Drug · FAERS side-effect profile with label screen
Amlodipine side effects: what 267,918 FDA adverse event reports show
Drug class
Calcium channel blocker and may be
FDA label, Indications wording
Brand names
Katerzia
openFDA label
Who reports
267,918 reports · 77% serious · 29,515 with death outcome · 53% 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
Amlodipine is a fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative, which is used for the treatment of hypertension, chronic stable angina and confirmed or suspected vasospastic angina.
PubChem CID 2162 (ChEBI)
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 12Reporting / coding artifact 1Lab value / disease marker 1Outcome field, not a reaction 1Not in label — unassessed 25
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.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 1,114 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 |
|---|---|---|---|---|---|---|
| Distributive shock | 756 | 40.4 37.0–44.2ROR 40.5 · χ² 18,972 / p <1e-300 | 26.7 EB05 25.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=756 · 100% clinician | not reported in cached trials |
| Non-cardiogenic pulmonary oedema | 362 | 40.2 35.4–45.7ROR 40.3 · χ² 9,036 / p <1e-300 | 26.6 EB05 24.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=362 · 100% clinician | not reported in cached trials |
| Vasoplegia syndrome | 521 | 37.0 33.3–41.1ROR 37.1 · χ² 12,262 / p <1e-300 | 25.2 EB05 23.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=521 · 100% clinician | not reported in cached trials |
| Gingival hypertrophy | 446 | 32.8 29.4–36.7ROR 32.9 · χ² 9,593 / p <1e-300 | 23.2 EB05 21.5 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=401 · 100% clinician | not reported in cached trials |
| Hyperparathyroidism secondary | 546 | 21.3 19.4–23.4ROR 21.3 · χ² 8,243 / p <1e-300 | 16.9 EB05 15.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=543 | NCT00170950: 1/5,757 (0.0%) on Amlodipine (serious AE) |
| Nephrogenic anaemia | 961 | 20.0 18.7–21.5ROR 20.1 · χ² 13,758 / p <1e-300 | 16.1 EB05 15.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=961 | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 221 | 20.0 17.3–23.2ROR 20.0 · χ² 3,149 / p <1e-300 | 16.0 EB05 14.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=221 | not reported in cached trials |
| Carotid artery thrombosis | 164 | 18.4 15.5–21.8ROR 18.4 · χ² 2,160 / p <1e-300 | 15.0 EB05 13.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=164 · ♀ 100% (drug 53%) · 100% clinician | not reported in cached trials |
| Brash syndrome | 245 | 17.1 14.9–19.6ROR 17.1 · χ² 3,015 / p <1e-300 | 14.1 EB05 12.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=245 · 100% clinician | not reported in cached trials |
| Suspected suicide | 787 | 15.3 14.2–16.5ROR 15.3 · χ² 8,752 / p <1e-300 | 12.9 EB05 12.2 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=787 · 100% clinician | not reported in cached trials |
| Blood pressure systolic abnormal | 333 | 11.9 10.6–13.4ROR 12.0 · χ² 2,877 / p <1e-300 | 10.4 EB05 9.5 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious n=321 · 100% clinician | not reported in cached trials |
| Adjustment disorder | 166 | 11.3 9.6–13.3ROR 11.3 · χ² 1,345 / p 9e-295 | 9.8 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=165 · ♀ 100% (drug 53%) · 100% clinician | not reported in cached trials |
| Blood pressure diastolic abnormal | 308 | 10.5 9.3–11.9ROR 10.5 · χ² 2,326 / p <1e-300 | 9.3 EB05 8.5 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications | serious n=298 · ♀ 100% (drug 53%) · 100% clinician | not reported in cached trials |
| Rebound acid hypersecretion | 347 | 9.9 8.8–11.0ROR 9.9 · χ² 2,441 / p <1e-300 | 8.8 EB05 8.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=346 | not reported in cached trials |
| Physical deconditioning | 276 | 9.6 8.5–10.9ROR 9.6 · χ² 1,876 / p <1e-300 | 8.5 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=276 | not reported in cached trials |
| End stage renal disease | 1,985 | 9.3 8.9–9.8ROR 9.4 · χ² 13,176 / p <1e-300 | 8.4 EB05 8.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | not reported in cached trials |
| Sedation complication | 264 | 9.1 8.0–10.4ROR 9.1 · χ² 1,699 / p <1e-300 | 8.2 EB05 7.4 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=262 · ♀ 100% (drug 53%) · 100% clinician | not reported in cached trials |
| Creatinine renal clearance decreased | 320 | 6.7 5.9–7.5ROR 6.7 · χ² 1,413 / p <1e-300 | 6.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious n=314 · ♀ 100% (drug 53%) | not reported in cached trials |
| Shock | 1,770 | 6.5 6.2–6.8ROR 6.5 · χ² 7,595 / p <1e-300 | 6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 96% clinician | NCT00170950: 3/5,740 (0.1%) on Amlodipine (serious AE) |
| Diastolic dysfunction | 232 | 6.2 5.5–7.1ROR 6.3 · χ² 940 / p 8e-207 | 5.8 EB05 5.2 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=232 · 100% clinician | not reported in cached trials |
| Blood pressure inadequately controlled | 449 | 6.2 5.6–6.8ROR 6.2 · χ² 1,799 / p <1e-300 | 5.8 EB05 5.3 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=369 | NCT00170950: 1/5,757 (0.0%) on Amlodipine (serious AE) |
| Personality disorder | 193 | 6.1 5.3–7.1ROR 6.1 · χ² 758 / p 3e-167 | 5.7 EB05 5.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=187 · ♀ 100% (drug 53%) · 100% clinician | not reported in cached trials |
| Blood pressure systolic increased | 1,428 | 6.1 5.8–6.4ROR 6.1 · χ² 5,610 / p <1e-300 | 5.7 EB05 5.4 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.4 | not reported in cached trials |
| Hypomagnesaemia | 982 | 5.9 5.5–6.3ROR 5.9 · χ² 3,697 / p <1e-300 | 5.5 EB05 5.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 90% clinician | NCT00170950: 2/5,757 (0.0%) on Amlodipine (serious AE) |
| Chronic kidney disease | 5,408 | 5.9 5.7–6.0ROR 6.0 · χ² 20,349 / p <1e-300 | 5.5 EB05 5.4 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.2 | not reported in cached trials |
| Left ventricular hypertrophy | 301 | 5.8 5.2–6.6ROR 5.8 · χ² 1,117 / p 4e-245 | 5.5 EB05 5.0 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=298 · 100% clinician | not reported in cached trials |
| Orthostatic hypotension (dizziness on standing) | 1,198 | 5.7 5.4–6.0ROR 5.7 · χ² 4,317 / p <1e-300 | 5.4 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | NCT00170950: 5/5,740 (0.1%) on Amlodipine (serious AE) |
| Atrioventricular block first degree | 299 | 5.7 5.1–6.4ROR 5.7 · χ² 1,072 / p 2e-235 | 5.3 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=293 · 100% clinician | NCT00170950: 1/5,740 (0.0%) on Amlodipine (serious AE) |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | 165 | 5.6 4.8–6.6ROR 5.6 · χ² 578 / p 5e-128 | 5.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=163 · ♀ 100% (drug 53%) · 100% clinician | not reported in cached trials |
| Breath sounds abnormal | 333 | 5.6 5.0–6.3ROR 5.6 · χ² 1,167 / p 5e-256 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=326 | not reported in cached trials |
| Metabolic acidosis | 2,118 | 5.5 5.3–5.8ROR 5.6 · χ² 7,358 / p <1e-300 | 5.2 EB05 5.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | NCT00170950: 1/5,740 (0.0%) on Amlodipine (serious AE) |
| Completed suicide (death by suicide) | 5,533 | 5.4 5.3–5.6ROR 5.5 · χ² 18,790 / p <1e-300 | 5.1 EB05 5.0 · IC025 +2.3 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.8 · 100% clinician | NCT00170950: 1/5,740 (0.0%) on Amlodipine (serious AE) |
| Cardiogenic shock | 922 | 5.3 5.0–5.7ROR 5.4 · χ² 3,036 / p <1e-300 | 5.0 EB05 4.8 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.8 · 100% clinician | NCT00170950: 3/5,740 (0.1%) on Amlodipine (serious AE) |
| Acute kidney injury (sudden kidney damage) | 9,810 | 5.3 5.2–5.4ROR 5.5 · χ² 32,413 / p <1e-300 | 5.0 EB05 5.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | not reported in cached trials |
| Aplastic anaemia | 336 | 5.3 4.7–5.9ROR 5.3 · χ² 1,090 / p 3e-239 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=336 · 100% clinician | not reported in cached trials |
| Blood pressure diastolic decreased | 461 | 5.1 4.7–5.6ROR 5.1 · χ² 1,430 / p <1e-300 | 4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.7 | not reported in cached trials |
| Hypertensive crisis | 677 | 5.0 4.6–5.4ROR 5.0 · χ² 2,024 / p <1e-300 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.5 | NCT00170950: 1/5,740 (0.0%) on Amlodipine (serious AE) |
| Potentiating drug interaction | 193 | 4.8 4.2–5.6ROR 4.8 · χ² 547 / p 2e-121 | 4.6 EB05 4.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=188 · ♀ 0% (drug 53%) · 100% clinician | not reported in cached trials |
| Gingival swelling | 257 | 4.8 4.2–5.4ROR 4.8 · χ² 721 / p 5e-159 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=219 | not reported in cached trials |
| Haemodynamic instability | 432 | 4.7 4.3–5.2ROR 4.7 · χ² 1,192 / p 2e-261 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 100% clinician | 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 Amlodipine 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 (10 of 40 signal terms matched).
- NCT01252563 — Amlodipine 10mg Drug Use Investigation (N=14141, phase n/a; 70 AE terms posted; arms: Amlodipine 10 mg Tablet)
- NCT00170950 — Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension (N=11506, PHASE3; 1077 AE terms posted; arms: Benazepril / Amlodipine; Benazepril / HCTZ)
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 16,328 | 1.7 1.6–1.7ROR 1.7 · χ² 4,339 / p <1e-300 | 1.6 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT00170950: 3/5,740 (0.1%) on Amlodipine (serious AE) |
| Diarrhoea (diarrhea) | 14,641 | 1.8 1.8–1.8ROR 1.8 · χ² 5,240 / p <1e-300 | 1.8 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.6 | NCT00170950: 17/5,740 (0.3%) on Amlodipine (serious AE) |
| Nausea | 13,903 | 1.4 1.4–1.4ROR 1.4 · χ² 1,523 / p <1e-300 | 1.4 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT00170950: 9/5,740 (0.2%) on Amlodipine (serious AE) |
| Dyspnoea (shortness of breath) | 13,612 | 1.9 1.9–1.9ROR 2.0 · χ² 5,869 / p <1e-300 | 1.9 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.6 | NCT00170950: 40/5,740 (0.7%) on Amlodipine (serious AE) |
| Drug ineffective (drug did not work) | 12,577 | 0.7 0.7–0.8ROR 0.7 · χ² 1,160 / p 1e-254 | 0.7 EB05 0.7 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Off label use (used outside approved label) | 11,795 | 1.1 1.0–1.1ROR 1.1 · χ² 47 / p 3e-12 | 1.1 EB05 1.0 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.1 | not reported in cached trials |
| Dizziness | 11,066 | 1.8 1.7–1.8ROR 1.8 · χ² 3,607 / p <1e-300 | 1.7 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT01252563: 45/13,343 (0.3%) on Amlodipine |
| Headache | 10,247 | 1.3 1.3–1.3ROR 1.3 · χ² 657 / p 3e-145 | 1.3 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.4 | NCT01252563: 14/13,343 (0.1%) on Amlodipine |
| Acute kidney injury (sudden kidney damage) | 9,810 | 5.3 5.2–5.4ROR 5.5 · χ² 32,413 / p <1e-300 | 5.0 EB05 5.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | not reported in cached trials |
| Pain | 9,463 | 1.2 1.2–1.2ROR 1.2 · χ² 339 / p 4e-76 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.1 | NCT00170950: 21/5,740 (0.4%) on Amlodipine (serious AE) |
| Vomiting | 9,121 | 1.5 1.5–1.6ROR 1.6 · χ² 1,693 / p <1e-300 | 1.5 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.4 | NCT00170950: 13/5,740 (0.2%) on Amlodipine (serious AE) |
| Fall | 8,788 | 2.1 2.1–2.1ROR 2.1 · χ² 4,990 / p <1e-300 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.7 | NCT00170950: 13/5,740 (0.2%) on Amlodipine (serious AE) |
| Asthenia (weakness) | 8,735 | 1.8 1.8–1.9ROR 1.9 · χ² 3,313 / p <1e-300 | 1.8 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.5 | NCT00170950: 9/5,740 (0.2%) on Amlodipine (serious AE) |
| Hypotension (low blood pressure) | 8,661 | 3.5 3.4–3.6ROR 3.6 · χ² 14,872 / p <1e-300 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | NCT01252563: 1/13,343 (0.0%) on Amlodipine (serious AE) |
| Malaise (feeling unwell) | 8,223 | 1.5 1.4–1.5ROR 1.5 · χ² 1,250 / p 5e-274 | 1.5 EB05 1.4 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.5 | NCT01252563: 1/13,343 (0.0%) on Amlodipine (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.
- Distributive shock — n=756, PRR 40.4
- Non-cardiogenic pulmonary oedema — n=362, PRR 40.2
- Vasoplegia syndrome — n=521, PRR 37.0
- Hyperparathyroidism secondary — n=546, PRR 21.3 (also seen in trial arm)
- Nephrogenic anaemia — n=961, PRR 20.0
- Chronic kidney disease-mineral and bone disorder — n=221, PRR 20.0
- Carotid artery thrombosis — n=164, PRR 18.4
- Brash syndrome — n=245, PRR 17.1
- Adjustment disorder — n=166, PRR 11.3
- Rebound acid hypersecretion — n=347, PRR 9.9
✓ 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?
In FDA FAERS, the most frequently co-reported reaction terms for Amlodipine are fatigue, diarrhoea, nausea, dyspnoea, dizziness, 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 Amlodipine have an FDA boxed warning?
No. The FDA label retrieved for Amlodipine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Amlodipine 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" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 2162 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, 1,154 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
AMLODIPINE, 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.