Side Effects of Otic Antibiotic Drops Containing Dexamethasone or Fluocinolone
Otic antibiotic drops containing dexamethasone or fluocinolone are generally safe and well-tolerated, with most side effects being mild and localized to the ear, occurring in less than 5% of patients. 1
Common Side Effects (Occur in 0.4-7% of Patients)
The FDA-approved labeling for ciprofloxacin/dexamethasone identifies the following most common adverse reactions 1:
- Ear itching (pruritus): 1.5-7% of patients 1
- Ear discomfort: 0.4-5% of patients 1
- Ear pain: 0.4% of patients 1
- Application site reactions: 4-5% of patients 1
- Bitter taste: 5% of patients (primarily in those with non-intact tympanic membranes) 2
- Ear debris: 0.6% of patients 1
- Ear congestion: 0.4% of patients 1
- Erythema: 0.4% of patients 1
Less Common Side Effects (Occur in <2% of Patients)
The following adverse events occur rarely 2, 1:
- Rash
- Dizziness
- Vertigo
- Reduced hearing
- Ear discomfort or tingling
- Decreased hearing
Serious but Rare Side Effects
Hypersensitivity Reactions
Stop the medication immediately and seek emergency care if any signs of allergic reaction develop 1:
- Hives (urticaria) 1
- Swelling of face, lips, mouth, or tongue 1
- Rash or itching 1
- Trouble breathing 1
- Dizziness, fast heartbeat, or pounding in chest 1
While serious hypersensitivity reactions including anaphylaxis have been reported with systemic quinolones, these are extremely rare with topical otic preparations due to minimal systemic absorption 1
Superinfection Risk
- Fungal external otitis (otomycosis) can develop with prolonged use, though this was not reported in randomized trials 2, 1
- Superimposed ear infection occurs in 0.6% of patients 1
- The American Academy of Otolaryngology-Head and Neck Surgery recommends limiting treatment to a single course of no more than 10 days to prevent fungal overgrowth 3, 2, 4
Postmarketing Adverse Reactions
The following have been reported voluntarily after market approval 1:
- Auricular swelling
- Headache
- Otorrhea
- Skin exfoliation
- Erythematous rash
- Vomiting
Comparative Safety: Fluocinolone vs. Dexamethasone
Ciprofloxacin plus fluocinolone demonstrates a similar safety profile to ciprofloxacin plus dexamethasone 5:
- Only 3.1% of patients receiving ciprofloxacin/fluocinolone experienced adverse events related to study medication 5
- This compares favorably to 3.6% with ciprofloxacin alone and 4.7% with fluocinolone alone 5
- Both steroid-containing combinations are well-tolerated in children 5
Critical Safety Advantages Over Oral Antibiotics
Topical otic drops have significantly fewer systemic side effects compared to oral antibiotics 6:
- Oral amoxicillin/clavulanic acid causes diarrhea in 19.5% of patients, dermatitis in 7.3%, and gastroenteritis in 4.9% 6
- Topical ciprofloxacin/dexamethasone causes ear pain in only 5.1% of patients 6
Important Safety Considerations
Contraindications
Do not use these drops if 1:
- Allergic to ciprofloxacin, quinolones, or any ingredients
- Viral ear canal infections (including herpes simplex)
- Fungal ear infections
Lack of Ototoxicity
Unlike aminoglycoside-containing drops, fluoroquinolone/steroid combinations are not ototoxic and are safe for use with non-intact tympanic membranes 4, 7, 8. The American Academy of Otolaryngology-Head and Neck Surgery specifically recommends quinolone eardrops as the preferred topical treatment due to their lack of ototoxicity 4
When to Contact Your Doctor
Call your physician if 1:
- Symptoms do not improve after 7 days of treatment
- Fluid continues to drain from the ear after completing treatment
- Fluid drains from the ear 2 or more times within 6 months after stopping treatment
Pregnancy and Breastfeeding
Due to minimal systemic absorption with topical otic administration, ciprofloxacin/dexamethasone is expected to be of minimal risk for maternal and fetal toxicity, though specific data in pregnant women are lacking 1