immediate medical attention, especially if there is a history of liver issues.

• Mental Health Concerns: Some patients may experience depression, mood changes, or insomnia. Contact your healthcare provider immediately if you or someone else notices feelings of sadness, loss of interest in activities, or sleep disturbances.

• High White Blood Cell Levels (Eosinophilia): Rarely, zafirlukast has been linked to symptoms associated with elevated white blood cell levels, such as severe itching, rash, breathing difficulties, tingling, or sinus pain and swelling. This risk increases if you are reducing or stopping an oral corticosteroid. Report these symptoms promptly.

• Increased Bleeding Risk with Warfarin: Combining zafirlukast with warfarin (Coumadin) can heighten bleeding risk. Inform your healthcare provider managing your blood thinner treatment to ensure close monitoring and possible dose adjustments.

Contraindications:

• Individuals with liver conditions, including cirrhosis, should not use this medication. Consult your healthcare provider if you have any liver-related health concerns before starting treatment with zafirlukast.

Common side effects:

• Headaches
• Nausea
• Vomiting
• Diarrhea
• Stomach pain
• General pain
• Muscle or back pain
• Dizziness
• Weakness
• Fever

Serious side effects:

• Serious allergic reactions (trouble breathing, hives, rashes, blisters on the skin, swelling of the face, lips, or tongue)
• Liver problems (upper right stomach pain, persistent nausea, tiredness, flu-like symptoms, loss of appetite, yellowing of the skin or eyes)
• Mental or mood changes (depression, agitation, trouble sleeping, thoughts of self-harm)
• Persistent infections
• Numbness or tingling in the limbs
• Chest pain
• Coughing up blood
• Worsening shortness of breath
• Muscle or joint pain
• Swelling of the ankles or feet

Interactions with high risk of serious adverse effects and should be avoided:

• Warfarin

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Erythromycin
• Terfenadine
• Theophylline