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Ciprofloxacin / fluocinolone otic Side Effects

Medically reviewed by Last updated on Feb 5, 2023.

Applies to ciprofloxacin/fluocinolone otic: otic solution.


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.


The most commonly reported side effects are otorrhea and the development of excessive granulation tissue.[Ref]


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


Common (1% to 10%): Otorrhea, ear infection

Uncommon (0.1% to 1%): Ear pruritus, auricular swelling


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


Frequency not reported: Loss of consciousness[Ref]


Common (1% to 10%): Excessive granulation tissue

Uncommon (0.1% to 1%): Exanthematous rash, rash, skin exfoliation


Frequency not reported: Facial edema, itching, urticaria


Uncommon (0.1% to 1%): Excessive granulation tissue[Ref]


Uncommon (0.1% to 1%): Flushing


Frequency not reported: Cardiovascular collapse[Ref]


Uncommon (0.1% to 1%): Medication residue[Ref]


Uncommon (0.1% to 1%): Vomiting[Ref]


Uncommon (0.1% to 1%): Irritability[Ref]


Uncommon (0.1% to 1%): Candidiasis[Ref]



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]


Postmarketing reports: Allergic reaction


Frequency not reported: Angioedema, fatal anaphylactic/hypersensitivity reactions[Ref]


Frequency not reported: Blurred vision[Ref]



Frequency not reported: Airway obstruction, dyspnea, laryngeal edema, pharyngeal edema[Ref]


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.