Valsartan and Hydrochlorothiazide side effects: what 13,500 FDA adverse event reports show
Drug class
Angiotensin 2 Receptor Blocker
Label matched
Valsartan (Valsartan)
Who reports
13,500 reports · 77% serious · 1,383 with death outcome · 66% female
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.
What it is
Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as L-valine, N -(1-oxopentyl)- N -[[2′-(1 H -tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-.
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.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled (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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,049 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Bronchial neoplasm | 16 | 206.0 122.3–347.0ROR 206.2 · χ² 2,699 / p <1e-300 | 149.6 EB05 97.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=16 | NCT00097786: 1/2,283 (0.0%) control (serious AE) |
| Bronchial haemorrhage | 16 | 83.1 50.3–137.4ROR 83.2 · χ² 1,154 / p 3e-253 | 72.3 EB05 47.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Nasal turbinate hypertrophy | 17 | 73.6 45.2–119.6ROR 73.7 · χ² 1,093 / p 6e-240 | 65.3 EB05 43.2 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | NCT00097786: 1/2,316 (0.0%) control (serious AE) |
| Endometrial ablation | 16 | 73.4 44.5–121.2ROR 73.5 · χ² 1,022 / p 1e-224 | 64.9 EB05 42.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Blood pressure inadequately controlled | 229 | 60.9 53.5–69.5ROR 62.0 · χ² 12,932 / p <1e-300 | 58.4 EB05 52.3 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious n=213 | not reported in cached trials |
| Venous occlusion | 34 | 29.4 20.9–41.3ROR 29.5 · χ² 887 / p 3e-195 | 28.5 EB05 21.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=34 · 87% consumer | NCT00097786: 1/2,305 (0.0%) control (serious AE) |
| Microalbuminuria | 14 | 29.1 17.2–49.4ROR 29.1 · χ² 346 / p 2e-77 | 27.6 EB05 17.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Dementia alzheimer's type | 29 | 27.0 18.7–39.0ROR 27.1 · χ² 689 / p 4e-152 | 26.2 EB05 19.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=29 · 80% consumer | NCT00097786: 2/2,305 (0.1%) control (serious AE) |
| Senile dementia | 11 | 26.3 14.5–47.7ROR 26.3 · χ² 239 / p 4e-54 | 24.7 EB05 14.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=11 | NCT00097786: 1/2,297 (0.0%) on Valsartan and Hydrochlorothiazide (serious AE) |
| Infarction | 107 | 24.4 20.2–29.5ROR 24.6 · χ² 2,344 / p <1e-300 | 24.0 EB05 20.4 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 18.0 · 87% consumer | NCT00097786: 23/2,305 (1.0%) on Valsartan and Hydrochlorothiazide; 32/2,283 (1.4%) control (serious AE) |
| Bronchial disorder | 19 | 19.1 12.2–30.1ROR 19.2 · χ² 305 / p 1e-68 | 18.5 EB05 12.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=19 | NCT00097786: 1/2,316 (0.0%) on Valsartan and Hydrochlorothiazide; 2/2,305 (0.1%) control (serious AE) |
| Labyrinthitis | 30 | 18.5 12.9–26.5ROR 18.5 · χ² 473 / p 4e-105 | 18.0 EB05 13.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=30 · 79% consumer | NCT00097786: 1/2,305 (0.0%) on Valsartan and Hydrochlorothiazide; 1/2,283 (0.0%) control (serious AE) |
| Rhonchi | 16 | 18.1 11.1–29.7ROR 18.1 · χ² 239 / p 3e-54 | 17.3 EB05 10.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Angioplasty | 15 | 15.7 9.5–26.1ROR 15.7 · χ² 190 / p 1e-43 | 14.7 EB05 8.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Product blister packaging issue | 10 | 15.2 8.2–28.4ROR 15.3 · χ² 118 / p 8e-28 | 13.4 EB05 6.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=8 | not reported in cached trials |
| Blood pressure fluctuation | 197 | 12.8 11.1–14.7ROR 13.0 · χ² 2,118 / p <1e-300 | 12.7 EB05 11.2 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 10.9 · 74% consumer | not reported in cached trials |
| Blood urea decreased | 10 | 12.5 6.7–23.3ROR 12.5 · χ² 94 / p 2e-22 | 10.4 EB05 5.3 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious n=10 | not reported in cached trials |
| Hypertensive heart disease | 14 | 11.6 6.9–19.7ROR 11.6 · χ² 125 / p 3e-29 | 10.1 EB05 5.9 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious n=14 | NCT00097786: 1/2,305 (0.0%) on Valsartan and Hydrochlorothiazide; 2/2,283 (0.1%) control (serious AE) |
| Catheterisation cardiac | 32 | 11.3 8.0–15.9ROR 11.3 · χ² 287 / p 1e-64 | 10.6 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Diabetic complication | 16 | 9.7 6.0–15.9ROR 9.8 · χ² 116 / p 2e-27 | 8.4 EB05 5.2 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=15 | not reported in cached trials |
| Cardiac pacemaker insertion | 37 | 9.7 7.0–13.4ROR 9.7 · χ² 278 / p 1e-62 | 9.1 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=37 · 86% consumer | not reported in cached trials |
| Urine output increased | 16 | 9.5 5.8–15.6ROR 9.5 · χ² 113 / p 1e-26 | 8.2 EB05 5.1 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious n=16 | not reported in cached trials |
| Thyroid neoplasm | 17 | 9.5 5.9–15.3ROR 9.5 · χ² 120 / p 3e-28 | 8.2 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=17 | NCT00097786: 1/2,297 (0.0%) on Valsartan and Hydrochlorothiazide; 2/2,283 (0.1%) control (serious AE) |
| Spinal cord disorder | 10 | 9.5 5.1–17.6ROR 9.5 · χ² 67 / p 1e-16 | 7.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=10 | NCT00097786: 2/2,305 (0.1%) on Valsartan and Hydrochlorothiazide; 1/2,283 (0.0%) control (serious AE) |
| Colonic polyp | 10 | 9.3 5.0–17.3ROR 9.3 · χ² 66 / p 3e-16 | 7.3 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=10 | NCT00097786: 1/2,305 (0.0%) on Valsartan and Hydrochlorothiazide; 7/2,283 (0.3%) control (serious AE) |
| Pancreatic carcinoma metastatic | 17 | 9.3 5.8–15.0ROR 9.3 · χ² 117 / p 1e-27 | 8.0 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=17 | NCT00097786: 1/2,297 (0.0%) on Valsartan and Hydrochlorothiazide; 4/2,283 (0.2%) control (serious AE) |
| Facial palsy | 13 | 9.3 5.4–16.0ROR 9.3 · χ² 87 / p 5e-21 | 7.6 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=13 | NCT00097786: 1/2,305 (0.0%) on Valsartan and Hydrochlorothiazide; 1/2,283 (0.0%) control (serious AE) |
| Essential hypertension | 15 | 9.0 5.4–15.0ROR 9.1 · χ² 99 / p 1e-23 | 7.6 EB05 4.7 · IC025 +2.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=7 | NCT00097786: 2/2,305 (0.1%) on Valsartan and Hydrochlorothiazide; 2/2,283 (0.1%) control (serious AE) |
| Nephrogenic anaemia | 27 | 9.0 6.2–13.2ROR 9.0 · χ² 183 / p 4e-42 | 8.2 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=27 | not reported in cached trials |
| Blood uric acid increased | 33 | 8.9 6.3–12.6ROR 9.0 · χ² 223 / p 8e-51 | 8.2 EB05 6.0 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious n=28 | not reported in cached trials |
| Dengue fever | 13 | 8.8 5.1–15.2ROR 8.8 · χ² 82 / p 7e-20 | 7.2 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=13 | NCT00097786: 2/2,297 (0.1%) on Valsartan and Hydrochlorothiazide (serious AE) |
| Hyperparathyroidism secondary | 14 | 8.6 5.1–14.6ROR 8.6 · χ² 86 / p 7e-21 | 7.2 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=14 | NCT00097786: 1/2,297 (0.0%) on Valsartan and Hydrochlorothiazide; 1/2,283 (0.0%) control (serious AE) |
| Breath sounds abnormal | 27 | 8.5 5.9–12.5ROR 8.6 · χ² 171 / p 2e-39 | 7.7 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=27 | not reported in cached trials |
| Blood chloride decreased | 14 | 8.4 5.0–14.2ROR 8.4 · χ² 84 / p 3e-20 | 7.0 EB05 4.3 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious n=14 | not reported in cached trials |
| Blood pressure increased | 822 | 8.4 7.8–8.9ROR 8.9 · χ² 5,340 / p <1e-300 | 8.3 EB05 7.8 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.1 · 71% consumer | NCT00097786: 2/2,305 (0.1%) control (serious AE) |
| Cardiomegaly | 65 | 8.2 6.4–10.4ROR 8.2 · χ² 400 / p 2e-89 | 7.8 EB05 6.3 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.1 | NCT00097786: 1/2,297 (0.0%) on Valsartan and Hydrochlorothiazide; 2/2,305 (0.1%) control (serious AE) |
| Arterial disorder | 10 | 8.2 4.4–15.2ROR 8.2 · χ² 56 / p 5e-14 | 6.3 EB05 3.6 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=10 | NCT00097786: 1/2,305 (0.0%) control (serious AE) |
| Diabetic neuropathy | 26 | 8.1 5.5–12.0ROR 8.2 · χ² 155 / p 6e-36 | 7.3 EB05 5.2 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=26 | NCT00097786: 1/2,297 (0.0%) on Valsartan and Hydrochlorothiazide (serious AE) |
| Apparent death | 19 | 8.1 5.2–12.7ROR 8.1 · χ² 111 / p 3e-26 | 7.0 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Ischaemia | 24 | 8.1 5.4–12.1ROR 8.1 · χ² 142 / p 6e-33 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=24 · 74% consumer | NCT00097786: 22/2,305 (1.0%) on Valsartan and Hydrochlorothiazide; 17/2,283 (0.7%) control (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Valsartan and Hydrochlorothiazide 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 (22 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 |
|---|---|---|---|---|---|---|
| Blood pressure increased | 822 | 8.4 7.8–8.9ROR 8.9 · χ² 5,340 / p <1e-300 | 8.3 EB05 7.8 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.1 · 71% consumer | NCT00097786: 2/2,305 (0.1%) control (serious AE) |
| Dizziness | 801 | 2.5 2.3–2.7ROR 2.6 · χ² 737 / p 1e-162 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | NCT00097786: 13/2,305 (0.6%) on Valsartan and Hydrochlorothiazide; 10/2,283 (0.4%) control (serious AE) |
| Hypertension (high blood pressure) | 775 | 5.7 5.3–6.1ROR 6.0 · χ² 3,015 / p <1e-300 | 5.7 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.9 | NCT00097786: 4/2,305 (0.2%) on Valsartan and Hydrochlorothiazide; 2/2,283 (0.1%) control (serious AE) |
| Drug ineffective (drug did not work) | 746 | 0.9 0.8–0.9ROR 0.9 · χ² 13 / p 2e-4 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.1 | not reported in cached trials |
| Headache | 711 | 1.8 1.6–1.9ROR 1.8 · χ² 242 / p 8e-55 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.0 | NCT00097786: 1/2,305 (0.0%) control (serious AE) |
| Fatigue (tiredness) | 691 | 1.4 1.3–1.5ROR 1.4 · χ² 75 / p 2e-18 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT00097786: 1/2,305 (0.0%) control (serious AE) |
| Nausea | 656 | 1.3 1.2–1.4ROR 1.3 · χ² 45 / p 1e-11 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT00097786: 9/2,305 (0.4%) on Valsartan and Hydrochlorothiazide; 10/2,283 (0.4%) control (serious AE) |
| Dyspnoea (shortness of breath) | 612 | 1.7 1.6–1.8ROR 1.7 · χ² 173 / p 9e-40 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.5 | NCT00097786: 28/2,305 (1.2%) on Valsartan and Hydrochlorothiazide; 15/2,283 (0.7%) control (serious AE) |
| Malaise (feeling unwell) | 568 | 2.0 1.9–2.2ROR 2.1 · χ² 292 / p 7e-66 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.1 | NCT00097786: 2/2,297 (0.1%) on Valsartan and Hydrochlorothiazide; 1/2,316 (0.0%) control (serious AE) |
| Fall | 558 | 2.6 2.4–2.8ROR 2.7 · χ² 560 / p 3e-124 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | NCT00097786: 59/2,305 (2.6%) on Valsartan and Hydrochlorothiazide; 47/2,283 (2.1%) control (serious AE) |
| Pain | 531 | 1.3 1.2–1.5ROR 1.4 · χ² 47 / p 4e-12 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT00097786: 15/2,305 (0.7%) on Valsartan and Hydrochlorothiazide; 13/2,283 (0.6%) control (serious AE) |
| Death | 496 | 0.9 0.8–1.0ROR 0.9 · χ² 6 / p 0.006 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.7 · 74% consumer | NCT00097786: 1/2,297 (0.0%) on Valsartan and Hydrochlorothiazide (serious AE) |
| Diarrhoea (diarrhea) | 465 | 1.1 1.0–1.2ROR 1.1 · χ² 6 / p 0.006 | 1.1 EB05 1.0 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 1.0 | NCT00097786: 9/2,305 (0.4%) on Valsartan and Hydrochlorothiazide; 7/2,283 (0.3%) control (serious AE) |
| Cerebrovascular accident (stroke) | 445 | 4.1 3.7–4.5ROR 4.2 · χ² 1,034 / p 3e-227 | 4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | NCT00097786: 28/2,305 (1.2%) on Valsartan and Hydrochlorothiazide; 34/2,283 (1.5%) control (serious AE) |
| Asthenia (weakness) | 429 | 1.8 1.6–1.9ROR 1.8 · χ² 146 / p 6e-34 | 1.8 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.5 | NCT00097786: 6/2,305 (0.3%) on Valsartan and Hydrochlorothiazide; 6/2,283 (0.3%) control (serious AE) |
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.
- Venous occlusion — n=34, PRR 29.4 (also seen in trial arm)
- Dementia alzheimer's type — n=29, PRR 27.0 (also seen in trial arm)
- Labyrinthitis — n=30, PRR 18.5 (also seen in trial arm)
- Catheterisation cardiac — n=32, PRR 11.3
- Cardiac pacemaker insertion — n=37, PRR 9.7
- Nephrogenic anaemia — n=27, PRR 9.0
- Breath sounds abnormal — n=27, PRR 8.5
- Ischaemia — n=24, PRR 8.1 (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 and Hydrochlorothiazide?
In FDA FAERS, the most frequently co-reported reaction terms for Valsartan and Hydrochlorothiazide are blood pressure increased, dizziness, hypertension, headache, fatigue, nausea. 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 and Hydrochlorothiazide 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 and Hydrochlorothiazide 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") - 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, 1,089 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 2026-10-08. 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.