What the label lists and what reports show
Ketoconazole side effects
Ketoconazole's FDA label lists its adverse reactions in its own words. FAERS holds 17,282 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pruritus (984 reports).
- Generic listed
Check it at the source: the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ketoconazole tablets?Ketoconazole tablets may cause serious side effects, including: See "What is the most important information I should know about ketoconazole tablets?" adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Ketoconazole tablets may cause adrenal insufficiency if you take a high dose. Your healthcare provider will follow you closely if you have adrenal insufficiency or if you are taking prednisone or other similar medicines for long periods of time. Call your healthcare provider right away if you have symptoms of adrenal insufficiency such as tiredness, weakness, dizziness, nausea, and vomiting. serious allergic reactions. Some people can have a serious allergic reaction to ketoconazole tablets. […]
Source: FDA drug label (KETOCONAZOLE), Strides Pharma Science Limited, effective December 17, 2025 (SPL set 6d4be760-c723-4f54-a854-12c61cf91703), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsDuring clinical trials 45 (5.0%) of 905 patients treated with Ketoconazole Cream 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with Ketoconazole Cream developed a painful allergic reaction. In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with Ketoconazole Cream or one of its excipients, namely sodium sulfite or propylene glycol.
Source: FDA drug label, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set cad7c647-34a9-4e4e-83b3-8d78e58f588f), via openFDA; the full label on DailyMed
What do FAERS reports show?
17,282 reports list ketoconazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,119 are coded as a death and 3,823 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ketoconazole: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions