What the label lists and what reports show
Ofloxacin side effects
Ofloxacin's FDA label lists its adverse reactions in its own words. FAERS holds 7,263 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 eye pain (348 reports).
- Generic listed
Check it at the source: the ofloxacin FDA label on DailyMed (effective July 18, 2024, Amneal Pharmaceuticals NY LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are some of the possible side effects of ofloxacin otic solution?During the testing of ofloxacin otic solution in external ear infections, the most common side effect was discomfort upon application which happened in 7% of patients. If the pain is severe, the medication should be stopped and you should contact your doctor. Other side effects were: itching (1%), earache (0.8%), and dizziness (0.4%). During testing in middle ear infections, the most common side effect was a bitter taste which happened in 7% of patients with a middle ear infection. This may occur when some of the drops pass from the middle ear to the back of the mouth. This side effect is not serious and there is no need to stop the medicine if this should happen. Other side effects which were found in 1% of the patients were: earache, itching, abnormal sensation, rash and dizziness. Call your doctor about these or other side effects if they occur. […]
Source: FDA drug label, Amneal Pharmaceuticals NY LLC, effective July 18, 2024 (SPL set ba37e2a0-1bf7-41ca-bddd-35fcb77f87de), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsSubjects with Otitis Externa In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with ofloxacin otic solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in two or more of the subjects. Adverse Event Incidence Rate Studies 002/003 † BID (N=229) Studies 016/017 † QD (N=310) Study 020 † QD (N=489) Application Site Reaction 3% 16.8% 0.6% Pruritus 4% 1.2% 1.0% Earache 1% 0.6% 0.8% Dizziness 1% 0.0% 0.6% Headache 0% 0.3% 0.2% Vertigo 1% 0.0% 0.0% † Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative. Study 020 (QD) was open and non-comparative. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Studies 002/003 † BID (N=229) | Studies 016/017 † QD (N=310) | Study 020 † QD (N=489) |
|---|---|---|---|
| Application Site Reaction | 3% | 16.8% | 0.6% |
| Pruritus | 4% | 1.2% | 1.0% |
| Earache | 1% | 0.6% | 0.8% |
| Dizziness | 1% | 0.0% | 0.6% |
| Headache | 0% | 0.3% | 0.2% |
| Vertigo | 1% | 0.0% | 0.0% |
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, Amneal Pharmaceuticals NY LLC, effective July 18, 2024 (SPL set ba37e2a0-1bf7-41ca-bddd-35fcb77f87de), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,263 reports list ofloxacin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 608 are coded as a death and 2,671 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, 8 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?
- Ofloxacin: 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