Fluoroquinolone Antibacterial · Brand: Ciloxan, Ciprofloxacin In Dextrose + 2 more

Ciprofloxacin Side Effects: Common, Serious & FDA Warnings

Creator: MedivaScan
Published: 2026-05-28T04:28:23.034875+00:00

Verified from FDA on May 28, 2026Refreshes every 6 hoursFDA-Sourced

FDA-Approved For

Infections

Quick answer

Based on 95,000+ FDA adverse event reports, the most-reported ciprofloxacin reactions include drug hypersensitivity, pain, and fatigue. FDA reports 3 active Class II recalls of ciprofloxacin, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

Common Side Effects of Ciprofloxacin

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for ciprofloxacin. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

Reaction	Reports	% of total
Drug Hypersensitivity	6,156	6.4%
Pain	6,095	6.4%
Fatigue	6,029	6.3%
Diarrhoea	5,838	6.1%
Nausea	5,837	6.1%
Arthralgia	5,544	5.8%
Acute Kidney Injury	4,721	4.9%
Dyspnoea	4,648	4.9%
Chronic Kidney Disease	4,553	4.8%
Vomiting	4,353	4.5%

Source: FDA FAERS·Updated May 28, 2026·n=95,824+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flag	Reports	% of total
Serious reports (any flag)	—	—
Hospitalization	—	—

Ciprofloxacin Recalls

FDA enforcement actions matched to ciprofloxacin via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

Date	Reason	Class	Quantity	Status
2025-03-26	Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle FDC Limited	Class II	90960 bottles	Ongoing
2025-01-15	Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle FDC Limited	Class II	136,181 bottles	Ongoing
2024-08-07	Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. FDC Limited	Class II	66,528 bottles	Ongoing

Source: FDA Drug Enforcement Reports·Updated May 28, 2026·Refreshes every 6 hours·verify on FDA →

Show 6 closed recalls (2012 to 2022)

Includes resolved and terminated recalls matched to ciprofloxacin. Most recent first.

Date	Reason	Class	Quantity	Status
2022-06-15	cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office	Class II	7 bottles	Terminated
2019-11-27	Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc.	Class II	3060 units	Resolved
2019-11-27	Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc.	Class II	6024 units	Resolved
2019-11-27	Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc.	Class II	636 units	Resolved
2013-04-03	Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet. West-ward Pharmaceutical Corp.	Class II	7,136 units	Terminated
2012-07-25	Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels. Pack Pharmaceuticals	Class III	4,848 bottles	Terminated

Ciprofloxacin Shortages

FDA-listed shortages of ciprofloxacin products. Strength and dosage-form level detail.

No active or recent shortages of ciprofloxacin are listed. We refresh this view daily.

Source: FDA Drug Shortages·Updated May 28, 2026

Is Ciprofloxacin Safe?

Ciprofloxacin is FDA-approved and the label does not carry a boxed warning.

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (ciprofloxacin label)·Updated May 28, 2026

FDA-Approved Indications

Ciprofloxacin is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

Infections

INDICATIONS AND USAGE Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aeruginosa Serratia marcescens * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group) * Conjunctivitis: Haemophilus influenzae Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections.

Source: DailyMed (ciprofloxacin label)·Updated May 28, 2026·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of ciprofloxacin?

Drug hypersensitivity, pain, and fatigue are among the most-reported reactions in FDA FAERS data for ciprofloxacin. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.

Is ciprofloxacin the same as Ciloxan?

Ciprofloxacin is the generic name; Ciloxan is a brand name for the same active ingredient. Other brand names include Ciprofloxacin In Dextrose, Cipro, and Ciprofloxacin Otic. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.

Has ciprofloxacin been recalled?

Yes. Ciprofloxacin has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by CGMP deviations, contamination or foreign material, and mislabeling. See the recalls table on this page for current counts, firm names, dates, and lot quantities.

What are ciprofloxacin's current ongoing recalls about?

Active ciprofloxacin recalls are listed in the recalls table above with their class, reason, firm, and affected lots. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.

What do FDA recall classes mean?

Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

Source	Endpoint	Refresh
FAERS reactions	openFDA `/drug/event.json` count API. Aggregated per drug per reaction term; we do not store individual reports.	Daily
Recalls	openFDA `/drug/enforcement.json`. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.	6 hours
Shortages	FDA Drug Shortages list.	Daily
Boxed warnings & label sections	openFDA `/drug/label.json`. Labels are stable; monthly cadence is sufficient.	Monthly
Condition categories	Synonym-mapped from drug_labels.indications. Methodology at /methodology/.	Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.