Drug · FAERS side-effect profile with label screen
Valsartan side effects: what 104,469 FDA adverse event reports show
Drug class
Angiotensin 2 Receptor Blocker
FDA label (Established Pharmacologic Class) · compare the class
Who reports
104,469 reports · 76% serious · 9,543 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: • Hypertension , to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primar.
FDA label, Indications and Usage
What it is
Valsartan is a monocarboxylic acid amide consisting of L-valine in which the amino hydrogens have been replaced by a pentanoyl and a [2'-(1H-tetrazol-5-yl)biphenyl]-4-yl]methyl group.
PubChem CID 60846 (ChEBI)
Boxed warning
FETAL TOXICITY WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue valsartan tablets as soon as possible. (5.1) • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
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 1Labeled (related wording) 2Likely indication confounding 5Not in label — unassessed 30
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.
- 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). 1,155 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 |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 124 | 137.3 109.1–172.6ROR 137.4 · calibrated p 1e-8 ✓ | 80.3 EB05 69.2 · IC025 +5.6 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 9.7 (7.5–12.4) | Not in label — unassessed | serious n=124 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Blood pressure inadequately controlled | 795 | 30.2 28.0–32.5ROR 30.4 · calibrated p 2e-4 ✓ | 26.3 EB05 24.8 · IC025 +4.6 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 16.1 (14.4–18.1) | Labeled (related wording) related wording | serious n=710 | not reported in cached trials |
| Physical deconditioning | 272 | 24.4 21.5–27.6ROR 24.4 · calibrated p 8e-4 ✓ | 21.8 EB05 19.7 · IC025 +4.2 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 8.5 (7.2–10.0) | Not in label — unassessed | serious n=272 | not reported in cached trials |
| Foetal disorder | 87 | 22.9 18.4–28.6ROR 23.0 · calibrated p 0.001 ✓ | 20.6 EB05 17.2 · IC025 +3.9 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 9.8 (7.3–13.2) | Labeled (related wording) related wording | serious n=86 · 100% clinician | not reported in cached trials |
| Nephrogenic anaemia | 433 | 20.4 18.5–22.5ROR 20.5 · calibrated p 0.002 ✓ | 18.6 EB05 17.1 · IC025 +4.0 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 12.9 (11.2–14.9) | Not in label — unassessed | serious n=432 | not reported in cached trials |
| Hyperparathyroidism secondary | 215 | 18.5 16.1–21.3ROR 18.6 · calibrated p 0.003 ✓ | 17.0 EB05 15.2 · IC025 +3.8 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 13.5 (11.0–16.6) | Not in label — unassessed | serious n=214 | NCT00097786: 1/2,297 (0.0%) on Valsartan; 1/2,283 (0.0%) control (serious AE) |
| Oligohydramnios | 270 | 17.5 15.5–19.8ROR 17.6 · calibrated p 0.004 ✓ | 16.1 EB05 14.6 · IC025 +3.8 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 9.8 (8.3–11.6) | Labeled — boxed warning exact term | serious n=268 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Fear of disease | 144 | 17.4 14.7–20.6ROR 17.4 · calibrated p 0.004 ✓ | 16.0 EB05 13.9 · IC025 +3.7 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 10.3 (8.2–13.0) | Not in label — unassessed | serious n=143 | not reported in cached trials |
| Female genital tract fistula | 136 | 17.1 14.4–20.4ROR 17.2 · calibrated p 0.004 ✓ | 15.8 EB05 13.7 · IC025 +3.6 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 9.7 (7.7–12.4) | Not in label — unassessed | serious n=136 · ♀ 100% (drug 59%) · 100% clinician | NCT00097786: 1/2,297 (0.0%) on Valsartan (serious AE) |
| Chronic kidney disease-mineral and bone disorder | 84 | 16.9 13.5–21.1ROR 16.9 · calibrated p 0.005 ✓ | 15.6 EB05 13.0 · IC025 +3.5 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: only this drug | Not in label — unassessed | serious n=84 · ♀ 0% (drug 59%) | not reported in cached trials |
| Macular degeneration | 910 | 16.5 15.4–17.7ROR 16.7 · calibrated p 0.005 ✓ | 15.3 EB05 14.5 · IC025 +3.8 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 9.1 (8.3–9.9) | Not in label — unassessed | serious PRR 12.4 · ♀ 95% (drug 59%) | NCT00097786: 1/2,316 (0.0%) on Valsartan; 1/2,305 (0.0%) control (serious AE) |
| Multi-organ disorder | 144 | 15.6 13.2–18.5ROR 15.6 · calibrated p 0.006 ✓ | 14.5 EB05 12.6 · IC025 +3.5 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 10.2 (8.0–12.8) | Not in label — unassessed | serious n=141 · ♀ 100% (drug 59%) | NCT00097786: 2/2,305 (0.1%) on Valsartan; 4/2,283 (0.2%) control (serious AE) |
| Osteochondrosis | 80 | 14.7 11.7–18.4ROR 14.7 · calibrated p 0.008 ✓ | 13.6 EB05 11.2 · IC025 +3.3 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 9.8 (7.2–13.4) | Not in label — unassessed | serious n=80 · ♀ 0% (drug 59%) · 100% consumer | NCT00097786: 1/2,305 (0.0%) on Valsartan; 3/2,283 (0.1%) control (serious AE) |
| Rhonchi | 91 | 14.0 11.4–17.4ROR 14.1 · calibrated p 0.010 ✓ | 13.1 EB05 10.9 · IC025 +3.3 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 11.7 (8.6–15.9) | Not in label — unassessed | serious n=91 · ♀ 100% (drug 59%) | not reported in cached trials |
| Radiculopathy | 161 | 13.0 11.1–15.2ROR 13.0 · calibrated p 0.013 ✓ | 12.2 EB05 10.7 · IC025 +3.3 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 9.7 (7.8–12.0) | Not in label — unassessed | serious n=162 · ♀ 100% (drug 59%) | NCT00097786: 1/2,305 (0.0%) on Valsartan; 2/2,283 (0.1%) control (serious AE) |
| Renal artery stenosis | 82 | 12.6 10.1–15.7ROR 12.6 · calibrated p 0.015 ✓ | 11.7 EB05 9.7 · IC025 +3.1 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: only this drug | Labeled adverse reaction exact term | serious n=81 · 100% clinician | NCT00097786: 1/2,305 (0.0%) on Valsartan; 1/2,283 (0.0%) control (serious AE) |
| Chronic sinusitis | 219 | 12.4 10.8–14.2ROR 12.4 · calibrated p 0.015 ✓ | 11.7 EB05 10.4 · IC025 +3.3 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 8.4 (7.0–10.0) | Not in label — unassessed | serious n=214 · ♀ 100% (drug 59%) | NCT00097786: 1/2,297 (0.0%) on Valsartan (serious AE) |
| Brash syndrome | 73 | 11.4 9.0–14.4ROR 11.4 · calibrated p 0.022 ✓ | 10.6 EB05 8.6 · IC025 +3.0 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 6.1 (4.5–8.2) | Not in label — unassessed | serious n=73 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Renal neoplasm | 105 | 10.3 8.5–12.6ROR 10.4 · calibrated p 0.030 ✓ | 9.7 EB05 8.2 · IC025 +2.9 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 12.7 (9.5–17.0) | Not in label — unassessed | serious n=104 · 100% consumer | NCT00097786: 1/2,297 (0.0%) on Valsartan; 1/2,283 (0.0%) control (serious AE) |
| Proctitis | 138 | 10.3 8.7–12.3ROR 10.4 · calibrated p 0.030 ✓ | 9.7 EB05 8.4 · IC025 +3.0 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 10.2 (8.0–12.9) | Not in label — unassessed | serious n=138 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Infarction | 332 | 10.1 9.0–11.3ROR 10.1 · calibrated p 0.031 ✓ | 9.6 EB05 8.7 · IC025 +3.1 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 12.7 (10.8–15.0) | Labeled — boxed warning exact term | serious PRR 7.3 · 88% consumer | NCT00097786: 23/2,305 (1.0%) on Valsartan; 32/2,283 (1.4%) control (serious AE) |
| Rebound acid hypersecretion | 135 | 9.2 7.7–10.9ROR 9.2 · calibrated p 0.044 ✓ | 8.7 EB05 7.5 · IC025 +2.8 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 12.7 (9.8–16.4) | Not in label — unassessed | serious n=135 | not reported in cached trials |
| Hypertensive heart disease | 82 | 9.1 7.3–11.4ROR 9.1 · calibrated p 0.047 ✓ | 8.5 EB05 7.0 · IC025 +2.7 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 8.8 (6.5–11.9) | Likely indication confounding term in indications | serious n=79 · 100% clinician | NCT00097786: 1/2,305 (0.0%) on Valsartan; 2/2,283 (0.1%) control (serious AE) |
| Bundle branch block left | 178 | 8.7 7.5–10.1ROR 8.7 · calibrated p 0.052 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 4.4 (3.7–5.3) | Not in label — unassessed | serious n=178 | NCT00097786: 1/2,305 (0.0%) control (serious AE) |
| Cardiac failure chronic | 176 | 8.6 7.4–10.0ROR 8.6 · calibrated p 0.054 | 8.2 EB05 7.2 · IC025 +2.8 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 2.1 (1.8–2.4) | Not in label — unassessed | serious n=175 · ♀ 38% (drug 59%) · 100% clinician | NCT00097786: 16/2,305 (0.7%) on Valsartan; 26/2,283 (1.1%) control (serious AE) |
| Aortic valve stenosis | 74 | 8.6 6.8–10.9ROR 8.6 · calibrated p 0.056 | 8.0 EB05 6.6 · IC025 +2.6 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 7.4 (5.5–10.0) | Not in label — unassessed | serious n=74 · ♀ 100% (drug 59%) · 100% clinician | NCT00097786: 3/2,305 (0.1%) on Valsartan; 2/2,283 (0.1%) control (serious AE) |
| Diverticulum intestinal | 180 | 8.6 7.4–10.0ROR 8.6 · calibrated p 0.054 | 8.2 EB05 7.2 · IC025 +2.8 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 9.1 (7.4–11.2) | Not in label — unassessed | serious n=179 | NCT00097786: 3/2,305 (0.1%) on Valsartan; 3/2,283 (0.1%) control (serious AE) |
| Anxiety disorder | 138 | 8.6 7.2–10.1ROR 8.6 · calibrated p 0.055 | 8.1 EB05 7.0 · IC025 +2.7 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 11.1 (8.7–14.2) | Not in label — unassessed | serious n=135 | NCT00097786: 1/2,297 (0.0%) on Valsartan (serious AE) |
| Diastolic dysfunction | 125 | 8.4 7.0–10.0ROR 8.4 · calibrated p 0.059 | 7.9 EB05 6.8 · IC025 +2.7 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 5.9 (4.7–7.4) | Likely indication confounding term in indications | serious n=122 | NCT00097786: 1/2,283 (0.0%) control (serious AE) |
| Aortic arteriosclerosis | 103 | 8.3 6.8–10.1ROR 8.3 · calibrated p 0.061 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 9.5 (7.2–12.4) | Not in label — unassessed | serious n=103 · 100% clinician | NCT00097786: 1/2,283 (0.0%) control (serious AE) |
| Left ventricular hypertrophy | 169 | 8.2 7.0–9.6ROR 8.2 · calibrated p 0.063 | 7.8 EB05 6.8 · IC025 +2.7 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 5.8 (4.8–7.0) | Likely indication confounding shares a disease stem with the indications wording | serious n=168 | NCT00097786: 3/2,297 (0.1%) on Valsartan; 1/2,305 (0.0%) control (serious AE) |
| Major depression | 288 | 8.2 7.3–9.2ROR 8.2 · calibrated p 0.063 | 7.8 EB05 7.1 · IC025 +2.8 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 10.4 (8.8–12.3) | Not in label — unassessed | serious PRR 6.2 | NCT00097786: 1/2,305 (0.0%) on Valsartan; 4/2,283 (0.2%) control (serious AE) |
| End stage renal disease | 706 | 8.0 7.4–8.6ROR 8.0 · calibrated p 0.067 | 7.7 EB05 7.2 · IC025 +2.8 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 13.2 (11.8–14.7) | Not in label — unassessed | serious PRR 5.8 | not reported in cached trials |
| Hyperuricaemia | 153 | 7.7 6.6–9.1ROR 7.7 · calibrated p 0.075 | 7.4 EB05 6.4 · IC025 +2.6 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 9.4 (7.5–11.8) | Not in label — unassessed | serious n=150 | NCT00097786: 1/2,305 (0.0%) control (serious AE) |
| Tricuspid valve incompetence | 287 | 7.5 6.7–8.5ROR 7.5 · calibrated p 0.080 | 7.2 EB05 6.5 · IC025 +2.7 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 5.7 (5.0–6.6) | Not in label — unassessed | serious PRR 5.5 | NCT00097786: 2/2,297 (0.1%) on Valsartan; 1/2,316 (0.0%) control (serious AE) |
| Hypertensive crisis | 402 | 7.5 6.8–8.2ROR 7.5 · calibrated p 0.082 | 7.2 EB05 6.6 · IC025 +2.7 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 8.2 (7.2–9.4) | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.4 | NCT00097786: 13/2,305 (0.6%) on Valsartan; 13/2,283 (0.6%) control (serious AE) |
| Blood pressure diastolic decreased | 266 | 7.4 6.6–8.4ROR 7.4 · calibrated p 0.084 | 7.1 EB05 6.4 · IC025 +2.6 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 5.3 (4.6–6.2) | Likely indication confounding term in indications | serious PRR 5.6 | not reported in cached trials |
| Mitral valve incompetence | 404 | 7.4 6.7–8.2ROR 7.4 · calibrated p 0.084 | 7.1 EB05 6.5 · IC025 +2.7 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 4.8 (4.3–5.5) | Not in label — unassessed | age-adj. PRR 6.0 · serious PRR 5.4 | NCT00097786: 2/2,305 (0.1%) on Valsartan; 4/2,283 (0.2%) control (serious AE) |
| Tachyarrhythmia | 88 | 7.3 5.9–9.0ROR 7.3 · calibrated p 0.091 | 6.8 EB05 5.7 · IC025 +2.4 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 6.8 (5.1–8.9) | Not in label — unassessed | serious n=88 · ♀ 100% (drug 59%) · 100% clinician | NCT00097786: 1/2,297 (0.0%) on Valsartan; 1/2,305 (0.0%) control (serious AE) |
| Renal cyst | 275 | 7.1 6.3–8.1ROR 7.2 · calibrated p 0.093 | 6.9 EB05 6.2 · IC025 +2.6 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 7.6 (6.5–8.9) | Not in label — unassessed | serious PRR 5.5 | NCT00097786: 1/2,283 (0.0%) control (serious AE) |
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 |
|---|---|---|---|
| Hyponatraemia | 1,608 | 4.13.9–4.3 | signal |
| Heart failure | 3,285 | 3.73.6–3.9 | signal |
| Kidney injury | 8,050 | 3.63.5–3.7 | signal |
| Arrhythmia / qt | 2,906 | 3.02.9–3.2 | signal |
| Stroke | 3,228 | 2.62.5–2.7 | signal |
| Myocardial infarction | 2,604 | 2.62.5–2.7 | signal |
| Hyperglycaemia / diabetes | 4,345 | 2.52.5–2.6 | signal |
| Rhabdomyolysis / myopathy | 996 | 2.52.3–2.6 | signal |
| Gi bleeding | 2,171 | 2.42.3–2.5 | signal |
| Anaemia | 3,542 | 2.42.3–2.5 | signal |
| Hypoglycaemia | 1,016 | 2.12.0–2.3 | signal |
| Fall / fracture | 3,980 | 2.12.0–2.2 | signal |
| Interstitial lung disease | 973 | 2.01.9–2.2 | raised |
| Tendon disorder | 354 | 1.91.7–2.1 | raised |
| Pancreatitis | 698 | 1.71.6–1.9 | raised |
| Depression | 2,261 | 1.61.6–1.7 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Valsartan 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 (26 of 40 signal terms matched).
- NCT00097786 — Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Comp (N=9306, PHASE3; 1704 AE terms posted; arms: Valsartan 160 mg od + Nateglinide 60 mg ; Valsartan 160 mg od + Placebo Nateglinid; Nateglinide 60 mg ac + Placebo Valsartan; 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 6,355 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.285 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Angiotensin 2 Receptor Blockers: PRR 6.2 (6.0–6.4) | Reporting / coding artifact | age-adj. PRR 1.1 · serious PRR 1.3 | not reported in cached trials |
| Fatigue (tiredness) | 5,635 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.632 | 1.5 EB05 1.4 · IC025 +0.5 vs other Angiotensin 2 Receptor Blockers: PRR 3.4 (3.4–3.5) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.5 | NCT00097786: 1/2,305 (0.0%) control (serious AE) |
| Dizziness | 5,369 | 2.2 2.1–2.2ROR 2.2 · calibrated p 0.931 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 3.6 (3.5–3.7) | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 2.1 | NCT00097786: 13/2,305 (0.6%) on Valsartan; 10/2,283 (0.4%) control (serious AE) |
| Dyspnoea (shortness of breath) | 5,366 | 1.9 1.9–2.0ROR 2.0 · calibrated p 0.923 | 1.9 EB05 1.9 · IC025 +0.9 vs other Angiotensin 2 Receptor Blockers: PRR 3.4 (3.3–3.5) | Not in label — unassessed | age-adj. PRR 1.7 · serious PRR 1.7 | NCT00097786: 28/2,305 (1.2%) on Valsartan; 15/2,283 (0.7%) control (serious AE) |
| Nausea | 5,254 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.546 | 1.3 EB05 1.3 · IC025 +0.4 vs other Angiotensin 2 Receptor Blockers: PRR 5.8 (5.7–6.0) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.4 | NCT00097786: 9/2,305 (0.4%) on Valsartan; 10/2,283 (0.4%) control (serious AE) |
| Diarrhoea (diarrhea) | 4,709 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.638 | 1.5 EB05 1.4 · IC025 +0.5 vs other Angiotensin 2 Receptor Blockers: PRR 5.2 (5.0–5.3) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.4 | NCT00097786: 9/2,305 (0.4%) on Valsartan; 7/2,283 (0.3%) control (serious AE) |
| Headache | 4,612 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.644 | 1.5 EB05 1.4 · IC025 +0.5 vs other Angiotensin 2 Receptor Blockers: PRR 6.1 (5.9–6.3) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.6 | NCT00097786: 1/2,305 (0.0%) control (serious AE) |
| Hypertension (high blood pressure) | 4,352 | 4.2 4.1–4.3ROR 4.3 · calibrated p 0.323 | 4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 6.2 (6.0–6.5) | Labeled — boxed warning exact term | age-adj. PRR 3.4 · serious PRR 3.5 | NCT00097786: 4/2,305 (0.2%) on Valsartan; 2/2,283 (0.1%) control (serious AE) |
| Blood pressure increased | 4,275 | 5.7 5.6–5.9ROR 5.9 · calibrated p 0.154 | 5.6 EB05 5.5 · IC025 +2.4 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 7.3 (7.0–7.5) | Labeled — boxed warning synonym match | age-adj. PRR 4.2 · serious PRR 5.1 | NCT00097786: 2/2,305 (0.1%) control (serious AE) |
| Pain | 3,875 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.491 | 1.3 EB05 1.2 · IC025 +0.3 vs other Angiotensin 2 Receptor Blockers: PRR 6.2 (5.9–6.4) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.2 | NCT00097786: 15/2,305 (0.7%) on Valsartan; 13/2,283 (0.6%) control (serious AE) |
| Fall | 3,658 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.919 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 4.6 (4.4–4.8) | Not in label — unassessed | age-adj. PRR 1.5 · serious PRR 1.9 | NCT00097786: 59/2,305 (2.6%) on Valsartan; 47/2,283 (2.1%) control (serious AE) |
| Asthenia (weakness) | 3,654 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.941 | 1.9 EB05 1.9 · IC025 +0.9 vs other Angiotensin 2 Receptor Blockers: PRR 4.1 (4.0–4.3) | Not in label — unassessed | age-adj. PRR 1.5 · serious PRR 1.7 | NCT00097786: 6/2,305 (0.3%) on Valsartan; 6/2,283 (0.3%) control (serious AE) |
| Malaise (feeling unwell) | 3,635 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.762 | 1.7 EB05 1.6 · IC025 +0.7 vs other Angiotensin 2 Receptor Blockers: PRR 4.0 (3.8–4.1) | Not in label — unassessed | age-adj. PRR 1.5 · serious PRR 1.7 | NCT00097786: 2/2,297 (0.1%) on Valsartan; 1/2,316 (0.0%) control (serious AE) |
| Acute kidney injury (sudden kidney damage) | 3,260 | 4.4 4.2–4.5ROR 4.5 · calibrated p 0.300 | 4.3 EB05 4.2 · IC025 +2.0 3/3 methods agree vs other Angiotensin 2 Receptor Blockers: PRR 4.6 (4.4–4.8) | Labeled — boxed warning synonym match | age-adj. PRR 2.9 · serious PRR 3.2 | not reported in cached trials |
| Off label use (used outside approved label) | 3,060 | 0.7 0.7–0.7ROR 0.7 · calibrated p 0.129 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC vs other Angiotensin 2 Receptor Blockers: PRR 4.4 (4.3–4.6) | Reporting / coding artifact | age-adj. PRR 0.8 · serious PRR 0.8 | 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=124, PRR 137.3
- Physical deconditioning — n=272, PRR 24.4
- Nephrogenic anaemia — n=433, PRR 20.4
- Hyperparathyroidism secondary — n=215, PRR 18.5 (also seen in trial arm)
- Fear of disease — n=144, PRR 17.4
- Female genital tract fistula — n=136, PRR 17.1 (also seen in trial arm)
- Chronic kidney disease-mineral and bone disorder — n=84, PRR 16.9
- Macular degeneration — n=910, PRR 16.5 (also seen in trial arm)
- Multi-organ disorder — n=144, PRR 15.6 (also seen in trial arm)
- Osteochondrosis — n=80, PRR 14.7 (also seen in trial arm)
✓ A hand-written Bradford Hill causality assessment exists for this drug: Valsartan ↔ Acute kidney injury.
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 Valsartan?
In FDA FAERS, the most frequently co-reported reaction terms for Valsartan are fatigue, dizziness, dyspnoea, nausea, diarrhoea, headache. 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 Valsartan have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue valsartan tablets as soon as possible. (5.1) • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
Do FAERS signals prove that Valsartan 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 0878f27e-5368-c93f-e063-6394a90a1086, effective 20250109; matched on
openfda.generic_name.exact:"VALSARTAN" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 60846 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, 1,195 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
VALSARTAN, 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.