Ciprofolxacin side effects: what 71,186 FDA adverse event reports show

Ciprofolxacin · Ciprofloxacin · 1,234 reaction terms · 328,489 drug–reaction co-reports · data 2026-09-14

Drug class

Fluoroquinolone antibacterial

FDA label, Indications wording

Brand names

Ciprofloxacin

openFDA label

Who reports

71,186 reports · 88% serious · 7,867 with death outcome · 55% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Click here to enter Indications 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. ) • Bone and Joint Infections ( Error! Hyperlink reference not valid.

FDA label, Indications and Usage

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.

FDA label, Description section

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) 6Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 27

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.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Vaginal flatulence	96	135.0 106.0–172.0ROR 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%)	no trial arm names this drug
Tendon discomfort	225	125.3 107.2–146.5ROR 125.7 · calibrated p 2e-8 ✓	87.2 EB05 78.0 · IC025 +6.0 3/3 methods agree	Labeled (related wording) related wording	serious n=221	no trial arm names this drug
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	no trial arm names this drug
Tendon pain	1,641	81.5 77.2–86.0ROR 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	no trial arm names this drug
Chronic kidney disease-mineral and bone disorder	163	52.5 44.5–62.1ROR 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	no trial arm names this drug
Dysbiosis	113	48.3 39.6–58.9ROR 48.4 · calibrated p 2e-5 ✓	41.3 EB05 35.3 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=113	no trial arm names this drug
Nephrogenic anaemia	648	47.3 43.6–51.4ROR 47.8 · calibrated p 2e-5 ✓	40.8 EB05 38.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=648	no trial arm names this drug
Hyperparathyroidism secondary	350	47.2 42.2–52.8ROR 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	no trial arm names this drug
Tendon disorder	829	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=768	no trial arm names this drug
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	no trial arm names this drug
Crystal nephropathy	69	39.2 30.5–50.4ROR 39.2 · calibrated p 7e-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	no trial arm names this drug
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	no trial arm names this drug
Nasal oedema	197	36.3 31.3–42.1ROR 36.4 · calibrated p 1e-4 ✓	32.3 EB05 28.7 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=197 · ♀ 100% (drug 55%) · 92% clinician	no trial arm names this drug
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	no trial arm names this drug
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	no trial arm names this drug
Female genital tract fistula	137	25.4 21.3–30.3ROR 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%)	no trial arm names this drug
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	no trial arm names this drug
Chronic fatigue syndrome	104	23.8 19.5–29.0ROR 23.8 · calibrated p 1e-3 ✓	22.0 EB05 18.7 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=103 · 100% consumer	no trial arm names this drug
Tendon rupture (torn tendon)	893	22.8 21.4–24.4ROR 23.1 · calibrated p 1e-3 ✓	21.2 EB05 20.1 · IC025 +4.3 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 14.5	no trial arm names this drug
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	no trial arm names this drug
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	no trial arm names this drug
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	no trial arm names this drug
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	no trial arm names this drug
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	no trial arm names this drug
Pseudomembranous colitis	131	18.2 15.3–21.7ROR 18.2 · calibrated p 0.003 ✓	17.1 EB05 14.8 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious n=131 · 100% clinician	no trial arm names this drug
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	no trial arm names this drug
Radiculopathy	137	16.1 13.6–19.1ROR 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%)	no trial arm names this drug
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	no trial arm names this drug
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	no trial arm names this drug
Muscle rupture	198	15.8 13.7–18.2ROR 15.9 · calibrated p 0.006 ✓	15.0 EB05 13.3 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious n=195	no trial arm names this drug
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	no trial arm names this drug
Tubulointerstitial nephritis	894	14.7 13.8–15.7ROR 14.9 · calibrated p 0.007 ✓	14.1 EB05 13.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	age-adj. PRR 11.5 · serious PRR 9.2	no trial arm names this drug
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	no trial arm names this drug
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%)	no trial arm names this drug
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	no trial arm names this drug
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	no trial arm names this drug
Weight bearing difficulty	122	13.9 11.6–16.7ROR 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	no trial arm names this drug
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	no trial arm names this drug
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	no trial arm names this drug
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	no trial arm names this drug

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	4,344	37.836.7–39.0	signal
Severe cutaneous reaction	1,877	7.67.3–7.9	signal
Kidney injury	7,378	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	1,712	2.62.5–2.7	signal
Serious infection	6,755	2.62.5–2.7	signal
Depression	2,292	2.42.3–2.5	signal
Liver injury	2,416	2.42.3–2.5	signal
Thrombocytopenia	1,693	2.32.2–2.4	signal
Anaemia	2,290	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)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Ciprofolxacin (searched CIPROFOLXACIN).

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)	4,321	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	no trial arm names this drug
Pain	4,209	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	no trial arm names this drug
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	no trial arm names this drug
Nausea	4,129	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	no trial arm names this drug
Diarrhoea (diarrhea)	4,129	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	no trial arm names this drug
Arthralgia (joint pain)	4,045	2.9 2.8–3.0ROR 3.0 · calibrated p 0.623	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	no trial arm names this drug
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	no trial arm names this drug
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	no trial arm names this drug
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%)	no trial arm names this drug
Off label use (used outside approved label)	3,433	1.2 1.1–1.2ROR 1.2 · calibrated p 0.423	1.2 EB05 1.1 · IC025 +0.2	Reporting / coding artifact	age-adj. PRR 1.1 · serious PRR 1.3	no trial arm names this drug
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	no trial arm names this drug
Pyrexia (fever)	3,208	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	no trial arm names this drug
Vomiting	3,118	2.0 1.9–2.0ROR 2.0 · calibrated p 0.949	2.0 EB05 1.9 · IC025 +0.9	Labeled adverse reaction exact term	age-adj. PRR 1.8 · serious PRR 1.8	no trial arm names this drug
Anxiety	3,004	3.1 3.0–3.2ROR 3.2 · calibrated p 0.560	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	no trial arm names this drug
Headache	2,847	1.3 1.3–1.4ROR 1.4 · calibrated p 0.545	1.3 EB05 1.3 · IC025 +0.4	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.6	no trial arm names this drug

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

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 Ciprofolxacin?

In FDA FAERS, the most frequently co-reported reaction terms for Ciprofolxacin 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 Ciprofolxacin 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 Ciprofolxacin 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 0ce2221d-940f-4c07-ba2e-fccb491f6b9b, effective 20250401; matched on openfda.generic_name.exact:"CIPROFOLXACIN")
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, field patient.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 CIPROFOLXACIN, 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.