What the label lists and what reports show
Ciprofloxacin and hydrocortisone side effects
Ciprofloxacin and hydrocortisone's FDA label lists its adverse reactions in its own words. FAERS holds 20,676 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 drug hypersensitivity (2,482 reports).
- Generic listed
Check it at the source: the ciprofloxacin and hydrocortisone FDA label on DailyMed (effective May 29, 2026, Sandoz Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsIn Phase 3 clinical trials, a total of 564 patients were treated with ciprofloxacin hydrochloride and hydrocortisone otic suspension. Adverse events with at least remote relationship to treatment included headache (1.2%) and pruritus (0.4%). The following treatment-related adverse events were each reported in a single patient: migraine, hypesthesia, paresthesia, fungal dermatitis, cough, rash, urticaria, and alopecia. The following reactions have been identified during post-approval use of ciprofloxacin hydrochloride and hydrocortisone otic suspension in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. …
Source: FDA drug label, Sandoz Inc, effective May 29, 2026 (SPL set c0881bbe-cc95-45d4-9878-3bc8946eff26), via openFDA; the full label on DailyMed
What do FAERS reports show?
20,676 reports list ciprofloxacin and hydrocortisone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,436 are coded as a death and 6,029 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. Reports rose sharply in 2016 (2,846, against a median of 870 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 23 reactions below, 4 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?
- Ciprofloxacin and hydrocortisone: 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