Adverse drug reactions reported among 834 patients who received miconazole nitrate 2% cream (n=426) and/or placebo cream base (n=408) in 21 double-blind clinical trials are presented in Table 1 below. Moreover, adverse drug reactions from spontaneous reports during the worldwide post-marketing experience with Daktarin that meet threshold criteria are included in Table 1. The adverse drug reactions are ranked by frequency, using the following convention:
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
Very rare <1/10,000, including isolated reports
Adverse reactions obtained from clinical studies and post-marketing surveillance are presented by frequency category based on incidence in clinical trials or epidemiology studies, when known.
Table 1: Adverse reactions in clinical trials and post-marketing experience
System Organ Class
|
Adverse Reactions
|
Frequency Category
|
Uncommon
(≥1/1,000 to <1/100)
|
Not known
|
Immune System Disorders
|
|
Anaphylactic reaction
Hypersensitivity
|
Skin and Subcutaneous Tissue Disorders
|
Skin burning sensation
Skin inflammation
Skin hypopigmentation
|
Angioedema
Urticaria
Contact dermatitis
Rash
Erythema
Pruritus
|
General Disorders and Administration Site Conditions
|
Application site irritation
Application site burning
Application site pruritus
Application site reaction NOS
Application site warmth
|
|
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 via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.