What the label lists and what reports show
Betamethasone and clotrimazole side effects
Betamethasone and clotrimazole's FDA label: “Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients.” FAERS holds 428 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 chronic kidney disease (55 reports).
- Generic listed
Check it at the source: the betamethasone and clotrimazole FDA label on DailyMed (effective July 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 clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base)?Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) may cause serious side effects, including: • Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) can pass through your skin. Too much clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) passing through your skin can cause your adrenal glands to stop working. Your healthcare provider may do blood tests to check for adrenal gland problems. • Vision problems. Topical corticosteroids may increase your chance of developing cataracts and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base). The most common side effects of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) include burning, tingling, rash, swelling, and infections. […]
Source: FDA drug label, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective July 28, 2026 (SPL set 55db730a-df6d-4950-9c26-91b06bdcef36), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions reported for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients.
From the label: adverse reactions, continuedMost common adverse reactions reported for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials common adverse reaction reported for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) was paresthesia in 1.9% of patients. Adverse reactions reported at a frequency < 1% included rash, edema, and secondary infection. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. …
Source: FDA drug label, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective July 28, 2026 (SPL set 55db730a-df6d-4950-9c26-91b06bdcef36), via openFDA; the full label on DailyMed
What do FAERS reports show?
428 reports list betamethasone and clotrimazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 34 are coded as a death and 105 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 20 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.
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?
- Betamethasone and 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