Duac Adverse Reactions

Adverse drug reactions (ADRs) are summarised as follows for Duac Once Daily Gel as a combination including any additional ADRs that have been reported for the single topical active ingredients, benzoyl peroxide or clindamycin. Adverse drug reactions are listed by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1,000 and <1/100); rare (≥1/10,000 and <1/1,000) and not known (cannot be estimated from the available data). (See Table 2.)

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In addition to the ADRs reported in the table as previously mentioned, in the pivotal trial conducted with topical clindamycin 1%/benzoyl peroxide 3% gel, application site photosensitivity reaction was also reported commonly.
Also in addition to the ADRs reported as previously mentioned, in studies conducted with topical clindamycin alone, headache and application site pain were reported commonly.
Local Tolerability: During the five clinical trials with Duac Once Daily Gel, all patients were graded for facial erythema, peeling, burning, and dryness on the following scale: 0 = absent, 1 = mild, 2 = moderate and 3 = severe. The percentage of patients that had symptoms present before treatment (at baseline) and during treatment were as follows: (See Table 3.)

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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the National Centre for Adverse Drug Reaction Monitoring, National Pharmaceutical Control Bureau (NPCB).