Adverse drug reactions from clinical trials and/or spontaneous or literature reports are listed as follows, by system organ class in MedDra. Within each system organ class, the adverse drug reactions are ranked by frequency with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each adverse drug reaction: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), including isolated reports.
Infections and Infestations: Very Rare: Pustular rash.
Immune System Disorders: Very Rare: Hypersensitivity (including urticaria), angioedema.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Asthma.
Skin and Subcutaneous Tissue Disorders: Common: Dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus. Rare: Bullous dermatitis. Very Rare: Photosensitivity reaction.