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Otovel Side Effects

Generic name: ciprofloxacin / fluocinolone otic

Medically reviewed by Drugs.com. Last updated on July 24, 2020.

Note: This document contains side effect information about ciprofloxacin / fluocinolone otic. Some of the dosage forms listed on this page may not apply to the brand name Otovel.

For the Consumer

Applies to ciprofloxacin/fluocinolone otic: otic solution

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Dizziness or passing out.
  • Fast or abnormal heartbeat.
  • Change in balance.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Fluid draining from the ear.
  • Ear irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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]

References

1. "Product Information. Otovel (ciprofloxacin-fluocinolone otic)." Arbor Pharmaceuticals, Atlanta, GA.

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

More about Otovel (ciprofloxacin / fluocinolone otic)

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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.