Quick answers
- What is Ciprofloxacin and dexamethasone used for?
- The FDA-approved label (Ciprofloxacin and Dexamethasone, Sandoz Inc, January 31, 2025) says: “Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Ciprofloxacin and dexamethasone?
- The “Adverse Reactions” section of the FDA label (Ciprofloxacin and Dexamethasone, Sandoz Inc, January 31, 2025) begins: “The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1)] • Potential for Microbial Overgrowth with Prolonged Use [see Warnings and Precautions (5.2)] Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%).” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ciprofloxacin and dexamethasone have a boxed warning?
- No. None of the 13 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ciprofloxacin and dexamethasone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ciprofloxacin and dexamethasone been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started August 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ciprofloxacin and dexamethasone?
- 14 companies list prescription products of Ciprofloxacin and dexamethasone in the FDA NDC Directory, including Redpharm Drug, NorthStar RxLLC and Armas Pharmaceuticals Inc.
What Ciprofloxacin and dexamethasone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below …
— FDA label: Ciprofloxacin and Dexamethasone, Sandoz Inc, effective January 31, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (suspension/ drops, auricular (otic)), Ciprofloxacin and Dexamethasone, Sandoz Inc; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 13 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 13 FDA labels for this medicine have a boxed warning.
Ciprofloxacin and dexamethasone side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following serious adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
- Potential for Microbial Overgrowth with Prolonged Use [see Warnings and Precautions (5.2)] Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%).
Read more of this section
(6) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phases II and III clinical trials, a total of 937 patients were treated with ciprofloxacin and dexamethasone otic suspension. This included 400 patients with acute otitis media with tympanostomy tubes (AOMT) and 537 patients with AOE. The reported adverse reactions are listed below: Acute Otitis Media in Pediatric Patients with Tympanostomy Tubes The following adverse reactions occurred in 0.5% or more of the patients with non-intact tympanic membranes. Adverse Reactions Incidence (N = 400) Ear discomfort 3.0% Ear pain 2.3% Ear precipitate (residue) 0.5% Irritability 0.5% Taste Perversion 0.5% The following adverse reactions were each reported in a single patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis; crying; dizziness; and erythema. Acute Otitis Externa The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic membranes. Adverse Reactions Incidence (N = 537) Ear pruritus 1.5% Ear debris 0.6% Superimposed ear infection 0.6% Ear congestion 0.4% Ear pain 0.4% Erythema 0.4% The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling). 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of ciprofloxacin and dexamethasone otic suspension. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include auricular swelling, headache, hypersensitivity, otorrhea, skin exfoliation, rash erythematous, and vomiting.
Table from the label
| Adverse Reactions | Incidence (N = 400) |
|---|---|
| Ear discomfort | 3.0% |
| Ear pain | 2.3% |
| Ear precipitate (residue) | 0.5% |
| Irritability | 0.5% |
| Taste Perversion | 0.5% |
— FDA label: Ciprofloxacin and Dexamethasone, Sandoz Inc, effective January 31, 2025. This is part of the section. Read the full label on DailyMed →
Ciprofloxacin and dexamethasone dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Ciprofloxacin and dexamethasone otic suspension is for otic use (ears) only, not for ophthalmic use, or for injection. (2.1)
- Shake well immediately before use. (2.1)
- Instill four drops into the affected ear twice daily, for seven days. (2.2) 2.1 Important Administration Instructions
- Ciprofloxacin and dexamethasone otic suspension is for otic use (ears) only, and not for ophthalmic use, or for injection.
Read more of this section
- Shake well immediately before use. 2.2 Dosage For the Treatment of Acute Otitis Media in Pediatric Patients (age 6 months and older) With Tympanostomy Tubes The recommended dosage regimen through tympanostomy tubes is as follows:
- Four drops [equivalent to 0.14 mL of ciprofloxacin and dexamethasone otic suspension, (consisting of 0.42 mg of ciprofloxacin and 0.14 mg of dexamethasone)] instilled into the affected ear twice daily for seven days.
- The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension.
- The patient should lie with the affected ear upward, and then the drops should be instilled.
- The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear.
- This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear.
- Discard unused portion after therapy is completed. For the Treatment of Acute Otitis Externa (age 6 months and older) The recommended dosage regimen is as follows:
- Four drops [equivalent to 0.14 mL of ciprofloxacin and dexamethasone otic suspension, (consisting of 0.42 mg ciprofloxacin and 0.14 mg dexamethasone)] instilled into the affected ear twice daily for seven days.
- The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension.
- The patient should lie with the affected ear upward, and then the drops should be instilled.
- This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
- Discard unused portion after therapy is completed.
— FDA label: Ciprofloxacin and Dexamethasone, Sandoz Inc, effective January 31, 2025. Read the full label on DailyMed →
Ciprofloxacin and dexamethasone in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary There are no available data on ciprofloxacin and dexamethasone otic suspension use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal, or fetal outcomes.
Read more of this section
Because of the minimal systemic absorption of ciprofloxacin and dexamethasone following topical otic administration of ciprofloxacin and dexamethasone otic suspension, this product is expected to be of minimal risk for maternal and fetal toxicity when administered to pregnant women [see Clinical Pharmacology (12.3)]. Animal reproduction studies have not been conducted with ciprofloxacin and dexamethasone otic suspension. Oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal malformations (see Data). These doses were at least 200 times the recommended otic human dose (ROHD in mice, rats, and rabbits, respectively, based on body surface area (BSA). With dexamethasone, malformations have been observed in animal studies after ocular and systemic administration. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and of miscarriage is 15% to 20%, respectively. Data Animal Data Ciprofloxacin Developmental toxicology studies have been performed with ciprofloxacin in rats, mice, and rabbits. The doses used in these studies are, at a minimum, approximately 200 times greater than the recommended otic human dose based on body surface area. In rats and mice, oral doses up to 100 mg/kg administered during organogenesis (Gestation Days [GD], 6-17) were not associated with adverse developmental outcomes, including embryofetal toxicity or malformations. A 30 mg/kg oral dose was associated with suppression of maternal and fetal body weight gain, but fetal malformations were not observed. Intravenous administration of doses up to 20 mg/kg to pregnant rabbits was not maternally toxic and neither embryo-fetal toxicity nor fetal malformations were observed. To mitigate maternal toxicity in these studies, groups of rabbits received ciprofloxacin for a different 5 day dosing period covering organogenesis (GD 6-18). Dexamethasone Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application. In a rat oral developmental toxicity study, no adverse effects were observed at 0.01 mg/kg/day (0.1 times the ROHD based on BSA), although embryotoxicity was observed at higher doses.
— FDA label: Ciprofloxacin and Dexamethasone, Sandoz Inc, effective January 31, 2025. Read the full label on DailyMed →
When Ciprofloxacin and dexamethasone should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
- Ciprofloxacin and dexamethasone otic suspension is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication.
- Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections.
Read more of this section
- Ciprofloxacin and dexamethasone otic suspension is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. (4)
- Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections. (4)
— FDA label: Ciprofloxacin and Dexamethasone, Sandoz Inc, effective January 31, 2025. Read the full label on DailyMed →
Ciprofloxacin and dexamethasone overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Due to the characteristics of this preparation, no toxic effects are to be expected with an otic overdose of this product.
— FDA label: Ciprofloxacin and Dexamethasone, Sandoz Inc, effective January 31, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Suspension/ drops · Suspension |
|---|---|
| Route | Auricular (otic) |
| Prescription products | 15 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ciprofloxacin hydrochloride 3 mg/mL · dexamethasone 1 mg/mL suspension | Generic | $7.17 per mL |
| ciprofloxacin hydrochloride 3 mg/mL · dexamethasone 1 mg/mL suspension/ drops | Generic | $7.17 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Redpharm Drug2 products
- NorthStar RxLLC1 product
- Armas Pharmaceuticals Inc.1 product
- Sandoz Inc1 product
- Sentiss Pharmaceuticals LLC1 product
- Alembic Pharmaceuticals Limited1 product
- Dr. Reddy's Laboratories Inc.1 product
- Alembic Pharmaceuticals Inc.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Sportpharm LLC1 product
- Amneal Pharmaceuticals of New York LLC1 product
- NuCare Pharmaceutical, Inc.1 product
- Upsher-Smith Laboratories, LLC1 product
- NuCare Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021537 CIPRODEX | Sandoz | July 18, 2003 | 6, latest May 27, 2022 2022: Manufacturing (CMC) · 2020: Labeling · 2019: Labeling |
Generic approvals (6)
- ANDA205548DR Reddys · August 10, 2020
- ANDA210470Sun Pharm · August 30, 2022
- ANDA215768Sentiss · June 9, 2023
- ANDA216501Amneal · March 22, 2024
- ANDA216487Upsher Smith Labs · January 6, 2026
- ANDA217723Alembic · October 15, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 13, 2025 · Class II · Ongoing · D-0626-2025
Temperature Abuse
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-6186-67, Carton NDC# 07 — Sandoz Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 403908 |
|---|---|
| SPL set ID of the quoted label | 89fef4d2-7078-47f1-96bf-aca50b135a97 |
| FDA labels (SPL) | 13 |
| FDA applications | NDA021537, 6 ANDA |
| Active ingredients (FDA) | CIPROFLOXACIN / DEXAMETHASONE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Redpharm DrugMaker or distributor
- NorthStar RxLLCMaker or distributor
- Armas Pharmaceuticals Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ciprofloxacin and Dexamethasone, Sandoz Inc, effective January 31, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →