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Ciprofloxacin / fluocinolone otic Side Effects

Medically reviewed by Last updated on Dec 20, 2020.

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

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, Atlanta, GA.

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.