Amlodipine Valsartan side effects: what 3,649 FDA adverse event reports show
Drug class
Thiazide Diuretic, Angiotensin 2 Receptor Blocker
Label matched
Amlodipine Valsartan And Hydrochlorothiazide (Exforge Hct)
Who reports
3,649 reports · 93% serious · 501 with death outcome · 58% female
Used for
Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) is indicated for 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.
What it is
Exforge HCT is a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Exforge HCT contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol.
Boxed warning
FETAL TOXICITY When pregnancy is detected, discontinue Exforge HCT 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 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 175 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 |
|---|---|---|---|---|---|---|
| Hypertensive crisis | 44 | 22.7 16.9–30.5ROR 23.0 · χ² 889 / p 9e-196 | 22.5 EB05 17.4 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 14.1 · 70% consumer | no trial data cached |
| Deafness | 99 | 21.8 17.9–26.5ROR 22.4 · χ² 1,939 / p <1e-300 | 21.6 EB05 18.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 · 83% consumer | no trial data cached |
| Blood pressure abnormal | 59 | 17.2 13.3–22.1ROR 17.4 · χ² 880 / p 1e-193 | 17.0 EB05 13.6 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.2 · 81% consumer | no trial data cached |
| Product prescribing error | 65 | 15.8 12.4–20.1ROR 16.1 · χ² 886 / p 6e-195 | 15.7 EB05 12.7 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 20.4 · 71% consumer | no trial data cached |
| Blood pressure fluctuation | 63 | 15.1 11.8–19.3ROR 15.3 · χ² 813 / p 4e-179 | 14.9 EB05 12.0 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 11.0 · 77% consumer | no trial data cached |
| Cardiomegaly | 32 | 14.9 10.5–21.0ROR 15.0 · χ² 399 / p 4e-89 | 14.5 EB05 10.6 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.1 · 84% consumer | no trial data cached |
| Blood pressure decreased | 170 | 14.8 12.7–17.1ROR 15.4 · χ² 2,169 / p <1e-300 | 14.7 EB05 12.9 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 11.3 · 76% consumer | no trial data cached |
| Blood pressure increased | 378 | 14.2 12.9–15.6ROR 15.7 · χ² 4,651 / p <1e-300 | 14.2 EB05 13.0 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 12.3 · 80% consumer | no trial data cached |
| Diabetes mellitus | 187 | 14.1 12.2–16.2ROR 14.8 · χ² 2,259 / p <1e-300 | 14.0 EB05 12.4 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.4 · 84% consumer | no trial data cached |
| Spinal disorder | 18 | 10.9 6.9–17.3ROR 11.0 · χ² 152 / p 3e-35 | 9.8 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Accident | 21 | 10.2 6.6–15.6ROR 10.2 · χ² 164 / p 8e-38 | 9.2 EB05 6.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · 81% consumer | no trial data cached |
| Blood sodium decreased | 33 | 10.1 7.2–14.2ROR 10.2 · χ² 261 / p 5e-59 | 9.5 EB05 6.9 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.1 | no trial data cached |
| Arrhythmia | 73 | 8.8 7.0–11.1ROR 9.0 · χ² 500 / p 6e-111 | 8.5 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 78% consumer | no trial data cached |
| Drug prescribing error | 29 | 8.6 6.0–12.3ROR 8.6 · χ² 186 / p 1e-42 | 7.8 EB05 5.6 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious n=27 · 76% consumer | no trial data cached |
| Blood triglycerides increased | 26 | 8.4 5.8–12.4ROR 8.5 · χ² 163 / p 1e-37 | 7.6 EB05 5.4 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 · 72% consumer | no trial data cached |
| Blood pressure systolic increased | 28 | 8.2 5.7–11.9ROR 8.3 · χ² 170 / p 3e-39 | 7.5 EB05 5.3 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.4 · 79% consumer | no trial data cached |
| Wrong technique in drug usage process | 50 | 7.8 5.9–10.3ROR 7.9 · χ² 290 / p 2e-65 | 7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 14.1 · 90% consumer | no trial data cached |
| Hiatus hernia | 17 | 7.5 4.7–12.1ROR 7.6 · χ² 90 / p 1e-21 | 6.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Retinal detachment | 11 | 6.9 3.8–12.4ROR 6.9 · χ² 50 / p 1e-12 | 5.5 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Arteriosclerosis | 11 | 6.7 3.7–12.1ROR 6.7 · χ² 48 / p 2e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Blindness | 46 | 6.5 4.9–8.7ROR 6.6 · χ² 209 / p 1e-47 | 6.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 84% consumer | no trial data cached |
| Cataract | 67 | 6.5 5.1–8.2ROR 6.6 · χ² 307 / p 6e-69 | 6.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 83% consumer | no trial data cached |
| Eye haemorrhage | 15 | 6.5 3.9–10.7ROR 6.5 · χ² 64 / p 7e-16 | 5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Wrong technique in product usage process | 226 | 6.4 5.7–7.3ROR 6.8 · χ² 1,041 / p 1e-228 | 6.4 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 23.0 · 84% consumer | no trial data cached |
| Cerebral infarction | 27 | 6.3 4.4–9.2ROR 6.4 · χ² 116 / p 2e-27 | 5.8 EB05 4.2 · IC025 +1.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.9 · 85% consumer | no trial data cached |
| Hypertension (high blood pressure) | 230 | 6.2 5.5–7.1ROR 6.6 · χ² 1,016 / p 3e-223 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.8 · 74% consumer | no trial data cached |
| Eating disorder | 23 | 6.2 4.1–9.3ROR 6.2 · χ² 95 / p 1e-22 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 91% consumer | no trial data cached |
| Kidney infection | 21 | 6.2 4.0–9.4ROR 6.2 · χ² 86 / p 1e-20 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 86% consumer | no trial data cached |
| Hypoacusis | 44 | 5.9 4.4–7.9ROR 6.0 · χ² 174 / p 5e-40 | 5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · 86% consumer | no trial data cached |
| Angina pectoris | 29 | 5.8 4.0–8.3ROR 5.8 · χ² 110 / p 5e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Glaucoma | 19 | 5.7 3.6–8.9ROR 5.7 · χ² 68 / p 6e-17 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.8 | no trial data cached |
| Fluid retention | 49 | 5.5 4.2–7.3ROR 5.6 · χ² 178 / p 6e-41 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 84% consumer | no trial data cached |
| Fear | 26 | 5.5 3.8–8.1ROR 5.5 · χ² 92 / p 5e-22 | 5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Gastritis | 25 | 5.5 3.7–8.1ROR 5.5 · χ² 87 / p 6e-21 | 5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · ♀ 84% (drug 58%) | no trial data cached |
| Visual impairment | 114 | 5.3 4.4–6.4ROR 5.5 · χ² 399 / p 6e-89 | 5.2 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · 79% consumer | no trial data cached |
| Thyroid disorder | 14 | 5.2 3.1–8.8ROR 5.2 · χ² 44 / p 2e-11 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Ankle fracture | 14 | 5.2 3.1–8.8ROR 5.2 · χ² 43 / p 2e-11 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Hypokinesia | 13 | 5.1 3.0–8.9ROR 5.2 · χ² 39 / p 2e-10 | 4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Renal disorder | 41 | 5.0 3.7–6.8ROR 5.1 · χ² 129 / p 3e-30 | 4.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · 85% consumer | no trial data cached |
| Glycosylated haemoglobin increased | 22 | 5.0 3.3–7.6ROR 5.0 · χ² 67 / p 1e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 7.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 378 | 14.2 12.9–15.6ROR 15.7 · χ² 4,651 / p <1e-300 | 14.2 EB05 13.0 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 12.3 · 80% consumer | no trial data cached |
| Death | 256 | 1.7 1.5–1.9ROR 1.8 · χ² 78 / p 6e-19 | 1.7 EB05 1.5 · IC025 +0.6 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 1.1 · 81% consumer | no trial data cached |
| Hypertension (high blood pressure) | 230 | 6.2 5.5–7.1ROR 6.6 · χ² 1,016 / p 3e-223 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.8 · 74% consumer | no trial data cached |
| Wrong technique in product usage process | 226 | 6.4 5.7–7.3ROR 6.8 · χ² 1,041 / p 1e-228 | 6.4 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 23.0 · 84% consumer | no trial data cached |
| Malaise (feeling unwell) | 207 | 2.7 2.4–3.1ROR 2.8 · χ² 226 / p 3e-51 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 76% consumer | no trial data cached |
| Diabetes mellitus | 187 | 14.1 12.2–16.2ROR 14.8 · χ² 2,259 / p <1e-300 | 14.0 EB05 12.4 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.4 · 84% consumer | no trial data cached |
| Blood pressure decreased | 170 | 14.8 12.7–17.1ROR 15.4 · χ² 2,169 / p <1e-300 | 14.7 EB05 12.9 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 11.3 · 76% consumer | no trial data cached |
| Feeling abnormal | 138 | 3.3 2.8–3.9ROR 3.4 · χ² 221 / p 3e-50 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 79% consumer | no trial data cached |
| Cerebrovascular accident (stroke) | 125 | 4.2 3.6–5.0ROR 4.3 · χ² 307 / p 5e-69 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 · 84% consumer | no trial data cached |
| Peripheral swelling | 125 | 4.7 3.9–5.6ROR 4.8 · χ² 361 / p 9e-81 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 72% consumer | no trial data cached |
| Hypotension (low blood pressure) | 117 | 3.4 2.8–4.0ROR 3.4 · χ² 193 / p 3e-44 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.3 | no trial data cached |
| Visual impairment | 114 | 5.3 4.4–6.4ROR 5.5 · χ² 399 / p 6e-89 | 5.2 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · 79% consumer | no trial data cached |
| Gait disturbance | 109 | 3.3 2.7–3.9ROR 3.3 · χ² 170 / p 3e-39 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 84% consumer | no trial data cached |
| Blood glucose increased | 99 | 3.0 2.5–3.7ROR 3.1 · χ² 132 / p 8e-31 | 3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 · 74% consumer | no trial data cached |
| Deafness | 99 | 21.8 17.9–26.5ROR 22.4 · χ² 1,939 / p <1e-300 | 21.6 EB05 18.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 · 83% consumer | no trial data cached |
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.
- Deafness — n=99, PRR 21.8
- Accident — n=21, PRR 10.2
- Arrhythmia — n=73, PRR 8.8
- Blindness — n=46, PRR 6.5
- Cataract — n=67, PRR 6.5
- Eating disorder — n=23, PRR 6.2
- Kidney infection — n=21, PRR 6.2
- Hypoacusis — n=44, PRR 5.9
- Angina pectoris — n=29, PRR 5.8
- Fluid retention — n=49, PRR 5.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Amlodipine (dihydropyridine CCBs) ↔ Peripheral oedema.
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 Amlodipine Valsartan?
In FDA FAERS, the most frequently co-reported reaction terms for Amlodipine Valsartan are blood pressure increased, hypertension, malaise, diabetes mellitus, blood pressure decreased, feeling abnormal. 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 Amlodipine Valsartan have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue Exforge HCT 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 Amlodipine 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 18d7820d-471f-4ee2-9ec6-25d8d27c77de, effective 20251212; matched on
openfda.generic_name.exact:"AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE") - 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, 215 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
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.