ciprodex
Pharmaranks rates Ciprodex 3.2/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Ciprodex is a combination medicine containing Ciprofloxacin and Dexamethasone.
Ciprofloxacin and Dexamethasone · by Sandoz
Available as a generic: Ciprofloxacin and Dexamethasone
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Ciprofloxacin and Dexamethasone
- Form
- Drops
- Strength
- Ciprofloxacin 0.3%; Dexamethasone 0.1%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Sandoz
- Half-life
- about 4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$3.71 for 30 — not your price
- FDA application
- NDA021537
What is Ciprodex?
From the FDA label:Ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension contains the quinolone antimicrobial, ciprofloxacin hydrochloride, combined with the corticosteroid, dexamethasone, in a sterile, preserved suspension for otic use. Each mL of ciprofloxacin and dexamethasone otic suspension contains Actives: ciprofloxacin hydrochloride equivalent to 3 mg ciprofloxacin base and 1 mg dexamethasone. Preservative: 0.1 mg benzalkonium chloride. Inactives: acetic acid, boric acid, edetate disodium, hydroxyethyl cellulose, purified water, sodium acetate, sodium chloride, and tyloxapol. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH. Ciprofloxacin, a quinolone antimicrobial is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline carboxylic acid. The empirical formula is C 17 H 18 FN 3 O 3 ·HCl·H 2 O. The molecular weight is 385.82 g/mol and the structural formula is: Dexamethasone, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The empirical formula is C 22 H 29 FO 5 . The molecular weight is 392.46 g/mol and the structural formula is: figure1 figure2
How to use
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. • 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…
Side effects
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%). ( 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…
Warnings
Important safety information
Hypersensitivity and anaphylaxis have been reported with systemic use of quinolones. Discontinue use if this occurs with use of ciprofloxacin and dexamethasone otic suspension. ( 5.1 ) • Prolonged use may result in overgrowth of non-susceptible bacteria and fungi. ( 5.2 ) 5.1 Hypersensitivity Reactions Ciprofloxacin and dexamethasone otic suspension should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal, or facial edema), airway obstruction, dyspnea, urticaria, and itching. 5.2 Potential for Microbial Overgrowth with Prolonged Use Prolonged use of ciprofloxacin and dexamethasone otic suspension may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy. 5.3 Continued or Recurrent Otorrhea If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition, such as cholesteatoma, foreign body, or a tumor.
Who should not take Ciprodex
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. • 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 )
Overdose — what happens if you take too much
Due to the characteristics of this preparation, no toxic effects are to be expected with an otic overdose of this product.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Ciprofloxacin and Dexamethasone stay in your body?
The elimination half-life of ciprofloxacin and dexamethasone is about 4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the serum elimination half-life in adults with normal kidney function; it is slightly longer when kidney function is reduced and about 20% longer in older adults, and no metabolite has a materially longer half-life.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: CIPROFLOXACIN HYDROCHLORIDE tablet - DailyMed (FDA label).
Dosage forms
Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- How is Ciprodex rated?
- pharmaranks gives Ciprodex a composite score of 3.2 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Ciprodex cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $3.71 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Ciprodex?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ciprodex. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ciprodex?
- Ciprodex is marketed by Sandoz. You can see Sandoz's full profile, rating, and other products on pharmaranks.
- Is Ciprodex a brand-name or generic drug?
- Ciprodex is a brand-name product with the active ingredient Ciprofloxacin and Dexamethasone. Lower-cost generic equivalents containing Ciprofloxacin and Dexamethasone are available — ask your pharmacist.
- Is Ciprodex available over the counter?
- No. Ciprodex is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ciprodex come in?
- Ciprodex is currently marketed as drops, per the FDA's National Drug Code Directory.
- Is Ciprodex FDA-registered?
- Ciprodex is on record with the U.S. FDA under application number NDA021537. You can verify this on its official FDA label.
- Has Ciprodex been recalled by the FDA?
- Yes. Ciprodex has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Ciprodex safe?
- There's no single safe-or-not verdict. pharmaranks gives Ciprodex a recall-safety score of 64/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Ciprodex?
- Ciprodex's side effects are taken directly from its FDA label. From the label: 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%),… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about CIPROFLOXACIN AND DEXAMETHASONE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 74 reports naming CIPROFLOXACIN AND DEXAMETHASONE — the active ingredient in Ciprodex, and the FDA flagged 42% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue7 reports
- dizziness5 reports
- dyspnoea5 reports
- headache5 reports
- inappropriate schedule of product administration4 reports
- nausea4 reports
- neck pain4 reports
- paraesthesia4 reports
Read these as a signal, not a rate. A report does not mean CIPROFLOXACIN AND DEXAMETHASONE caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
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ciprodex
64/100