- In clinical trials with montelukast sodium, as detailed by eMedTV.com, the most common side effect in adult participants was headaches, experienced by up to 18 percent of people in some studies. Other side effects experienced by between 2 and 4 percent of participants included abdominal pain, coughing, flu, heartburn and indigestion. Less common side effects in the clinical studies included accidental injury, dental pain, dizziness, fatigue, fever, gastrointestinal infections, nasal congestion, rash and weakness.
- Like adults, children in the clinical studies also experienced coughing, flu, headaches, heartburn and indigestion. Some side effects were different for child participants, however. These included chickenpox, diarrhea, ear infection, eczema, fever, laryngitis, pneumonia, sinus infection, sore throat, tooth infection and vision changes.
- Many other side effects have been reported since montelukast sodium was approved. Some patients have experienced abnormal dreams, bronchitis, drowsiness, insomnia, irritability, muscle aches, muscle cramps, nausea, restlessness, swelling due to fluid retention (edema) and unusual bleeding or bruising.
- Serious side effects call for prompt medical attention. These include hallucinations, depression or a worsening of asthma or allergies. Rarely, people experience an allergic reaction to montelukast sodium. Symptoms are rash or hives, itching, facial or throat swelling and difficulty breathing.
- People with liver disease may not be able to take montelukast sodium because rarely, it can lead to liver damage. Signs include jaundice, dark urine and fatigue. Additionally, chewable montelukast sodium tablets contain phenylalanine, so people with phenylketonuria cannot take this medication.
Clinical Trials
Side Effects in Children
Other Side Effects
Serious Side Effects
Additional Considerations
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