Applies to ciprofloxacin/dexamethasone otic: otic suspension.

Serious side effects

Along with its needed effects, ciprofloxacin/dexamethasone otic may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ciprofloxacin / dexamethasone otic:

Incidence not known

• Cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest
• unusual tiredness or weakness

Other side effects

Some side effects of ciprofloxacin / dexamethasone otic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Ear discomfort
• ear pain
• itching skin on the ear

Rare

• Bitter, sour, or unusual taste in the mouth
• ear congestion
• ear debris
• ear residue
• redness of the skin
• superimposed ear infection (second ear infection)

For Healthcare Professionals

Applies to ciprofloxacin / dexamethasone otic: otic suspension.

General

The most commonly reported side effects in patients with tympanostomy tubes and acute otitis media were ear pain, discomfort, and dysgeusia/tasting medicine.

The most commonly reported side effect in patients with acute otitis externa was ear pruritus.^[Ref]

Other

Common (1% to 10%): Ear discomfort, ear pain, ear pruritus

Uncommon (0.1% to 1%): Otorrhea, fatigue, ear congestion, candidiasis/fungal ear infection, crying, superimposed ear infection, device/tympanostomy tube blockage/occlusion, ear precipitate/residue/debris/medication residue present

Rare (0.01% to 0.1%): Hypoacusis, tinnitus

Frequency not reported: decreased hearing, ear disorder

Postmarketing reports: Auricular swelling^[Ref]

Nervous system

Uncommon (0.1% to 1%): Taste perversion/dysgeusia, paresthesia/tingling in ears

Rare (0.01% to 0.1%): Dizziness, headache^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Erythema, flushing

Rare (0.01% to 0.1%): Rash erythematous

Postmarketing reports: Skin exfoliation^[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Vomiting

Frequency not reported: Oral moniliasis^[Ref]

Psychiatric

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

Hypersensitivity

Postmarketing reports: Hypersensitivity^[Ref]