Ciprofloxacin Tablets side effects: what 71,199 FDA adverse event reports show
Drug class
Fluoroquinolone antibacterial
Who reports
71,199 reports · 88% serious · 7,869 with death outcome · 55% female
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.
What it is
Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)- 3-quinolinecarboxylic acid.
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.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
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). 1,194 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 96 | 135.0 106.0–171.9ROR 135.2 · calibrated p 2e-8 ✓ | 90.8 EB05 76.5 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=96 · ♀ 100% (drug 55%) | not reported in cached trials |
| Tendon discomfort | 225 | 125.3 107.2–146.5ROR 125.7 · calibrated p 2e-8 ✓ | 87.1 EB05 78.0 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=221 | not reported in cached trials |
| Geotrichum infection | 56 | 105.3 77.6–143.0ROR 105.4 · calibrated p 1e-7 ✓ | 75.6 EB05 60.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=56 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Tendon pain | 1,642 | 81.5 77.2–86.1ROR 83.4 · calibrated p 4e-7 ✓ | 63.8 EB05 61.2 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious n=1,543 · 71% consumer | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 163 | 52.5 44.5–62.0ROR 52.6 · calibrated p 1e-5 ✓ | 44.4 EB05 39.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=163 | not reported in cached trials |
| Dysbiosis | 113 | 48.3 39.6–58.9ROR 48.3 · calibrated p 2e-5 ✓ | 41.3 EB05 35.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=113 | not reported in cached trials |
| Nephrogenic anaemia | 648 | 47.3 43.6–51.4ROR 47.7 · calibrated p 2e-5 ✓ | 40.8 EB05 38.2 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=648 | not reported in cached trials |
| Hyperparathyroidism secondary | 350 | 47.2 42.1–52.8ROR 47.4 · calibrated p 2e-5 ✓ | 40.6 EB05 37.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=350 | not reported in cached trials |
| Tendon disorder | 830 | 42.8 39.8–46.0ROR 43.3 · calibrated p 3e-5 ✓ | 37.4 EB05 35.3 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=769 | not reported in cached trials |
| Rebound acid hypersecretion | 384 | 42.1 37.8–46.8ROR 42.3 · calibrated p 4e-5 ✓ | 36.8 EB05 33.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=384 · 100% consumer | not reported in cached trials |
| Crystal nephropathy | 69 | 39.2 30.5–50.4ROR 39.2 · calibrated p 8e-5 ✓ | 34.3 EB05 28.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=69 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Tendonitis | 1,752 | 37.3 35.5–39.2ROR 38.2 · calibrated p 7e-5 ✓ | 33.2 EB05 31.9 · IC025 +5.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 25.5 | not reported in cached trials |
| Nasal oedema | 197 | 36.3 31.3–42.1ROR 36.4 · calibrated p 1e-4 ✓ | 32.3 EB05 28.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=197 · ♀ 100% (drug 55%) · 92% clinician | not reported in cached trials |
| Small fibre neuropathy | 78 | 35.1 27.8–44.4ROR 35.2 · calibrated p 1e-4 ✓ | 31.2 EB05 25.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=78 · ♀ 0% (drug 55%) · 100% consumer | not reported in cached trials |
| Joint noise | 169 | 28.1 24.0–32.8ROR 28.1 · calibrated p 4e-4 ✓ | 25.6 EB05 22.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=160 · 78% consumer | not reported in cached trials |
| Female genital tract fistula | 137 | 25.4 21.3–30.2ROR 25.5 · calibrated p 7e-4 ✓ | 23.4 EB05 20.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=137 · ♀ 100% (drug 55%) | not reported in cached trials |
| Joint crepitation | 155 | 24.5 20.8–28.9ROR 24.6 · calibrated p 8e-4 ✓ | 22.6 EB05 19.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=148 | not reported in cached trials |
| Chronic fatigue syndrome | 104 | 23.8 19.5–29.0ROR 23.8 · calibrated p 1e-3 ✓ | 22.0 EB05 18.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=103 · 100% consumer | not reported in cached trials |
| Tendon rupture (torn tendon) | 894 | 22.9 21.4–24.5ROR 23.1 · calibrated p 1e-3 ✓ | 21.3 EB05 20.1 · IC025 +4.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 14.6 | not reported in cached trials |
| Connective tissue disorder | 100 | 22.2 18.1–27.2ROR 22.2 · calibrated p 0.001 ✓ | 20.6 EB05 17.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=98 | not reported in cached trials |
| Tendon injury | 257 | 21.7 19.1–24.6ROR 21.8 · calibrated p 0.001 ✓ | 20.2 EB05 18.2 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=246 | not reported in cached trials |
| Pouchitis | 59 | 21.6 16.6–28.1ROR 21.6 · calibrated p 0.002 ✓ | 20.0 EB05 16.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=58 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| End stage renal disease | 1,243 | 21.3 20.1–22.5ROR 21.6 · calibrated p 0.001 ✓ | 19.9 EB05 19.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 | not reported in cached trials |
| Epicondylitis | 94 | 19.5 15.9–24.1ROR 19.6 · calibrated p 0.002 ✓ | 18.3 EB05 15.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=94 · 100% consumer | not reported in cached trials |
| Pseudomembranous colitis | 132 | 18.4 15.4–21.9ROR 18.4 · calibrated p 0.003 ✓ | 17.3 EB05 14.9 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=132 · 100% clinician | not reported in cached trials |
| Vanishing bile duct syndrome | 61 | 17.1 13.2–22.1ROR 17.1 · calibrated p 0.005 ✓ | 16.1 EB05 12.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Radiculopathy | 137 | 16.1 13.5–19.1ROR 16.1 · calibrated p 0.005 ✓ | 15.3 EB05 13.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=137 · ♀ 100% (drug 55%) | not reported in cached trials |
| Acinetobacter infection | 56 | 16.0 12.2–21.0ROR 16.0 · calibrated p 0.006 ✓ | 15.1 EB05 12.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=56 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Chronic kidney disease | 3,958 | 16.0 15.5–16.5ROR 16.9 · calibrated p 0.004 ✓ | 15.2 EB05 14.8 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 12.9 · serious PRR 10.1 | not reported in cached trials |
| Muscle rupture | 198 | 15.8 13.7–18.2ROR 15.8 · calibrated p 0.006 ✓ | 15.0 EB05 13.3 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=195 | not reported in cached trials |
| Clostridium test positive | 108 | 15.3 12.6–18.6ROR 15.3 · calibrated p 0.007 ✓ | 14.5 EB05 12.3 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=108 · 100% clinician | not reported in cached trials |
| Tubulointerstitial nephritis | 894 | 14.7 13.8–15.7ROR 14.9 · calibrated p 0.007 ✓ | 14.0 EB05 13.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | age-adj. PRR 11.5 · serious PRR 9.2 | not reported in cached trials |
| Pathogen resistance | 430 | 14.6 13.2–16.0ROR 14.6 · calibrated p 0.008 ✓ | 13.9 EB05 12.8 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 · 96% clinician | not reported in cached trials |
| Proctitis | 131 | 14.4 12.1–17.1ROR 14.4 · calibrated p 0.009 ✓ | 13.7 EB05 11.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=131 · ♀ 100% (drug 55%) | not reported in cached trials |
| Fistula discharge | 59 | 14.3 11.0–18.6ROR 14.3 · calibrated p 0.010 ✓ | 13.5 EB05 10.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=59 · 100% clinician | not reported in cached trials |
| Plantar fasciitis | 153 | 14.0 11.9–16.4ROR 14.0 · calibrated p 0.010 ✓ | 13.3 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=149 · 70% consumer | not reported in cached trials |
| Weight bearing difficulty | 122 | 13.9 11.6–16.6ROR 13.9 · calibrated p 0.010 ✓ | 13.2 EB05 11.3 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=119 | not reported in cached trials |
| Clostridium difficile colitis | 478 | 13.8 12.6–15.2ROR 13.9 · calibrated p 0.010 ✓ | 13.2 EB05 12.3 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 12.1 · serious PRR 8.8 · 92% clinician | not reported in cached trials |
| Depersonalisation/derealisation disorder | 72 | 13.7 10.9–17.4ROR 13.8 · calibrated p 0.011 ✓ | 13.0 EB05 10.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=72 · 100% consumer | not reported in cached trials |
| Linear iga disease | 73 | 13.5 10.7–17.0ROR 13.5 · calibrated p 0.012 ✓ | 12.8 EB05 10.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=73 · ♀ 0% (drug 55%) · 100% clinician | not 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.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Tendon disorder | 4,347 | 37.836.7–39.0 | signal |
| Severe cutaneous reaction | 1,878 | 7.67.3–8.0 | signal |
| Kidney injury | 7,379 | 4.84.7–4.9 | signal |
| Neutropenia / agranulocytosis | 2,654 | 3.23.1–3.3 | signal |
| Rhabdomyolysis / myopathy | 801 | 2.92.7–3.1 | signal |
| Hyponatraemia | 727 | 2.72.5–2.9 | signal |
| Arrhythmia / qt | 1,713 | 2.62.5–2.7 | signal |
| Serious infection | 6,755 | 2.62.5–2.6 | signal |
| Depression | 2,293 | 2.42.3–2.5 | signal |
| Liver injury | 2,417 | 2.42.3–2.5 | signal |
| Thrombocytopenia | 1,693 | 2.32.2–2.4 | signal |
| Anaemia | 2,291 | 2.32.2–2.4 | signal |
| Anaphylaxis / angioedema | 840 | 2.01.9–2.1 | raised |
| Opportunistic infection | 821 | 1.81.7–1.9 | raised |
| Interstitial lung disease | 562 | 1.71.6–1.9 | raised |
| Gi bleeding | 1,029 | 1.71.6–1.8 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ciprofloxacin Tablets 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).
- NCT03354598 — Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult W (N=1671, PHASE3; 12 AE terms posted; arms: Sulopenem-etzadroxil/Probenecid; Ciprofloxacin)
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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 4,323 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.759 | 1.6 EB05 1.6 · IC025 +0.7 | Labeled — boxed warning synonym match | age-adj. PRR 1.5 · serious PRR 1.8 | not reported in cached trials |
| Pain | 4,210 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.990 | 2.0 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | age-adj. PRR 2.1 · serious PRR 2.0 | NCT03354598: 1/833 (0.1%) on Ciprofloxacin Tablets (serious AE) |
| Acute kidney injury (sudden kidney damage) | 4,192 | 8.3 8.1–8.6ROR 8.8 · calibrated p 0.050 ✓ | 8.1 EB05 7.9 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 5.1 · serious PRR 5.3 | not reported in cached trials |
| Nausea | 4,130 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.692 | 1.5 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.7 | not reported in cached trials |
| Diarrhoea (diarrhea) | 4,130 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.918 | 1.9 EB05 1.8 · IC025 +0.9 | Likely indication confounding term in indications; also in warnings | age-adj. PRR 1.7 · serious PRR 2.0 | NCT03354598: 1/827 (0.1%) on Ciprofloxacin Tablets (serious AE) |
| Arthralgia (joint pain) | 4,045 | 2.9 2.8–3.0ROR 3.0 · calibrated p 0.624 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.8 · serious PRR 3.2 | not reported in cached trials |
| Chronic kidney disease | 3,958 | 16.0 15.5–16.5ROR 16.9 · calibrated p 0.004 ✓ | 15.2 EB05 14.8 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 12.9 · serious PRR 10.1 | not reported in cached trials |
| Drug ineffective (drug did not work) | 3,954 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.229 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 1.1 · serious PRR 1.5 | not reported in cached trials |
| Drug hypersensitivity | 3,472 | 5.3 5.2–5.5ROR 5.6 · calibrated p 0.181 | 5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 4.7 · serious PRR 4.6 · ♀ 81% (drug 55%) | not reported in cached trials |
| Off label use (used outside approved label) | 3,433 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.422 | 1.2 EB05 1.1 · IC025 +0.2 | Reporting / coding artifact | age-adj. PRR 1.1 · serious PRR 1.3 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 3,330 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.815 | 1.7 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.5 | not reported in cached trials |
| Pyrexia (fever) | 3,209 | 2.7 2.7–2.8ROR 2.8 · calibrated p 0.685 | 2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 2.4 · serious PRR 2.2 | not reported in cached trials |
| Vomiting | 3,119 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.950 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 1.8 | not reported in cached trials |
| Anxiety | 3,005 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.559 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.3 · serious PRR 2.8 | not reported in cached trials |
| Headache | 2,850 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.546 | 1.3 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.6 | not 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.
- Vaginal flatulence — n=96, PRR 135.0
- Geotrichum infection — n=56, PRR 105.3
- Chronic kidney disease-mineral and bone disorder — n=163, PRR 52.5
- Dysbiosis — n=113, PRR 48.3
- Nephrogenic anaemia — n=648, PRR 47.3
- Hyperparathyroidism secondary — n=350, PRR 47.2
- Rebound acid hypersecretion — n=384, PRR 42.1
- Crystal nephropathy — n=69, PRR 39.2
- Nasal oedema — n=197, PRR 36.3
- Small fibre neuropathy — n=78, PRR 35.1
✓ 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 Tablets?
In FDA FAERS, the most frequently co-reported reaction terms for Ciprofloxacin Tablets are fatigue, pain, acute kidney injury, 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 Tablets 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 Tablets 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
- FDA label via openFDA (set ID 18414c5a-8153-44f7-b27a-90c290af0a23, effective 20260327; matched on
openfda.generic_name.exact:"CIPROFLOXACIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,234 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
CIPROFLOXACIN, results-bearing studies sorted by enrollment)
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.