Skip to main content

Otovel Side Effects

Generic name: ciprofloxacin / fluocinolone otic

Medically reviewed by Drugs.com. Last updated on Jun 18, 2022.

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:

  • the first sign of any skin rash, no matter how mild;

  • new or worsening symptoms of infection; or

  • ear drainage that continues for up to 6 months after you have finished all doses of this medicine.

Common side effects may include:

  • ear pain, swelling, or itching;

  • problems with balance; or

  • 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]

More about Otovel (ciprofloxacin / fluocinolone otic)

Patient resources

Professional resources

Related treatment guides

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Otovel (ciprofloxacin-fluocinolone otic)." Arbor Pharmaceuticals (2016):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.