Daktarin Oral Gel Adverse Reactions

The safety of Daktarin Oral Gel was evaluated in 88 adult patients with oral candidiasis or oral mycoses who participated in 1 randomised, active-controlled, double-blind clinical trial and 3 open-label clinical trials. These patients took at least 1 dose of Daktarin Oral Gel and provided safety data.
Adverse drug reactions (ADRs) reported by Daktarin Oral Gel-treated adult patients in the 4 clinical trials are shown in Table 1.

Click on icon to see table/diagram/image

The safety of Daktarin Oral Gel was evaluated in 23 paediatric patients with oral candidiasis who participated in 1 randomised, active-controlled, open-label clinical trial in paediatric patients aged ≤1 month to 10.7 years. These patients took at least 1 dose of Daktarin Oral Gel and provided safety data.
Adverse drug reactions reported for Daktarin Oral Gel-treated paediatric patients in 1 clinical trial is presented in Table 2.

Click on icon to see table/diagram/image

Post-Marketing Experience: ADRs first identified during post-marketing experience with Daktarin Oral Gel are included as follows. Frequencies are provided from spontaneous reporting rates according to the following convention: Very common ≥1/10; common: ≥1/100 and <1/10; uncommon: ≥1/1000 and <1/100; rare: ≥1/10,000 and <1/1000; very rare: <1/10,000 including isolated reports.
Immune System Disorders: Very Rare: Anaphylactic reaction, angioedema, hypersensitivity.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Choking (see Contraindications).
Gastrointestinal Disorders: Very Rare: Diarrhoea, stomatitis, tongue discoloration.
Hepatobiliary Disorders: Very Rare: Hepatitis.
Skin and Subcutaneous Tissue Disorders: Very Rare: Toxic epidermal necrolysis, Stevens-Johnson syndrome, urticaria, rash.