Side Effects of Ofloxacin Otic Drops
Ofloxacin otic drops are very well tolerated with an overall low incidence of adverse events, most of which are mild and self-limited. 1
Most Common Side Effects to Monitor
Frequent (5-7% of patients)
- Pruritus (itching): Occurs in approximately 5-7% of patients and is the most common side effect 1
- Bitter taste: Affects approximately 7% of patients, particularly those with non-intact tympanic membranes (perforated eardrums or tympanostomy tubes), as drops can pass from the middle ear to the back of the mouth 2, 3
- Application site discomfort: Reported in about 7% of patients during instillation 2, 4
Less Common (1-5% of patients)
- Site reactions: Occur in 4-5% of patients 1
- Earache (otalgia): Affects approximately 0.8-1% of patients 2, 4
- Dizziness: Reported in 0.4-1% of patients 2, 4
Rare (<2% of patients)
Serious Side Effects Requiring Immediate Action
Severe Pain or Allergic Reactions
- If severe pain occurs upon application, stop the medication immediately and contact your doctor 2
- If a rash or allergic reaction develops, discontinue use and contact your doctor immediately 2
Fungal Superinfection (Otomycosis)
- Prolonged use beyond 10 days increases risk of fungal overgrowth in the ear canal 1, 5
- While not reported in randomized trials, otomycosis has been described anecdotally following topical ofloxacin therapy 1
- Limit treatment to a single course of no more than 10 days to prevent this complication 1, 5
Important Safety Considerations
Contact Dermatitis
- Contact dermatitis is a potential complication but is rare after a single course of therapy 1
Ototoxicity
- Unlike aminoglycoside-containing eardrops, ofloxacin is NOT ototoxic 3, 6
- No ototoxicity has been detected in clinical studies or animal studies, even at concentrations higher than 0.3% 3, 6
- This is a major safety advantage over neomycin-containing preparations 3
Systemic Absorption
- Systemic absorption after topical otic administration is minimal 3, 6
- This explains the low incidence of systemic side effects compared to oral fluoroquinolones 3
When to Seek Medical Attention
Contact your doctor if:
- Pain becomes severe during or after application 2
- Symptoms do not improve after 7 days of treatment 2
- New symptoms develop, including rash, severe itching, or swelling 2
- You experience two or more episodes of drainage within 6 months 2
Critical Safety Note
Do NOT take ofloxacin otic solution by mouth 2. If accidentally swallowed or an overdose occurs, call your doctor immediately 2.