Fixed drug eruption (FDE) is a specific cutaneous adverse reaction induced by an ever-expanding list of drugs. It usually consists of solitary or multiple lesions occurring after the drug exposure.

We describe a patient with a FDE induced by bromhexine.

A 49-year-old man was treated with the bromhexine+tetracycline association (Bronchocine*) for acute cough. Two weeks later, the patient complained for very pruritic erythematous and violaceous plaques located on the trunk and upper limbs, he had no other symptoms. The association (bromhexine+tetracycline) was withdrawn and skin lesions were resolved spontaneously with residual hyperpigmentation. 2 months later, the patient reported that the lesions became inflamed and very pruritic nearly one day after bromhexine (Bisolvan*) intake for the same respiratory symptom. Bromhexine was withdrawn and lesions resolved after topical corticosteroid. Skin biopsy showed hyperplasia of the epidermis with multiple necrotic keratinocytes. A lymphohistiocytic inflammatory infiltrate with many neutrophils and eosinophils with melanotic blocks in the superficial derma. Patch test performed with bromhexine applied on lesional skin was positive and negative with tetracycline. Based on the clinical pattern, patch-tests result and histopathologic findings, the diagnostic of FDE due to bromhexine was retained and the patient was advised to avoid it. According to the French causality assessment method updated, the causal relationship between adverse event and bromhexine was “I6”.

Bromhexine was used in treatment of many respiratory symptoms. In literature, dermatologic adverse reactions related to bromhexine include urticaria, angioedema, and anaphylaxis [1van Riemsdijk M.M., van der Klauw M.M., Stricker B.H., Herings R.M. Skin reactions attributed to the use of bromhexine Ned Tijdschr Geneeskd 1994 ;  138 (49) : 2446-2448

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Physicians should be aware that bromhexine could induce serious skin reaction.