Montelukast has been evaluated for safety in approximately 2950 adult and adolescent patients 15 years of age and older in clinical trials. In placebo-controlled clinical trials, the following adverse experiences reported with Montelukast (M) occurred in greater than or equal to 1% of patients and at an incidence greater than that in patients treated with placebo (P), regardless of causality assessment: Body As A Whole:
Asthenia/fatigue M (1.8%), P (1.2%). Fever: M (0.6%), P (3.0%). Abdominal Pain: M (2.9%), P (2.5%) Trauma: M (1.0%), P (0.8%).
Digestive System Disorders:
Dyspepsia M (2.1%), P (1.1%). Infectious gastroenteritis: M (2.1%), P (1.1%). Dental Pain: M (1.7%), P (1.0%).
Dizziness M (1.9%), P (1.4%). Headache: M (18.4%), P (18.1%).
Respiratory System Disorders:
Congestion, nasal M (1.6%), P (1.3%). Cough M (2.7%), P (2.4%). Influenza: M (4.2%), P (3.9%).
Skin/Skin Appendages Disorder:
Rash M (1.6%), P (1.2%).
Laboratory Adverse Experiences:
* ALT increased M (2.1%), P (2.0%). AST increased M (1.6%), P (1.2%). Pyuria: M (1.0%), P (0.9%).
In therapeutic studies in women and men aged 12 to 71 years, 15.1% of the patients in the Levocetirizine 5 mg group had at least one adverse drug reaction compared to 11.3% in the placebo group. 91.6 % of these adverse drug reactions were mild to moderate.
In therapeutic trials, the drop out rate due to adverse events was 1.0% (9/935) with Levocetirizine 5 mg and 1.8% (14/771) with placebo. Clinical therapeutic trials with Levocetirizine included 935 subjects exposed to the drug at the recommended dose of 5 mg daily. From this data, the following adverse drug reactions were reported at rates of 1 % or greater during treatment with Levocetirizine 5 mg (L) or placebo (P): Headache:
L (2.6%), P (3.2%).
L (5.2%), P (1.4%).
L (2.6%), P (1.6%).
L (2.5%), P (1.2%).
Further uncommon incidences of adverse reactions like asthenia or abdominal pain were observed. The incidence of sedating adverse drug reactions such as somnolence, fatigue, and asthenia was altogether more common (8.1 %) with Levocetirizine 5 mg than with placebo (3.1%). In addition to the adverse reactions reported during clinical studies and listed previously, very rare cases of the following adverse drug reactions have been reported in post-marketing experience: Immune system disorders:
hypersensitivity including anaphylaxis.
Nervous system disorders:
Respiratory, thoracic, and mediastinal disorders:
Skin and subcutaneous tissue disorders:
angioneurotic edema, fixed drug eruption, pruritus, rash, urticaria.
Musculoskeletal, connective tissues, and bone disorders:
weight gain, abnormal liver function tests.