Drug · FAERS side-effect profile with label screen
Torsemide side effects: what 32,883 FDA adverse event reports show
Who reports
32,883 reports · 81% serious · 4,435 with death outcome · 54% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Torsemide is a loop diuretic indicated for: the treatment of edema associated with heart failure, renal disease or hepatic disease. ( 1.1 ) the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
FDA label, Indications and Usage
What it is
Torsemide, USP is a diuretic of the pyridine-sulfonylurea class.
FDA label, Description section
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 (related wording) 1Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 33
What the badges mean
- 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). 1,215 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 |
|---|---|---|---|---|---|---|
| Femoral hernia incarcerated | 33 | 530.9 334.0–843.8ROR 531.4 · calibrated p 5e-13 ✓ | 246.9 EB05 184.0 · IC025 +5.2 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=33 · ♀ 100% (drug 54%) · 100% clinician | not reported in cached trials |
| Therapeutic drug monitoring analysis incorrectly performed | 32 | 318.7 208.3–487.6ROR 319.0 · calibrated p 4e-11 ✓ | 188.1 EB05 139.5 · IC025 +5.1 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=32 · ♀ 0% (drug 54%) · 100% clinician | not reported in cached trials |
| Lymphatic fistula | 32 | 299.6 196.7–456.5ROR 299.9 · calibrated p 6e-11 ✓ | 181.3 EB05 134.4 · IC025 +5.0 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=32 · ♀ 100% (drug 54%) · 100% clinician | not reported in cached trials |
| Vena cava injury | 27 | 277.7 176.5–436.8ROR 277.9 · calibrated p 2e-10 ✓ | 169.8 EB05 122.6 · IC025 +4.8 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=27 · ♀ 0% (drug 54%) | not reported in cached trials |
| Neuroglycopenia | 28 | 222.4 144.5–342.2ROR 222.6 · calibrated p 9e-10 ✓ | 148.0 EB05 107.5 · IC025 +4.8 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=28 · ♀ 100% (drug 54%) · 100% clinician | not reported in cached trials |
| Therapeutic drug monitoring analysis not performed | 73 | 207.2 159.1–269.9ROR 207.7 · calibrated p 5e-10 ✓ | 150.0 EB05 123.3 · IC025 +5.9 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=73 · 100% clinician | not reported in cached trials |
| Product monitoring error | 295 | 165.1 145.3–187.6ROR 166.6 · calibrated p 2e-9 ✓ | 129.8 EB05 117.9 · IC025 +6.6 3/3 methods agree vs other Loop Diuretics: only this drug | Reporting / coding artifact | serious n=295 · 100% clinician | not reported in cached trials |
| Ventricular enlargement | 36 | 163.7 113.4–236.2ROR 163.8 · calibrated p 7e-9 ✓ | 121.8 EB05 91.9 · IC025 +5.0 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=36 · ♀ 0% (drug 54%) · 100% clinician | not reported in cached trials |
| Truncus arteriosus persistent | 40 | 157.8 111.6–223.2ROR 158.0 · calibrated p 8e-9 ✓ | 119.2 EB05 91.3 · IC025 +5.1 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=40 · 100% clinician | not reported in cached trials |
| Systemic infection | 275 | 126.2 110.9–143.6ROR 127.3 · calibrated p 2e-8 ✓ | 104.5 EB05 94.5 · IC025 +6.3 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=275 · 100% clinician | not reported in cached trials |
| Renal cyst haemorrhage | 34 | 116.6 80.8–168.1ROR 116.7 · calibrated p 9e-8 ✓ | 93.4 EB05 69.9 · IC025 +4.8 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=34 · ♀ 0% (drug 54%) | not reported in cached trials |
| Pancreatic steatosis | 41 | 115.9 83.1–161.7ROR 116.0 · calibrated p 8e-8 ✓ | 93.8 EB05 72.1 · IC025 +5.0 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=41 · ♀ 100% (drug 54%) · 100% clinician | not reported in cached trials |
| Peripheral circulatory failure | 42 | 72.8 52.9–100.2ROR 72.9 · calibrated p 2e-6 ✓ | 63.5 EB05 49.0 · IC025 +4.7 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=42 · ♀ 100% (drug 54%) · 100% clinician | not reported in cached trials |
| Wound infection pseudomonas | 31 | 70.2 48.4–101.8ROR 70.3 · calibrated p 3e-6 ✓ | 61.0 EB05 45.0 · IC025 +4.4 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=31 · ♀ 100% (drug 54%) · 100% clinician | not reported in cached trials |
| Abdominal wall haemorrhage | 25 | 68.2 45.1–103.0ROR 68.2 · calibrated p 4e-6 ✓ | 59.0 EB05 42.0 · IC025 +4.1 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=25 · ♀ 0% (drug 54%) · 100% clinician | not reported in cached trials |
| Low cardiac output syndrome | 28 | 58.2 39.5–85.7ROR 58.2 · calibrated p 1e-5 ✓ | 51.6 EB05 37.4 · IC025 +4.2 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=28 · ♀ 0% (drug 54%) · 100% clinician | not reported in cached trials |
| Helicobacter test positive | 40 | 49.1 35.6–67.7ROR 49.2 · calibrated p 2e-5 ✓ | 44.7 EB05 34.2 · IC025 +4.4 3/3 methods agree vs other Loop Diuretics: only this drug | Lab value / disease marker | serious n=40 · ♀ 0% (drug 54%) | not reported in cached trials |
| Multiple drug therapy | 50 | 49.1 36.8–65.5ROR 49.2 · calibrated p 2e-5 ✓ | 44.9 EB05 35.4 · IC025 +4.5 3/3 methods agree vs other Loop Diuretics: only this drug | Reporting / coding artifact | serious n=50 · ♀ 100% (drug 54%) · 100% clinician | not reported in cached trials |
| Orthostatic intolerance | 44 | 41.8 30.8–56.7ROR 41.9 · calibrated p 6e-5 ✓ | 38.7 EB05 30.0 · IC025 +4.3 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=43 | not reported in cached trials |
| Delayed graft function | 42 | 40.2 29.4–54.9ROR 40.2 · calibrated p 7e-5 ✓ | 37.2 EB05 28.7 · IC025 +4.2 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=42 · ♀ 0% (drug 54%) | not reported in cached trials |
| Hyperparathyroidism secondary | 149 | 39.8 33.7–46.9ROR 40.0 · calibrated p 6e-5 ✓ | 37.3 EB05 32.5 · IC025 +4.8 3/3 methods agree vs other Loop Diuretics: PRR 0.4 (0.3–0.4) | Not in label — unassessed | serious n=149 · 100% clinician | not reported in cached trials |
| Left atrial enlargement | 31 | 39.3 27.3–56.5ROR 39.3 · calibrated p 1e-4 ✓ | 36.3 EB05 26.8 · IC025 +4.0 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=31 · ♀ 0% (drug 54%) · 100% clinician | not reported in cached trials |
| Respiratory tract haemorrhage | 33 | 37.2 26.2–52.8ROR 37.2 · calibrated p 1e-4 ✓ | 34.5 EB05 25.7 · IC025 +4.0 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=33 · ♀ 0% (drug 54%) · 100% clinician | not reported in cached trials |
| Cardiac septal defect | 39 | 36.2 26.2–50.0ROR 36.2 · calibrated p 1e-4 ✓ | 33.8 EB05 25.8 · IC025 +4.1 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=39 · 100% clinician | not reported in cached trials |
| N-terminal prohormone brain natriuretic peptide increased | 74 | 35.4 28.0–44.8ROR 35.5 · calibrated p 1e-4 ✓ | 33.3 EB05 27.4 · IC025 +4.4 3/3 methods agree vs other Loop Diuretics: PRR 0.5 (0.4–0.6) | Lab value / disease marker | serious n=73 · ♀ 32% (drug 54%) | not reported in cached trials |
| Aortic dilatation | 54 | 33.1 25.2–43.5ROR 33.2 · calibrated p 2e-4 ✓ | 31.2 EB05 24.8 · IC025 +4.2 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=54 · ♀ 0% (drug 54%) | not reported in cached trials |
| Congenital cardiovascular anomaly | 41 | 32.2 23.6–44.1ROR 32.3 · calibrated p 2e-4 ✓ | 30.3 EB05 23.3 · IC025 +4.0 3/3 methods agree vs other Loop Diuretics: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=41 · 100% clinician | not reported in cached trials |
| Osteochondrosis | 56 | 32.0 24.4–41.8ROR 32.0 · calibrated p 2e-4 ✓ | 30.2 EB05 24.1 · IC025 +4.2 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=56 · ♀ 33% (drug 54%) | not reported in cached trials |
| Device maintenance issue | 27 | 32.0 21.7–47.0ROR 32.0 · calibrated p 3e-4 ✓ | 29.9 EB05 21.6 · IC025 +3.7 3/3 methods agree vs other Loop Diuretics: PRR 1.9 (1.1–3.1) | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 51 | 31.6 23.9–41.9ROR 31.7 · calibrated p 3e-4 ✓ | 29.9 EB05 23.6 · IC025 +4.1 3/3 methods agree vs other Loop Diuretics: PRR 0.3 (0.2–0.4) | Not in label — unassessed | serious n=51 | not reported in cached trials |
| Cardiac failure chronic | 199 | 31.2 27.1–36.0ROR 31.4 · calibrated p 2e-4 ✓ | 29.7 EB05 26.4 · IC025 +4.6 3/3 methods agree vs other Loop Diuretics: PRR 0.4 (0.4–0.5) | Labeled (related wording) related wording | serious n=199 · ♀ 28% (drug 54%) | not reported in cached trials |
| Carotid arteriosclerosis | 44 | 28.5 21.1–38.6ROR 28.6 · calibrated p 5e-4 ✓ | 27.1 EB05 21.0 · IC025 +3.9 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=44 · ♀ 0% (drug 54%) | not reported in cached trials |
| Nephrogenic anaemia | 198 | 28.1 24.4–32.4ROR 28.3 · calibrated p 4e-4 ✓ | 26.9 EB05 23.9 · IC025 +4.4 3/3 methods agree vs other Loop Diuretics: PRR 0.2 (0.2–0.3) | Not in label — unassessed | serious n=198 | not reported in cached trials |
| Renal artery stenosis | 58 | 27.8 21.4–36.1ROR 27.8 · calibrated p 5e-4 ✓ | 26.4 EB05 21.2 · IC025 +4.0 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=58 | not reported in cached trials |
| Arterial haemorrhage | 48 | 27.7 20.8–37.0ROR 27.8 · calibrated p 5e-4 ✓ | 26.4 EB05 20.7 · IC025 +3.9 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=48 · ♀ 100% (drug 54%) · 100% clinician | not reported in cached trials |
| Stasis dermatitis | 28 | 27.1 18.5–39.5ROR 27.1 · calibrated p 7e-4 ✓ | 25.6 EB05 18.6 · IC025 +3.5 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=26 | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 56 | 26.6 20.3–34.7ROR 26.6 · calibrated p 6e-4 ✓ | 25.3 EB05 20.2 · IC025 +3.9 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=55 | not reported in cached trials |
| Hypochromic anaemia | 39 | 25.4 18.5–35.0ROR 25.5 · calibrated p 8e-4 ✓ | 24.2 EB05 18.5 · IC025 +3.7 3/3 methods agree vs other Loop Diuretics: only this drug | Not in label — unassessed | serious n=39 · ♀ 0% (drug 54%) · 100% clinician | not reported in cached trials |
| Cardiac amyloidosis | 41 | 24.9 18.2–34.0ROR 25.0 · calibrated p 9e-4 ✓ | 23.8 EB05 18.3 · IC025 +3.7 3/3 methods agree vs other Loop Diuretics: PRR 3.5 (2.2–5.6) | Not in label — unassessed | serious n=41 · ♀ 0% (drug 54%) | not reported in cached trials |
| Hypervolaemia | 177 | 24.4 21.0–28.3ROR 24.5 · calibrated p 8e-4 ✓ | 23.4 EB05 20.7 · IC025 +4.2 3/3 methods agree vs other Loop Diuretics: PRR 0.5 (0.4–0.6) | Not in label — unassessed | serious n=166 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Torsemide 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).
- NCT02813551 — ToRsemide for pOstpartum HYpertension (N=118, PHASE2; 2 AE terms posted; arms: Torsemide; Placebo)
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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 3,502 | 4.0 3.8–4.1ROR 4.3 · calibrated p 0.324 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other Loop Diuretics: PRR 0.3 (0.2–0.3) | Not in label — unassessed | serious PRR 3.4 | not reported in cached trials |
| Fatigue (tiredness) | 2,186 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.860 | 1.8 EB05 1.7 · IC025 +0.8 vs other Loop Diuretics: PRR 0.2 (0.2–0.2) | Not in label — unassessed | serious PRR 1.8 | not reported in cached trials |
| Diarrhoea (diarrhea) | 2,063 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.994 | 2.0 EB05 2.0 · IC025 +1.0 vs other Loop Diuretics: PRR 0.2 (0.2–0.2) | Not in label — unassessed | serious PRR 1.9 | not reported in cached trials |
| Nausea | 2,034 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.760 | 1.6 EB05 1.6 · IC025 +0.6 vs other Loop Diuretics: PRR 0.2 (0.2–0.2) | Not in label — unassessed | serious PRR 1.7 | not reported in cached trials |
| Dizziness | 1,934 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.783 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Loop Diuretics: PRR 0.3 (0.3–0.3) | Not in label — unassessed | serious PRR 2.5 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 1,789 | 7.6 7.2–7.9ROR 7.9 · calibrated p 0.068 | 7.5 EB05 7.2 · IC025 +2.8 3/3 methods agree vs other Loop Diuretics: PRR 0.2 (0.2–0.2) | Labeled (related wording) related wording | serious PRR 5.3 | not reported in cached trials |
| Death | 1,720 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.499 | 1.3 EB05 1.2 · IC025 +0.3 vs other Loop Diuretics: PRR 0.2 (0.2–0.2) | Outcome field, not a reaction | serious PRR 0.9 | not reported in cached trials |
| General physical health deterioration | 1,649 | 9.3 8.8–9.7ROR 9.7 · calibrated p 0.036 ✓ | 9.1 EB05 8.8 · IC025 +3.1 3/3 methods agree vs other Loop Diuretics: PRR 1.0 (0.9–1.0) | Reporting / coding artifact | serious PRR 7.6 · 92% clinician | not reported in cached trials |
| Fall | 1,625 | 3.1 3.0–3.3ROR 3.2 · calibrated p 0.555 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Loop Diuretics: PRR 0.2 (0.2–0.2) | Not in label — unassessed | serious PRR 2.5 | not reported in cached trials |
| Oedema peripheral (swelling of legs/feet) | 1,586 | 8.4 8.0–8.8ROR 8.7 · calibrated p 0.051 | 8.2 EB05 7.9 · IC025 +3.0 3/3 methods agree vs other Loop Diuretics: PRR 0.3 (0.3–0.3) | Not in label — unassessed | serious PRR 7.4 | not reported in cached trials |
| Headache | 1,520 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.690 | 1.5 EB05 1.5 · IC025 +0.5 vs other Loop Diuretics: PRR 0.2 (0.2–0.3) | Not in label — unassessed | serious PRR 1.5 | not reported in cached trials |
| Hypotension (low blood pressure) | 1,479 | 4.7 4.5–5.0ROR 4.9 · calibrated p 0.245 | 4.7 EB05 4.5 · IC025 +2.1 3/3 methods agree vs other Loop Diuretics: PRR 0.2 (0.2–0.2) | Labeled adverse reaction exact term | serious PRR 3.5 | not reported in cached trials |
| Anaemia (low red blood cells) | 1,445 | 4.9 4.6–5.1ROR 5.0 · calibrated p 0.232 | 4.8 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Loop Diuretics: PRR 0.3 (0.2–0.3) | Labeled adverse reaction exact term | serious PRR 3.7 | not reported in cached trials |
| Cardiac failure (heart failure) | 1,385 | 11.2 10.6–11.7ROR 11.6 · calibrated p 0.019 ✓ | 11.0 EB05 10.5 · IC025 +3.4 3/3 methods agree vs other Loop Diuretics: PRR 0.3 (0.3–0.3) | Labeled (related wording) related wording | serious PRR 7.8 | not reported in cached trials |
| Pneumonia (lung infection) | 1,362 | 2.7 2.6–2.8ROR 2.8 · calibrated p 0.708 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree vs other Loop Diuretics: PRR 0.2 (0.2–0.2) | Not in label — unassessed | serious PRR 2.0 | 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.
- Femoral hernia incarcerated — n=33, PRR 530.9
- Therapeutic drug monitoring analysis incorrectly performed — n=32, PRR 318.7
- Lymphatic fistula — n=32, PRR 299.6
- Vena cava injury — n=27, PRR 277.7
- Neuroglycopenia — n=28, PRR 222.4
- Therapeutic drug monitoring analysis not performed — n=73, PRR 207.2
- Ventricular enlargement — n=36, PRR 163.7
- Truncus arteriosus persistent — n=40, PRR 157.8
- Systemic infection — n=275, PRR 126.2
- Renal cyst haemorrhage — n=34, PRR 116.6
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 Torsemide?
In FDA FAERS, the most frequently co-reported reaction terms for Torsemide are dyspnoea, fatigue, diarrhoea, nausea, dizziness, acute kidney injury. 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 Torsemide have an FDA boxed warning?
No. The FDA label retrieved for Torsemide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Torsemide 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 03fbbb85-4e0f-4f3b-b4b0-87f84cb33d47, effective 20230630; matched on
openfda.generic_name.exact:"TORSEMIDE") - 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, 1,255 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
TORSEMIDE, 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.