Includes drug eruption, erythema, erythema multiforme, erythrosis, exfoliative rash, fungal rash, generalised erythema, genital rash, heat rash, milia, rash, rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, skin exfoliation, skin irritation, and urticaria vesiculosa. b Excludes gastrointestinal bleeding and CNS bleeding; these ADRs are reported under the gastrointestinal disorders system organ class and the nervous system disorders system organ class, respectively. c Includes auricular swelling, conjunctival oedema, eye oedema, eye swelling, eyelid oedema, face oedema, gravitational oedema, lip oedema, localised oedema, macular oedema, oedema genital, oedema mouth, oedema peripheral, orbital oedema, penile oedema, periorbital oedema, pitting oedema, scrotal oedema, swelling face, and tongue oedema.