Cipro: adverse event reports filed with FDA

9,791

reports as suspect product

0.1% of all reports · about 435 a year

108

reports, 12 months to June 2026

123 in the 12 months before

57.3%

marked serious by the reporter

77.7% across the class

2.2%

record death among outcomes, as reported

213 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Cipro reports recording the termmedian drug in corticosteroid

1. Drug hypersensitivityan allergic-type reaction to a medicine23.4%2,290
2. Neuropathy peripheralnerve damage in hands or feet13.4%1,315
3. Painpain, site not specified8.6%846
4. Arthralgiajoint pain8.5%829
5. Pain in extremitypain in an arm or leg6.5%638
6. Nauseafeeling sick5.2%511
7. Diarrhoealoose or frequent stools5.2%506
8. Anxietyanxiety4.9%477
9. Fatiguetiredness4.4%433
10. Rashskin rash4.4%426
11. Tendonitisinflammation of a tendon4.3%420
12. Hypoaesthesianumbness4.2%416
13. Dizzinesslight-headedness or unsteadiness4.2%415
14. Paraesthesiatingling or pins and needles4.1%403
15. Astheniaweakness or lack of energy4.1%399
16. Headachehead pain4%395
17. Tendon rupturea torn tendon3.7%366
18. Gait disturbancedifficulty walking3.6%353
19. Drug ineffectivethe medicine did not work as expected3.5%344
20. Insomniadifficulty sleeping3.5%341
21. Myalgiamuscle pain3.2%314
22. Depressionlow mood3.2%310
23. Dyspnoeashortness of breath3.2%310
24. Tendon pain3.1%308
25. Vomitingbeing sick2.9%287
26. Urinary tract infectionbladder or urinary infection2.9%282
27. Feeling abnormalfeeling odd or not right2.8%272
28. Tendon disorder2.7%268
29. Malaisegeneral feeling of being unwell2.7%267
30. Pruritusitching2.7%266

Top 30 of 1,178 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 74 drugs in the corticosteroid class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 808,789 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 87.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 9,791 reports.

Drugs most often listed in the same reports

Other products listed in reports where Cipro is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the corticosteroid class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Cipro as a suspect or interacting product; reports listing it only as a concomitant medication (11,362) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.