Note: This document contains side effect information about ciprofloxacin / fluocinolone otic. Some dosage forms listed on this page may not apply to the brand name Otovel.
Applies to ciprofloxacin/fluocinolone otic: otic solution.
Warning
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Get emergency medical help if you have signs of an allergic reaction: hives, rash, itching; dizziness; fast or pounding heartbeat; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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the first sign of any skin rash, no matter how mild;
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new or worsening symptoms of infection; or
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ear drainage that continues for up to 6 months after you have finished all doses of this medicine.
Common side effects may include:
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ear pain, swelling, or itching;
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problems with balance; or
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scar tissue on part of the ear.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to ciprofloxacin/fluocinolone otic: otic solution.
General
The most commonly reported side effects are otorrhea and the development of excessive granulation tissue.[Ref]
Other
Common (1% to 10%): Ear discomfort, ear pain, ear pruritus, otorrhea
Uncommon (0.1% to 1%): Auricular swelling, contralateral otitis media, crying, device occlusion (tympanostomy tube obstruction), ear congestion, ear infection/fungal ear infection, fatigue, hypoacusis, tinnitus, tympanic membrane disorder
Ciprofloxacin:
Common (1% to 10%): Otorrhea, ear infection
Uncommon (0.1% to 1%): Ear pruritus, auricular swelling
Fluocinolone:
Common (1% to 10%): Otorrhea
Uncommon (0.1% to 1%): Ear infection[Ref]
Nervous system
Common (1% to 10%): Dysgeusia
Uncommon (0.1% to 1%): Balance disorder, paresthesia/tingling in ears, dizziness, headache
Ciprofloxacin:
Frequency not reported: Loss of consciousness[Ref]
Dermatologic
Common (1% to 10%): Excessive granulation tissue
Uncommon (0.1% to 1%): Exanthematous rash, rash, skin exfoliation
Ciprofloxacin:
Frequency not reported: Facial edema, itching, urticaria
Fluocinolone:
Uncommon (0.1% to 1%): Excessive granulation tissue[Ref]
Cardiovascular
Uncommon (0.1% to 1%): Flushing
Ciprofloxacin:
Frequency not reported: Cardiovascular collapse[Ref]
Local
Uncommon (0.1% to 1%): Medication residue[Ref]
Gastrointestinal
Uncommon (0.1% to 1%): Vomiting[Ref]
Psychiatric
Uncommon (0.1% to 1%): Irritability[Ref]
Immunologic
Uncommon (0.1% to 1%): Candidiasis[Ref]
Musculoskeletal
Ciprofloxacin:
Frequency not reported: Achilles, hand, other tendon, or shoulder rupture[Ref]
Patients given systemic fluoroquinolones have reported tendon rupture requiring surgery and/or resulting in prolonged disability. Risk of tendon rupture may be higher in those receiving corticosteroids concomitantly, especially in older patients and in high-stress tendons. It is unknown whether otic formulations are associated with an increased risk of tendon rupture.[Ref]
Hypersensitivity
Postmarketing reports: Allergic reaction
Ciprofloxacin:
Frequency not reported: Angioedema, fatal anaphylactic/hypersensitivity reactions[Ref]
Ocular
Frequency not reported: Blurred vision[Ref]
Respiratory
Ciprofloxacin:
Frequency not reported: Airway obstruction, dyspnea, laryngeal edema, pharyngeal edema[Ref]
