Drug · FAERS side-effect profile with label screen
Furosemide side effects: what 398,182 FDA adverse event reports show
Who reports
398,182 reports · 81% serious · 61,850 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Furosemide Injection is a loop diuretic indicated for: • The treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease ( 1.1 ) • Acute pulmonary edema as adjunctive therapy ( 1.2 ) 1.1 Edema Furosemide Injection is ind.
FDA label, Indications and Usage
What it is
Furosemide is a chlorobenzoic acid that is 4-chlorobenzoic acid substituted by a (furan-2-ylmethyl)amino and a sulfamoyl group at position 2 and 5 respectively.
PubChem CID 3440 (ChEBI)
Boxed warning
None in the current 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 adverse reaction 1Labeled (related wording) 2Likely indication confounding 3Reporting / coding artifact 1Lab value / disease marker 6Not in label — unassessed 27
What the badges mean
- 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). 1,163 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nephrogenic anaemia | 1,661 | 28.7 27.0–30.4ROR 28.8 · calibrated p 3e-4 ✓ | 18.7 EB05 18.0 · IC025 +4.1 3/3 methods agree vs other Loop Diuretics: PRR 9.3 (8.3–10.3) | Likely indication confounding shares a disease stem with the indications wording | serious n=1,660 | no trial arm names this drug |
| Hyperparathyroidism secondary | 895 | 28.4 26.2–30.8ROR 28.5 · calibrated p 3e-4 ✓ | 18.6 EB05 17.6 · IC025 +4.1 3/3 methods agree vs other Loop Diuretics: PRR 8.1 (7.1–9.3) | Not in label — unassessed | serious n=893 | no trial arm names this drug |
| Chronic kidney disease-mineral and bone disorder | 367 | 26.9 23.7–30.5ROR 26.9 · calibrated p 5e-4 ✓ | 17.9 EB05 16.4 · IC025 +4.0 3/3 methods agree vs other Loop Diuretics: PRR 10.9 (8.6–13.9) | Not in label — unassessed | serious n=367 | no trial arm names this drug |
| Cardioactive drug level increased | 430 | 24.9 22.2–27.9ROR 24.9 · calibrated p 7e-4 ✓ | 17.0 EB05 15.7 · IC025 +3.9 3/3 methods agree vs other Loop Diuretics: PRR 37.8 (25.7–55.8) | Lab value / disease marker | serious n=426 · 100% clinician | no trial arm names this drug |
| Metabolic alkalosis | 428 | 19.0 17.0–21.3ROR 19.0 · calibrated p 0.003 ✓ | 14.1 EB05 13.0 · IC025 +3.6 3/3 methods agree vs other Loop Diuretics: PRR 33.9 (23.4–49.1) | Labeled (related wording) related wording | serious n=426 · 100% clinician | no trial arm names this drug |
| N-terminal prohormone brain natriuretic peptide increased | 352 | 17.4 15.4–19.6ROR 17.4 · calibrated p 0.004 ✓ | 13.2 EB05 12.1 · IC025 +3.5 3/3 methods agree vs other Loop Diuretics: PRR 11.3 (8.8–14.5) | Lab value / disease marker | serious n=346 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Sedation complication | 599 | 16.3 14.9–17.9ROR 16.4 · calibrated p 0.005 ✓ | 12.6 EB05 11.8 · IC025 +3.5 3/3 methods agree vs other Loop Diuretics: only this drug | Reporting / coding artifact | serious n=597 · ♀ 100% (drug 56%) | no trial arm names this drug |
| Orthopnoea | 751 | 15.9 14.7–17.3ROR 16.0 · calibrated p 0.005 ✓ | 12.4 EB05 11.6 · IC025 +3.5 3/3 methods agree vs other Loop Diuretics: PRR 11.2 (9.5–13.3) | Not in label — unassessed | serious n=726 | no trial arm names this drug |
| Cardiac failure chronic | 996 | 15.8 14.8–17.0ROR 15.9 · calibrated p 0.006 ✓ | 12.3 EB05 11.7 · IC025 +3.5 3/3 methods agree vs other Loop Diuretics: PRR 8.8 (7.7–10.0) | Not in label — unassessed | serious n=994 · ♀ 34% (drug 56%) | no trial arm names this drug |
| Rebound acid hypersecretion | 701 | 15.4 14.1–16.7ROR 15.4 · calibrated p 0.006 ✓ | 12.0 EB05 11.3 · IC025 +3.5 3/3 methods agree vs other Loop Diuretics: PRR 11.8 (9.9–14.1) | Not in label — unassessed | serious n=701 | no trial arm names this drug |
| Creatinine renal clearance decreased | 831 | 13.5 12.5–14.5ROR 13.5 · calibrated p 0.011 ✓ | 10.8 EB05 10.2 · IC025 +3.3 3/3 methods agree vs other Loop Diuretics: only this drug | Lab value / disease marker | serious n=813 · ♀ 84% (drug 56%) | no trial arm names this drug |
| Left atrial dilatation | 264 | 13.4 11.7–15.3ROR 13.4 · calibrated p 0.011 ✓ | 10.8 EB05 9.7 · IC025 +3.2 3/3 methods agree vs other Loop Diuretics: PRR 25.1 (16.7–37.8) | Not in label — unassessed | serious n=264 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Brain natriuretic peptide increased | 590 | 12.3 11.2–13.4ROR 12.3 · calibrated p 0.016 ✓ | 10.0 EB05 9.4 · IC025 +3.2 3/3 methods agree vs other Loop Diuretics: PRR 10.5 (8.7–12.7) | Lab value / disease marker | serious n=565 | no trial arm names this drug |
| Ischaemic cardiomyopathy | 584 | 12.0 11.0–13.2ROR 12.0 · calibrated p 0.017 ✓ | 9.9 EB05 9.2 · IC025 +3.2 3/3 methods agree vs other Loop Diuretics: PRR 14.6 (11.8–18.1) | Not in label — unassessed | serious n=583 · ♀ 28% (drug 56%) | no trial arm names this drug |
| End stage renal disease | 3,380 | 11.6 11.2–12.1ROR 11.7 · calibrated p 0.018 ✓ | 9.7 EB05 9.4 · IC025 +3.2 3/3 methods agree vs other Loop Diuretics: PRR 10.2 (9.4–11.0) | Labeled (related wording) related wording | serious PRR 6.8 | no trial arm names this drug |
| Haemorrhagic anaemia | 806 | 11.4 10.6–12.3ROR 11.4 · calibrated p 0.020 ✓ | 9.5 EB05 8.9 · IC025 +3.1 3/3 methods agree vs other Loop Diuretics: PRR 19.7 (16.0–24.4) | Not in label — unassessed | serious n=805 | no trial arm names this drug |
| Right ventricular failure | 1,267 | 11.3 10.6–12.0ROR 11.3 · calibrated p 0.021 ✓ | 9.4 EB05 9.0 · IC025 +3.1 3/3 methods agree vs other Loop Diuretics: PRR 8.3 (7.4–9.3) | Not in label — unassessed | serious PRR 6.7 | no trial arm names this drug |
| Hyperkalaemia (high potassium) | 5,819 | 10.4 10.1–10.7ROR 10.5 · calibrated p 0.027 ✓ | 8.8 EB05 8.6 · IC025 +3.1 3/3 methods agree vs other Loop Diuretics: PRR 16.9 (15.8–18.2) | Not in label — unassessed | age-adj. PRR 6.6 · serious PRR 6.3 | no trial arm names this drug |
| Rales | 923 | 9.8 9.1–10.5ROR 9.8 · calibrated p 0.035 ✓ | 8.3 EB05 7.9 · IC025 +2.9 3/3 methods agree vs other Loop Diuretics: PRR 13.4 (11.3–15.8) | Not in label — unassessed | serious n=900 | no trial arm names this drug |
| Diastolic dysfunction | 491 | 9.7 8.8–10.7ROR 9.7 · calibrated p 0.036 ✓ | 8.3 EB05 7.7 · IC025 +2.9 3/3 methods agree vs other Loop Diuretics: PRR 10.0 (8.2–12.2) | Not in label — unassessed | serious n=478 | no trial arm names this drug |
| Hypovolaemia | 884 | 9.2 8.6–9.9ROR 9.2 · calibrated p 0.042 ✓ | 7.9 EB05 7.5 · IC025 +2.9 3/3 methods agree vs other Loop Diuretics: PRR 15.1 (12.6–18.1) | Not in label — unassessed | serious n=873 | no trial arm names this drug |
| Cardiac failure congestive | 12,088 | 9.1 8.9–9.2ROR 9.3 · calibrated p 0.041 ✓ | 7.8 EB05 7.7 · IC025 +2.9 3/3 methods agree vs other Loop Diuretics: PRR 16.4 (15.6–17.2) | Not in label — unassessed | age-adj. PRR 7.2 · serious PRR 5.6 | no trial arm names this drug |
| Dilatation ventricular | 310 | 8.8 7.8–10.0ROR 8.8 · calibrated p 0.049 ✓ | 7.6 EB05 6.9 · IC025 +2.7 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=310 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Left ventricular failure | 493 | 8.7 7.9–9.6ROR 8.7 · calibrated p 0.051 | 7.6 EB05 7.0 · IC025 +2.8 3/3 methods agree vs other Loop Diuretics: PRR 8.2 (6.8–9.9) | Not in label — unassessed | serious n=488 | no trial arm names this drug |
| Renal failure chronic | 1,118 | 8.7 8.1–9.2ROR 8.7 · calibrated p 0.052 | 7.5 EB05 7.2 · IC025 +2.8 3/3 methods agree vs other Loop Diuretics: PRR 17.5 (14.8–20.7) | Likely indication confounding term in indications | serious PRR 5.4 | no trial arm names this drug |
| Cardiac failure acute | 952 | 8.6 8.1–9.3ROR 8.7 · calibrated p 0.052 | 7.5 EB05 7.1 · IC025 +2.8 3/3 methods agree vs other Loop Diuretics: PRR 7.7 (6.7–8.7) | Not in label — unassessed | serious n=950 | no trial arm names this drug |
| Mitral valve incompetence | 1,615 | 8.6 8.2–9.1ROR 8.6 · calibrated p 0.052 | 7.5 EB05 7.2 · IC025 +2.8 3/3 methods agree vs other Loop Diuretics: PRR 12.4 (11.0–14.0) | Not in label — unassessed | age-adj. PRR 6.8 · serious PRR 5.3 | no trial arm names this drug |
| Therapeutic agent toxicity | 482 | 8.6 7.8–9.5ROR 8.6 · calibrated p 0.053 | 7.5 EB05 6.9 · IC025 +2.7 3/3 methods agree vs other Loop Diuretics: PRR 28.6 (20.7–39.5) | Not in label — unassessed | serious n=478 · 100% clinician | no trial arm names this drug |
| Aortic stenosis | 494 | 8.5 7.8–9.4ROR 8.6 · calibrated p 0.054 | 7.4 EB05 6.9 · IC025 +2.7 3/3 methods agree vs other Loop Diuretics: PRR 16.1 (12.6–20.6) | Not in label — unassessed | serious n=492 | no trial arm names this drug |
| Pulmonary hypertension | 2,960 | 8.5 8.2–8.9ROR 8.6 · calibrated p 0.053 | 7.4 EB05 7.2 · IC025 +2.8 3/3 methods agree vs other Loop Diuretics: PRR 9.1 (8.4–9.9) | Not in label — unassessed | age-adj. PRR 7.2 · serious PRR 5.3 | no trial arm names this drug |
| Blood urea increased | 2,358 | 8.4 8.1–8.8ROR 8.5 · calibrated p 0.056 | 7.4 EB05 7.1 · IC025 +2.8 3/3 methods agree vs other Loop Diuretics: PRR 14.1 (12.7–15.6) | Lab value / disease marker | age-adj. PRR 5.7 · serious PRR 5.6 | no trial arm names this drug |
| Hypervolaemia | 656 | 8.2 7.5–8.9ROR 8.2 · calibrated p 0.062 | 7.2 EB05 6.7 · IC025 +2.7 3/3 methods agree vs other Loop Diuretics: PRR 4.4 (3.9–5.0) | Not in label — unassessed | serious n=635 | no trial arm names this drug |
| Left ventricular hypertrophy | 572 | 8.0 7.3–8.7ROR 8.0 · calibrated p 0.068 | 7.0 EB05 6.5 · IC025 +2.7 3/3 methods agree vs other Loop Diuretics: PRR 10.7 (8.8–13.0) | Not in label — unassessed | serious n=566 | no trial arm names this drug |
| Orthostatic hypotension (dizziness on standing) | 2,320 | 7.9 7.6–8.3ROR 8.0 · calibrated p 0.067 | 7.0 EB05 6.8 · IC025 +2.7 3/3 methods agree vs other Loop Diuretics: PRR 26.1 (22.7–30.1) | Labeled adverse reaction exact term | serious PRR 5.5 | no trial arm names this drug |
| Tricuspid valve incompetence | 1,050 | 7.9 7.4–8.5ROR 7.9 · calibrated p 0.068 | 7.0 EB05 6.6 · IC025 +2.7 3/3 methods agree vs other Loop Diuretics: PRR 9.1 (8.0–10.4) | Not in label — unassessed | serious PRR 5.0 | no trial arm names this drug |
| International normalised ratio increased | 3,799 | 7.9 7.6–8.1ROR 7.9 · calibrated p 0.068 | 6.9 EB05 6.8 · IC025 +2.7 3/3 methods agree vs other Loop Diuretics: PRR 20.3 (18.4–22.4) | Lab value / disease marker | age-adj. PRR 5.0 · serious PRR 5.3 | no trial arm names this drug |
| Cardiomegaly | 1,626 | 7.8 7.4–8.2ROR 7.8 · calibrated p 0.071 | 6.9 EB05 6.6 · IC025 +2.7 3/3 methods agree vs other Loop Diuretics: PRR 16.7 (14.6–19.2) | Not in label — unassessed | age-adj. PRR 6.8 · serious PRR 5.0 | no trial arm names this drug |
| Renal failure acute | 5,597 | 7.7 7.5–8.0ROR 7.8 · calibrated p 0.071 | 6.8 EB05 6.7 · IC025 +2.7 3/3 methods agree vs other Loop Diuretics: PRR 17.9 (16.6–19.3) | Likely indication confounding term in indications | age-adj. PRR 5.4 · serious PRR 4.9 | no trial arm names this drug |
| Bundle branch block left | 548 | 7.6 7.0–8.3ROR 7.6 · calibrated p 0.077 | 6.7 EB05 6.3 · IC025 +2.6 3/3 methods agree vs other Loop Diuretics: PRR 16.7 (13.2–21.2) | Not in label — unassessed | serious n=549 | no trial arm names this drug |
| Congestive cardiomyopathy | 536 | 7.5 6.9–8.2ROR 7.5 · calibrated p 0.081 | 6.6 EB05 6.2 · IC025 +2.6 3/3 methods agree vs other Loop Diuretics: PRR 16.1 (12.7–20.4) | Not in label — unassessed | serious n=533 | 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 |
|---|---|---|---|
| Heart failure | 23,492 | 7.87.7–7.9 | signal |
| Kidney injury | 43,869 | 5.55.4–5.5 | signal |
| Hyponatraemia | 7,171 | 5.14.9–5.2 | signal |
| Gi bleeding | 13,933 | 4.34.2–4.3 | signal |
| Arrhythmia / qt | 14,300 | 4.14.1–4.2 | signal |
| Anaemia | 18,439 | 3.43.3–3.4 | signal |
| Hypoglycaemia | 4,811 | 2.72.7–2.8 | signal |
| Rhabdomyolysis / myopathy | 3,979 | 2.72.6–2.8 | signal |
| Fall / fracture | 17,435 | 2.52.4–2.5 | signal |
| Myocardial infarction | 9,157 | 2.42.4–2.5 | signal |
| Serious infection | 33,825 | 2.42.3–2.4 | signal |
| Severe cutaneous reaction | 3,232 | 2.32.3–2.4 | signal |
| Thrombocytopenia | 9,350 | 2.32.2–2.3 | signal |
| Interstitial lung disease | 3,959 | 2.22.2–2.3 | signal |
| Stroke | 8,542 | 1.81.8–1.9 | raised |
| Venous thromboembolism | 7,183 | 1.81.7–1.8 | raised |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Furosemide only as a background or rescue medication (NCT00535925, NCT00000620); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 29,963 | 2.9 2.9–2.9ROR 3.0 · calibrated p 0.612 | 2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Loop Diuretics: PRR 11.6 (11.3–11.8) | Not in label — unassessed | age-adj. PRR 2.4 · serious PRR 2.3 | no trial arm names this drug |
| Fatigue (tiredness) | 21,056 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.617 | 1.4 EB05 1.4 · IC025 +0.5 vs other Loop Diuretics: PRR 12.8 (12.4–13.2) | Not in label — unassessed | age-adj. PRR 1.2 · serious PRR 1.4 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 20,617 | 1.7 1.7–1.7ROR 1.7 · calibrated p 0.799 | 1.7 EB05 1.7 · IC025 +0.7 vs other Loop Diuretics: PRR 13.5 (13.0–13.9) | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.6 | no trial arm names this drug |
| Nausea | 19,260 | 1.3 1.3–1.3ROR 1.3 · calibrated p 0.513 | 1.3 EB05 1.3 · IC025 +0.3 vs other Loop Diuretics: PRR 12.8 (12.4–13.2) | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.3 | no trial arm names this drug |
| Acute kidney injury (sudden kidney damage) | 19,011 | 7.4 7.3–7.5ROR 7.7 · calibrated p 0.075 | 6.6 EB05 6.5 · IC025 +2.7 3/3 methods agree vs other Loop Diuretics: PRR 13.0 (12.6–13.4) | Labeled (related wording) related wording | age-adj. PRR 4.9 · serious PRR 4.7 | no trial arm names this drug |
| Death | 18,743 | 1.1 1.1–1.2ROR 1.2 · calibrated p 0.410 | 1.1 EB05 1.1 · IC025 +0.2 vs other Loop Diuretics: PRR 13.0 (12.6–13.5) | Outcome field, not a reaction | age-adj. PRR 1.0 · serious PRR 0.8 | no trial arm names this drug |
| Fall | 16,517 | 2.7 2.7–2.7ROR 2.8 · calibrated p 0.704 | 2.6 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Loop Diuretics: PRR 15.3 (14.7–15.9) | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 2.1 | no trial arm names this drug |
| Pneumonia (lung infection) | 16,482 | 2.8 2.7–2.8ROR 2.9 · calibrated p 0.676 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Loop Diuretics: PRR 15.7 (15.1–16.3) | Not in label — unassessed | age-adj. PRR 2.1 · serious PRR 2.0 | no trial arm names this drug |
| Asthenia (weakness) | 15,485 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.918 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Loop Diuretics: PRR 15.4 (14.8–16.0) | Not in label — unassessed | age-adj. PRR 1.7 · serious PRR 1.9 | no trial arm names this drug |
| Dizziness | 15,212 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.740 | 1.6 EB05 1.6 · IC025 +0.7 vs other Loop Diuretics: PRR 11.2 (10.8–11.6) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.5 | no trial arm names this drug |
| Hypotension (low blood pressure) | 15,153 | 4.2 4.2–4.3ROR 4.4 · calibrated p 0.317 | 4.0 EB05 3.9 · IC025 +2.0 3/3 methods agree vs other Loop Diuretics: PRR 14.2 (13.7–14.8) | Labeled adverse reaction exact term | age-adj. PRR 3.3 · serious PRR 3.0 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 14,879 | 0.6 0.6–0.6ROR 0.6 · calibrated p 0.074 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC vs other Loop Diuretics: PRR 19.9 (19.0–20.8) | Reporting / coding artifact | age-adj. PRR 0.7 · serious PRR 0.8 | no trial arm names this drug |
| Off label use (used outside approved label) | 14,779 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.237 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Loop Diuretics: PRR 17.3 (16.6–18.1) | Reporting / coding artifact | age-adj. PRR 0.8 · serious PRR 1.0 | no trial arm names this drug |
| Pain | 13,913 | 1.2 1.2–1.2ROR 1.2 · calibrated p 0.441 | 1.2 EB05 1.2 · IC025 +0.2 vs other Loop Diuretics: PRR 15.2 (14.6–15.9) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.1 | no trial arm names this drug |
| Headache | 13,589 | 1.1 1.1–1.2ROR 1.2 · calibrated p 0.407 | 1.1 EB05 1.1 · IC025 +0.2 vs other Loop Diuretics: PRR 11.7 (11.2–12.1) | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 1.1 | 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.
- Hyperparathyroidism secondary — n=895, PRR 28.4
- Chronic kidney disease-mineral and bone disorder — n=367, PRR 26.9
- Orthopnoea — n=751, PRR 15.9
- Cardiac failure chronic — n=996, PRR 15.8
- Rebound acid hypersecretion — n=701, PRR 15.4
- Left atrial dilatation — n=264, PRR 13.4
- Ischaemic cardiomyopathy — n=584, PRR 12.0
- Haemorrhagic anaemia — n=806, PRR 11.4
- Right ventricular failure — n=1,267, PRR 11.3
- Hyperkalaemia — n=5,819, PRR 10.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Furosemide (loop diuretics) ↔ Hypokalaemia.
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 Furosemide?
In FDA FAERS, the most frequently co-reported reaction terms for Furosemide are dyspnoea, fatigue, diarrhoea, nausea, acute kidney injury, fall. 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 Furosemide have an FDA boxed warning?
No. The FDA label retrieved for Furosemide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Furosemide 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 08a44bdd-028d-41af-9d4e-70971b0bcc4e, effective 20260109; matched on
openfda.generic_name.exact:"FUROSEMIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 3440 description (ChEBI)
- 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, 1,203 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
FUROSEMIDE, 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.