Adverse reactions to HERBESSER and HERBESSER 60 were reported in 442 (4.6%) of 9,630 patients treated. The most frequent adverse reactions were observed in gastrointestinal system 1.4% (stomach discomfort 0.2%, constipation 0.2%, abdominal pain 0.1%, etc.), and in cardiovascular system 1.4% (dizziness 0.5%, bradycardia 0.4%, facial hot flushes 0.2%, atrioventricular block 0.2%, etc.), hypersensitivity 1.2%, headache 0.2%, etc. (Data collected from the time of approval up to December 1990).
Clinically significant adverse reactions (rarely: <0.1%, unknown: the incidence of adverse reactions on the basis of spontaneous reports is unknown.)
Complete atrioventricular block, severe bradycardla (initial symptoms: bradycardia, dizziness, light headed, etc.), etc., may occur rarely (<0.1%). If any abnormalities are observed, the drug should be discontinued and appropriate measures, such as administration of atropine sulfate, isoproterenol, etc., and/or application of cardiac pacing, etc. if necessary, taken.
Congestive heart failure* may occur. If any abnormalities are observed, the drug should be discontinued and appropriate measures, such as administration of cardiac stimulants, taken.
Mucocutaneous-ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), erythroderma (exfoliative dermatitis)*, etc. may occur. If erythema, blisters, pruritus, fever, enanthema, etc. are observed, the drug should be discontinued and appropriate measures taken.
Other adverse reactions: If any adverse reactions are observed, appropriate measures, such as discontinuing administrationm should be taken. (See Table 2.)
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