Drug · FAERS side-effect profile with label screen
Amlodipine and Valsartan side effects: what 11,004 FDA adverse event reports show
Drug class
Calcium channel blocker and may be
FDA label, Indications wording of the closest related product
Label matched
Amlodipine (Katerzia)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
11,004 reports · 86% serious · 1,268 with death outcome · 54% female
openFDA FAERS counts, all years, deduplication not applied
Used for
KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: Hypertension ( 1.1 ) KATERZIA is indicated for the treatment of hypertension in adults and children 6 years and older, to lower blood pressure.
FDA label, Indications and Usage
What it is
KATERZIA oral suspension contains 1.30 mg/mL amlodipine benzoate, equivalent to 1 mg/mL amlodipine, a long-acting calcium channel blocker. Amlodipine benzoate is chemically described as 3-Ethy.
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
Likely indication confounding 8Lab value / disease marker 2Not in label — unassessed 30
What the badges mean
- 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.
- 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. 1,030 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 |
|---|---|---|---|---|---|---|
| Papillary renal cell carcinoma | 12 | 183.4 101.4–331.6ROR 183.6 · χ² 1,820 / p <1e-300 | 132.5 EB05 80.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Blood pressure inadequately controlled | 159 | 51.3 43.9–60.0ROR 52.0 · χ² 7,586 / p <1e-300 | 49.7 EB05 43.5 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=149 · 71% consumer | no trial data cached |
| Protein-losing gastroenteropathy | 11 | 43.7 24.0–79.4ROR 43.8 · χ² 408 / p 5e-91 | 40.0 EB05 23.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Senile dementia | 13 | 38.2 22.1–66.2ROR 38.3 · χ² 426 / p 5e-95 | 35.7 EB05 22.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Infarction | 121 | 34.0 28.4–40.6ROR 34.3 · χ² 3,771 / p <1e-300 | 33.2 EB05 28.5 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 22.4 · 93% consumer | no trial data cached |
| Hypocoagulable state | 14 | 27.6 16.3–46.8ROR 27.6 · χ² 328 / p 1e-73 | 26.3 EB05 16.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Microalbuminuria | 10 | 25.4 13.6–47.3ROR 25.4 · χ² 207 / p 2e-47 | 23.8 EB05 13.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Peripheral sensorimotor neuropathy | 11 | 17.1 9.4–30.9ROR 17.1 · χ² 149 / p 1e-34 | 15.7 EB05 8.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Aortic valve stenosis | 12 | 12.9 7.3–22.7ROR 12.9 · χ² 119 / p 6e-28 | 11.2 EB05 6.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Hyperammonaemic encephalopathy | 11 | 12.3 6.8–22.3ROR 12.3 · χ² 103 / p 2e-24 | 10.4 EB05 5.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Nephrogenic anaemia | 30 | 12.3 8.6–17.6ROR 12.3 · χ² 298 / p 4e-67 | 11.7 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=30 | no trial data cached |
| Hyperparathyroidism secondary | 16 | 12.1 7.4–19.8ROR 12.1 · χ² 151 / p 5e-35 | 10.9 EB05 6.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Walking disability | 13 | 11.9 6.9–20.5ROR 11.9 · χ² 118 / p 8e-28 | 10.3 EB05 5.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Arterial occlusive disease | 48 | 11.6 8.8–15.5ROR 11.7 · χ² 454 / p 6e-101 | 11.3 EB05 8.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 91% consumer | no trial data cached |
| Linear iga disease | 10 | 11.5 6.2–21.4ROR 11.5 · χ² 85 / p 1e-20 | 9.4 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Lipoma | 15 | 11.1 6.7–18.4ROR 11.1 · χ² 127 / p 8e-30 | 9.7 EB05 5.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Maculopathy | 20 | 10.7 6.9–16.6ROR 10.7 · χ² 166 / p 3e-38 | 9.7 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 80% (drug 54%) · 85% consumer | no trial data cached |
| Aortic arteriosclerosis | 13 | 9.6 5.6–16.6ROR 9.7 · χ² 92 / p 5e-22 | 8.0 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Blood pressure abnormal | 97 | 9.4 7.7–11.4ROR 9.4 · χ² 714 / p 1e-157 | 9.1 EB05 7.7 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.2 · 87% consumer | no trial data cached |
| Dengue fever | 11 | 9.1 5.1–16.5ROR 9.1 · χ² 71 / p 1e-17 | 7.3 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Renal neoplasm | 10 | 9.0 4.8–16.7ROR 9.0 · χ² 63 / p 1e-15 | 7.0 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Diabetes mellitus | 352 | 8.8 7.9–9.7ROR 9.1 · χ² 2,422 / p <1e-300 | 8.7 EB05 8.0 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.2 · 78% consumer | no trial data cached |
| Blood pressure fluctuation | 109 | 8.7 7.2–10.4ROR 8.7 · χ² 729 / p 8e-161 | 8.4 EB05 7.2 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 6.6 · 79% consumer | no trial data cached |
| Diabetic nephropathy | 10 | 8.6 4.6–16.1ROR 8.6 · χ² 60 / p 5e-15 | 6.7 EB05 3.7 · IC025 +1.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Hypertensive crisis | 50 | 8.6 6.5–11.3ROR 8.6 · χ² 325 / p 5e-73 | 8.1 EB05 6.3 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.7 | no trial data cached |
| Gastrointestinal motility disorder | 23 | 8.3 5.5–12.5ROR 8.3 · χ² 140 / p 1e-32 | 7.4 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 100% (drug 54%) · 86% consumer | no trial data cached |
| Blood pressure increased | 660 | 8.2 7.7–8.9ROR 8.7 · χ² 4,204 / p <1e-300 | 8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.4 · 81% consumer | no trial data cached |
| Deafness | 111 | 8.1 6.7–9.8ROR 8.2 · χ² 682 / p 1e-150 | 7.9 EB05 6.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 84% consumer | no trial data cached |
| Erysipelas | 21 | 8.0 5.2–12.2ROR 8.0 · χ² 120 / p 3e-28 | 7.0 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Overweight | 22 | 7.8 5.2–11.9ROR 7.9 · χ² 124 / p 4e-29 | 6.9 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Asphyxia | 33 | 7.7 5.5–10.9ROR 7.7 · χ² 186 / p 1e-42 | 7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 84% consumer | no trial data cached |
| Hyperuricaemia | 16 | 7.5 4.6–12.2ROR 7.5 · χ² 83 / p 4e-20 | 6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Blood cholesterol abnormal | 17 | 7.0 4.4–11.3ROR 7.0 · χ² 82 / p 8e-20 | 6.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious n=16 | no trial data cached |
| Chondropathy | 10 | 7.0 3.8–13.0ROR 7.0 · χ² 45 / p 8e-12 | 5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Subdural haemorrhage | 10 | 6.9 3.7–12.9ROR 6.9 · χ² 45 / p 1e-11 | 5.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Tibia fracture | 17 | 6.9 4.3–11.1ROR 6.9 · χ² 80 / p 2e-19 | 5.9 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Cerebral haematoma | 12 | 6.8 3.9–12.0ROR 6.8 · χ² 54 / p 1e-13 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Venous thrombosis | 14 | 6.8 4.0–11.5ROR 6.8 · χ² 63 / p 9e-16 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Blood pressure diastolic decreased | 26 | 6.7 4.6–9.8ROR 6.7 · χ² 120 / p 3e-28 | 6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.5 | no trial data cached |
| Fibula fracture | 10 | 6.6 3.5–12.3ROR 6.6 · χ² 42 / p 5e-11 | 5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 | 660 | 8.2 7.7–8.9ROR 8.7 · χ² 4,204 / p <1e-300 | 8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.4 · 81% consumer | no trial data cached |
| Hypertension (high blood pressure) | 587 | 5.3 4.9–5.7ROR 5.5 · χ² 2,052 / p <1e-300 | 5.3 EB05 4.9 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.2 · 73% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 548 | 0.8 0.7–0.9ROR 0.8 · χ² 31 / p 1e-8 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 · 70% consumer | no trial data cached |
| Dizziness | 490 | 1.9 1.7–2.0ROR 1.9 · χ² 204 / p 1e-46 | 1.9 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Death | 469 | 1.0 0.9–1.1ROR 1.0 · χ² 1 / p 0.213 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.7 · 78% consumer | no trial data cached |
| Malaise (feeling unwell) | 469 | 2.0 1.9–2.2ROR 2.1 · χ² 251 / p 1e-56 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.0 · 72% consumer | no trial data cached |
| Fatigue (tiredness) | 443 | 1.1 1.0–1.2ROR 1.1 · χ² 3 / p 0.039 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Fall | 430 | 2.5 2.2–2.7ROR 2.5 · χ² 379 / p 1e-84 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Headache | 398 | 1.2 1.1–1.3ROR 1.2 · χ² 15 / p 6e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.3 · 72% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 364 | 1.2 1.1–1.4ROR 1.2 · χ² 15 / p 4e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 353 | 5.5 5.0–6.1ROR 5.7 · χ² 1,303 / p 1e-285 | 5.5 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Diabetes mellitus | 352 | 8.8 7.9–9.7ROR 9.1 · χ² 2,422 / p <1e-300 | 8.7 EB05 8.0 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.2 · 78% consumer | no trial data cached |
| Cerebrovascular accident (stroke) | 343 | 3.8 3.5–4.3ROR 3.9 · χ² 725 / p 5e-160 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Diarrhoea (diarrhea) | 341 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.435 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.9 | no trial data cached |
| Nausea | 320 | 0.8 0.7–0.9ROR 0.8 · χ² 22 / p 1e-6 | 0.8 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.8 | 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.
- Nephrogenic anaemia — n=30, PRR 12.3
- Arterial occlusive disease — n=48, PRR 11.6
- Maculopathy — n=20, PRR 10.7
- Gastrointestinal motility disorder — n=23, PRR 8.3
- Deafness — n=111, PRR 8.1
- Erysipelas — n=21, PRR 8.0
- Overweight — n=22, PRR 7.8
- Asphyxia — n=33, PRR 7.7
✓ 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 and Valsartan?
In FDA FAERS, the most frequently co-reported reaction terms for Amlodipine and Valsartan are blood pressure increased, hypertension, dizziness, malaise, fatigue, 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 Amlodipine and Valsartan have an FDA boxed warning?
No. The FDA label retrieved for Amlodipine and Valsartan has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Amlodipine and 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 df673a4d-acb8-444c-a472-c87ab8cbd366, effective 20251216; matched on
openfda.generic_name.exact:"AMLODIPINE") - 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, 1,070 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.