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Ciprofloxacin Hydrochloride side effects: what 96,695 FDA adverse event reports show

Ciprofloxacin Hydrochloride · 1,213 reaction terms · 452,652 drug–reaction co-reports · data 2026-09-14
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Drug class

Fluoroquinolone antibacterial

FDA label, Indications wording

Who reports

96,695 reports · 83% serious · 9,728 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: • Skin and Skin Structure Infections ( Error! Hyperlink reference not valid.

FDA label, Indications and Usage

What it is

Ciprofloxacin is a quinolone that is quinolin-4(1H)-one bearing cyclopropyl, carboxylic acid, fluoro and piperazin-1-yl substituents at positions 1, 3, 6 and 7, respectively.

PubChem CID 2764 (ChEBI)

Boxed warning

SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including ciprofloxacin, have been assoc.

FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 2Labeled adverse reaction 2Labeled (related wording) 8Likely indication confounding 2Lab value / disease marker 1Not in label — unassessed 25
What the badges mean

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,173 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Vaginal flatulence177301.6
239.9–379.2ROR 302.1 · calibrated p 2e-11 ✓
123.8 EB05 109.2 · IC025 +6.3
3/3 methods agree
Not in label — unassessedserious n=177 · ♀ 100% (drug 58%)not reported in cached trials
Total lung capacity increased158300.5
235.9–382.7ROR 301.0 · calibrated p 2e-11 ✓
123.4 EB05 108.1 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious n=158 · ♀ 100% (drug 58%) · 100% cliniciannot reported in cached trials
Chronic kidney disease-mineral and bone disorder19247.0
40.2–54.9ROR 47.1 · calibrated p 2e-5 ✓
38.6 EB05 34.2 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious n=192not reported in cached trials
Tendon disorder1,13545.5
42.7–48.5ROR 46.1 · calibrated p 2e-5 ✓
37.7 EB05 35.9 · IC025 +5.1
3/3 methods agree
Labeled adverse reaction
exact term
serious n=1,016not reported in cached trials
Hyperparathyroidism secondary41542.4
38.2–47.1ROR 42.6 · calibrated p 4e-5 ✓
35.5 EB05 32.7 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious n=415not reported in cached trials
Nephrogenic anaemia75541.7
38.6–45.0ROR 42.0 · calibrated p 4e-5 ✓
35.0 EB05 32.9 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=755not reported in cached trials
Dysbiosis11937.7
31.0–45.8ROR 37.8 · calibrated p 8e-5 ✓
32.0 EB05 27.5 · IC025 +4.5
3/3 methods agree
Not in label — unassessedserious n=119not reported in cached trials
Tendonitis2,26836.9
35.3–38.6ROR 37.8 · calibrated p 7e-5 ✓
31.6 EB05 30.5 · IC025 +4.9
3/3 methods agree
Labeled — boxed warning
synonym match
serious PRR 24.8not reported in cached trials
Female genital tract fistula24636.1
31.5–41.3ROR 36.1 · calibrated p 1e-4 ✓
30.9 EB05 27.8 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious n=246 · ♀ 100% (drug 58%)not reported in cached trials
Rebound acid hypersecretion43735.9
32.5–39.8ROR 36.1 · calibrated p 1e-4 ✓
30.9 EB05 28.5 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious n=437 · 100% consumernot reported in cached trials
Nasal oedema24934.9
30.5–39.9ROR 35.0 · calibrated p 1e-4 ✓
30.0 EB05 27.0 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious n=249 · ♀ 100% (drug 58%) · 100% cliniciannot reported in cached trials
Small fibre neuropathy9331.5
25.4–39.2ROR 31.6 · calibrated p 2e-4 ✓
27.5 EB05 23.1 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious n=92 · ♀ 0% (drug 58%) · 100% consumernot reported in cached trials
Joint noise20826.0
22.5–30.0ROR 26.0 · calibrated p 6e-4 ✓
23.2 EB05 20.7 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=196 · 79% consumernot reported in cached trials
Pouchitis9125.5
20.5–31.7ROR 25.5 · calibrated p 7e-4 ✓
22.8 EB05 19.1 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious n=87 · ♀ 0% (drug 58%)not reported in cached trials
Tendon rupture (torn tendon)1,30325.4
24.0–26.9ROR 25.8 · calibrated p 6e-4 ✓
22.8 EB05 21.8 · IC025 +4.4
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 16.3not reported in cached trials
Joint crepitation19823.6
20.4–27.3ROR 23.6 · calibrated p 9e-4 ✓
21.3 EB05 18.9 · IC025 +4.1
3/3 methods agree
Not in label — unassessedserious n=180not reported in cached trials
Chronic fatigue syndrome12421.2
17.6–25.5ROR 21.2 · calibrated p 0.002 ✓
19.3 EB05 16.6 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=122 · 100% consumernot reported in cached trials
Radiculopathy23020.6
18.0–23.6ROR 20.7 · calibrated p 0.002 ✓
18.9 EB05 16.9 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious n=228 · ♀ 100% (drug 58%)not reported in cached trials
Connective tissue disorder12420.6
17.1–24.8ROR 20.6 · calibrated p 0.002 ✓
18.8 EB05 16.2 · IC025 +3.8
3/3 methods agree
Not in label — unassessedserious n=120not reported in cached trials
Proctitis23519.8
17.3–22.6ROR 19.8 · calibrated p 0.002 ✓
18.1 EB05 16.3 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=235 · ♀ 85% (drug 58%)not reported in cached trials
Ligament disorder7519.3
15.3–24.5ROR 19.4 · calibrated p 0.003 ✓
17.7 EB05 14.6 · IC025 +3.6
3/3 methods agree
Not in label — unassessed♀ 100% (drug 58%) · 100% consumernot reported in cached trials
End stage renal disease1,42518.1
17.2–19.1ROR 18.4 · calibrated p 0.003 ✓
16.8 EB05 16.1 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious PRR 11.6not reported in cached trials
Epicondylitis11517.8
14.7–21.6ROR 17.9 · calibrated p 0.004 ✓
16.5 EB05 14.1 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=113 · 100% consumernot reported in cached trials
Oesophageal spasm13917.6
14.8–20.9ROR 17.6 · calibrated p 0.004 ✓
16.3 EB05 14.1 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=138 · ♀ 100% (drug 58%)not reported in cached trials
Fistula discharge9216.9
13.7–20.9ROR 16.9 · calibrated p 0.005 ✓
15.6 EB05 13.1 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=88 · ♀ 100% (drug 58%)not reported in cached trials
Pseudomembranous colitis14514.9
12.6–17.7ROR 14.9 · calibrated p 0.007 ✓
14.0 EB05 12.1 · IC025 +3.5
3/3 methods agree
Labeled adverse reaction
exact term
serious n=145 · 100% cliniciannot reported in cached trials
Rectal abscess10414.2
11.7–17.3ROR 14.2 · calibrated p 0.009 ✓
13.3 EB05 11.3 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=104 · ♀ 0% (drug 58%)not reported in cached trials
Clostridium test positive13314.0
11.8–16.7ROR 14.0 · calibrated p 0.010 ✓
13.2 EB05 11.4 · IC025 +3.4
3/3 methods agree
Lab value / disease markerserious n=133 · 100% cliniciannot reported in cached trials
Chronic sinusitis22613.9
12.1–15.9ROR 13.9 · calibrated p 0.010 ✓
13.0 EB05 11.7 · IC025 +3.5
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=224 · ♀ 100% (drug 58%)not reported in cached trials
Weight bearing difficulty15413.1
11.1–15.4ROR 13.1 · calibrated p 0.013 ✓
12.3 EB05 10.7 · IC025 +3.3
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=147not reported in cached trials
Plantar fasciitis19012.9
11.2–15.0ROR 12.9 · calibrated p 0.013 ✓
12.2 EB05 10.8 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=182 · 72% consumernot reported in cached trials
Tubulointerstitial nephritis99612.1
11.4–12.9ROR 12.2 · calibrated p 0.016 ✓
11.5 EB05 10.9 · IC025 +3.4
3/3 methods agree
Not in label — unassessedage-adj. PRR 9.8 · serious PRR 8.0not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

ConceptReportsPRR 95% CIReading
Tendon disorder5,74138.437.3–39.4signal
Severe cutaneous reaction2,1496.46.2–6.7signal
Kidney injury8,8164.24.2–4.3signal
Neutropenia / agranulocytosis3,1722.82.7–2.9signal
Serious infection9,6942.72.7–2.8signal
Rhabdomyolysis / myopathy9172.52.3–2.6signal
Depression3,1422.42.4–2.5signal
Hyponatraemia8992.42.3–2.6signal
Arrhythmia / qt2,0922.42.3–2.5signal
Anaemia3,0992.32.2–2.3signal
Thrombocytopenia2,1412.12.0–2.2signal
Liver injury2,9112.12.0–2.2signal
Anaphylaxis / angioedema1,1191.91.8–2.1raised
Opportunistic infection1,0991.81.7–1.9raised
Gi bleeding1,4541.71.6–1.8raised
Venous thromboembolism1,5661.61.5–1.7raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Ciprofloxacin as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Pain6,1392.2
2.1–2.2ROR 2.3 · calibrated p 0.924
2.2 EB05 2.1 · IC025 +1.1
3/3 methods agree
Labeled adverse reaction
exact term
age-adj. PRR 2.3 · serious PRR 2.2NCT03354598: 1/833 (0.1%) on Ciprofloxacin (serious AE)
Fatigue (tiredness)6,0801.7
1.7–1.7ROR 1.7 · calibrated p 0.800
1.7 EB05 1.7 · IC025 +0.7Labeled — boxed warning
synonym match
age-adj. PRR 1.6 · serious PRR 1.9not reported in cached trials
Nausea5,8961.6
1.6–1.7ROR 1.7 · calibrated p 0.748
1.6 EB05 1.6 · IC025 +0.7Labeled adverse reaction
exact term
age-adj. PRR 1.5 · serious PRR 1.8not reported in cached trials
Diarrhoea (diarrhea)5,8742.0
1.9–2.0ROR 2.1 · calibrated p 0.973
2.0 EB05 1.9 · IC025 +0.9Likely indication confounding
term in indications; also in warnings
age-adj. PRR 1.8 · serious PRR 2.1NCT03354598: 1/827 (0.1%) on Ciprofloxacin (serious AE)
Arthralgia (joint pain)5,5873.0
2.9–3.0ROR 3.1 · calibrated p 0.604
2.9 EB05 2.9 · IC025 +1.5
3/3 methods agree
Labeled adverse reaction
exact term
age-adj. PRR 2.9 · serious PRR 3.3not reported in cached trials
Drug ineffective (drug did not work)5,1450.8
0.8–0.9ROR 0.8 · calibrated p 0.206
0.8 EB05 0.8 · IC025 -0.3
PRR-only: not supported by EBGM or IC
Reporting / coding artifactage-adj. PRR 1.1 · serious PRR 1.4not reported in cached trials
Dyspnoea (shortness of breath)4,7341.8
1.8–1.9ROR 1.9 · calibrated p 0.868
1.8 EB05 1.8 · IC025 +0.8Labeled adverse reaction
exact term
age-adj. PRR 1.7 · serious PRR 1.6not reported in cached trials
Off label use (used outside approved label)4,6461.2
1.1–1.2ROR 1.2 · calibrated p 0.420
1.2 EB05 1.1 · IC025 +0.2Reporting / coding artifactage-adj. PRR 1.1 · serious PRR 1.3not reported in cached trials
Vomiting4,4302.1
2.0–2.1ROR 2.1 · calibrated p 0.997
2.0 EB05 2.0 · IC025 +1.0Labeled adverse reaction
exact term
age-adj. PRR 1.9 · serious PRR 1.9not reported in cached trials
Anxiety4,1813.2
3.1–3.3ROR 3.3 · calibrated p 0.534
3.2 EB05 3.1 · IC025 +1.6
3/3 methods agree
Labeled adverse reaction
exact term
age-adj. PRR 3.5 · serious PRR 3.0not reported in cached trials
Headache4,0911.4
1.4–1.5ROR 1.4 · calibrated p 0.601
1.4 EB05 1.4 · IC025 +0.5Labeled adverse reaction
exact term
age-adj. PRR 1.4 · serious PRR 1.8not reported in cached trials

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Ciprofloxacin (fluoroquinolones) ↔ Tendon rupture / tendinitis.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Ciprofloxacin?

In FDA FAERS, the most frequently co-reported reaction terms for Ciprofloxacin are drug hypersensitivity, pain, fatigue, nausea, diarrhoea, arthralgia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Ciprofloxacin have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including ciprofloxacin, have been assoc.

Do FAERS signals prove that Ciprofloxacin causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.