Ciprofloxacin / Fluocinolone Otic Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 27, 2023.

Applies to ciprofloxacin/fluocinolone otic: otic solution.

Important warnings This medicine can cause some serious health issues

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 adverse events

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]

Further information

Ciprofloxacin/fluocinolone otic side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer