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The safety information below highlights essential warnings and precautions for using this medication. Review these carefully and contact your healthcare provider if you have any questions or concerns.

• Not for Immediate Asthma Relief: Zafirlukast (Accolate) is effective for long-term asthma management but is not a substitute for a rescue inhaler during an asthma attack. Always carry your rescue inhaler and continue using zafirlukast (Accolate) as directed, even during an attack.

• Risk of Liver Damage: Although uncommon, there is a potential for liver damage when taking zafirlukast (Accolate). Most cases resolve after discontinuation, but in rare instances, it can progress to life-threatening liver failure. Contact your healthcare provider immediately if you experience symptoms such as upper right abdominal pain, nausea, fatigue, jaundice, flu-like symptoms, or loss of appetite. Those with a history of liver issues are at increased risk.

• Mood Changes and Depression: Some users have reported depression and sleep disturbances. Notify your provider promptly if you or those around you observe feelings of sadness, loss of interest in activities, insomnia, or other depressive symptoms.

• Eosinophilia and Related Conditions: Rarely, zafirlukast (Accolate) may cause elevated white blood cell levels, potentially leading to symptoms like severe itching, rash, breathing difficulties, tingling or numbness in extremities, and sinus pain or swelling. These symptoms are more likely if you are reducing or stopping oral corticosteroids while on this medication. Report any of these symptoms to your provider immediately.

• Increased Bleeding Risk with Warfarin (Coumadin): Combining zafirlukast (Accolate) with the anticoagulant warfarin (Coumadin) can heighten bleeding risks. Inform the healthcare provider managing your blood thinner treatment about your use of zafirlukast (Accolate) so they can monitor your bleeding risk and adjust your warfarin (Coumadin) dosage as necessary.

Contraindications

• Individuals with liver conditions, including cirrhosis, should not use this medication due to significant health risks. Consult your healthcare provider if this applies to you.

This medication may cause a range of side effects, which vary in severity. Common side effects include headaches, which affect about 13% of users. Other mild side effects such as nausea, vomiting, diarrhea, stomach pain, general discomfort, muscle or back pain, dizziness, weakness, and fever have also been reported. While these symptoms are usually mild, you should consult your healthcare provider if they persist or become bothersome.

Infections and symptoms associated with high white blood cell levels, such as intense itching, rash, or breathing difficulties, require prompt attention. More serious side effects, though rare, necessitate immediate medical care. These include mental or mood changes such as depression, agitation, hallucinations, or thoughts of self-harm. Serious allergic reactions are also possible, with symptoms like trouble breathing, hives, rash, blisters, and swelling of the face, lips, or tongue.

Liver problems are another critical concern. Seek urgent medical help if you experience symptoms such as severe nausea and vomiting, persistent abdominal pain, loss of appetite, yellowing of the skin or eyes, or dark urine, as these could indicate liver damage. Remember, while these severe side effects are rare, being informed allows for prompt action if they occur. Always discuss any new or worsening symptoms with your healthcare provider.