OTOVEL SIDE EFFECTS
- Generic Name: ciprofloxacin and fluocinolone acetonide otic solution
- Brand Name: Otovel
- Drug Class: Antibiotics/Corticosteroids, Otic
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
Hypersensitivity Reactions
Clinical Trials 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, 224 patients with AOMT were treated with OTOVEL for a median duration of 7 days. All the patients received at least one dose of OTOVEL. There were 220 patients who received at least one dose of ciprofloxacin (CIPRO) and 213 patients received at least one dose of fluocinolone acetonide (FLUO).
The most common adverse reactions that occurred in 1 or more patients are as follows:
Table 1: Selected Adverse Reactions that Occurred in 1 or more Patients in the OTOVEL Group
| A Adverse Reactions1 | Number (%) of Patients | ||
| OTOVEL N=224 |
CIPRO N=220 |
FLUO N=213 |
|
| Otorrhea | 12 (5.4%) | 9 (4.1%) | 12 (5.6%) |
| Excessive granulation tissue | 3 (1.3%) | 0 (0.0%) | 2 (0.9%) |
| Ear infection | 2 (0.9%) | 3 (1.4%) | 1 (0.5%) |
| Ear pruritus | 2 (0.9%) | 1 (0.5%) | 1 (0.5%) |
| Tympanic membrane disorder | 2 (0.9%) | 0 (0.0%) | 0 (0.0%) |
| Auricular swelling | 1 (0.4%) | 1 (0.5%) | 0 (0.0%) |
| Balance disorder | 1 (0.4%) | 0 (0.0%) | 0 (0.0%) |
| 1Selected adverse reactions that occurred in ≥ 1 patient in the OTOVEL group derived from all reported adverse events that could be related to the study drug or the drug class. | |||
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of ciprofloxacin and fluocinolone acetonide otic solution, 0.3% / 0.025% outside the US. Because these 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.
- Immune system disorders: allergic reaction.
- Infections and infestations: candidiasis.
- Nervous system disorders: dysgeusia, paresthesia (tingling in ears), dizziness, headache.
- Ear and labyrinth disorders: ear discomfort, hypoacusis, tinnitus, ear congestion.
- Vascular disorders: flushing.
- Skin and subcutaneous tissue disorders: skin exfoliation.
- Injury, poisoning and procedural complications: device occlusion (tympanostomy tube obstruction).
SRC: NLM .