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).
Adverse reactions to Herbesser R100 were reported in 74 (2.1%) of 3,557 patients. The major adverse reactions were cardiovascular symptoms in 0.7% (bradycardia in 0.2%, atrioventricular block in 0.1%, facial flushing in 0.1%, etc.), gastrointestinal symptoms in 0.6% (constipation in 0.2%, nausea in 0.2%, stomach discomfort in 0.1%, etc.), headache and headache dull in 0.4%, hypersensitivity in 0.3%, etc. (at time of completion of reexamination).
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 bradycardia (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 administration, should be taken. (See Table 3.)
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