Herbesser R 100/Herbesser R 200 Adverse Reactions

Adverse reactions to Herbesser R100/R200 were reported in 74 (2.1%) of 3577 patients treated. The most frequently observed adverse reactions were cardiovascular system 0.7% (bradycardia 0.2%, atrioventricular block 0.1%, facial hot flushes 0.1%, etc), gastrointestinal system 0.6% (constipation 0.2%, vomiting 0.2%, stomach discomfort 0.1%, etc), headache/dull headache 0.4%, hypersensitivity 0.3%, etc (at the end of the re-examination period).
Clinically Significant Adverse Reactions: (Rarely: <0.1%; Unknown: Incidence of adverse reactions on the basis of spontaneous reports is unknown).
Since complete atrioventricular block, advanced bradycardia (initial symptoms are bradycardia, dizziness, lightheadedness, etc) may occur rarely. If any abnormalities are observed, Herbesser R 100/R 200 should be discontinued and appropriate measures eg, administration of atropine sulfate, isoproterenol, etc or application of cardiac pacing, etc, if necessary, can be taken.
Congestive heart failure may occur. If any abnormalities are observed, Herbesser R 100/R 200 should be discontinued and appropriate measures eg, administration of cardiac stimulants be 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, Herbesser R 100/R 200 should be discontinued and appropriate measures taken.
Other Adverse Reactions: If any adverse reactions are observed, appropriate measures eg, discontinuing administration, should be taken. See Table 2.

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