What the label lists and what reports show
Clotrimazole side effects
Clotrimazole's FDA label lists its adverse reactions in its own words. FAERS holds 12,230 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 nausea (857 reports).
- Generic listed
Check it at the source: the clotrimazole FDA label on DailyMed (effective January 30, 2026, Glenmark Pharmaceuticals Inc., USA); 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 CLOTIC?The most common side effects of CLOTIC include: headache application site pain ruptured eardrum (perforation of the tympanic membrane) ringing in your ears (tinnitus) tingling, tickling or a burning sensation (paresthesia) These are not all the possible side effects of CLOTIC. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Source: FDA drug label (CLOTIC (clotrimazole) otic solution), Carwin Pharmaceutical Associates, LLC, effective March 3, 2026 (SPL set ef0658c3-9c6b-4705-89d8-cf0644c80fcb), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following adverse reactions have been reported in connection with the use of this product: erythema, stinging, blistering, peeling, edema, pruritis, urticaria, burning, and general irritation of the skin.
Table 1: Selected Adverse Reactions Occurring in 1 or more Patients in Trials 1 and 2
This table is printed in the CLOTIC (clotrimazole) otic solution label published by Carwin Pharmaceutical Associates, LLC of March 3, 2026; the label quoted above does not print one.
| Adverse Reactions | CLOTIC N=261 n (%) | Placebo N=132 n (%) |
|---|---|---|
| Headache | 4 (1.5) | 2 (1.5) |
| Application site pain | 2 (0.8) | 0 |
| Tinnitus | 2 (0.8) | 0 |
| Tympanic membrane perforation | 2 (0.8) | 1 (0.8) |
| Paresthesia | 1 (0.4) | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective January 30, 2026 (SPL set f6898117-14f3-42d2-bc0e-d296add3ad70), via openFDA; the full label on DailyMed
What do FAERS reports show?
12,230 reports list clotrimazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,002 are coded as a death and 4,191 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 21 reactions below, 2 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?
- Clotrimazole: 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