Drug · FAERS side-effect profile with label screen
Felodipine Extended-Release side effects: what 11,323 FDA adverse event reports show
Drug class
Dihydropyridine Calcium Channel Blocker
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Felodipine Extended-Release Tablets (Felodipine)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
11,323 reports · 87% serious · 846 with death outcome · 49% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Felodipine Extended-release Tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine.
FDA label, Indications and Usage
What it is
DESCRIPTION Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl) -1,4-dihydro-2, 6-dimethyl-3, 5- pyridinedicarboxylate.
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
Labeled adverse reaction 1Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 33
What the badges mean
- 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. 1,055 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 |
|---|---|---|---|---|---|---|
| Cardiospasm | 397 | 4,708.6 3,912.7–5,666.3ROR 4,879.6 · χ² 520,929 / p <1e-300 | 1,237.4 EB05 1,138.6 · IC025 +8.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=397 | no trial arm names this drug |
| Immunisation | 256 | 2,718.5 2,242.8–3,295.1ROR 2,781.4 · χ² 278,384 / p <1e-300 | 1,009.8 EB05 910.2 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious n=256 | no trial arm names this drug |
| Palmoplantar keratoderma | 387 | 2,181.6 1,884.5–2,525.7ROR 2,258.8 · χ² 383,409 / p <1e-300 | 947.7 EB05 871.1 · IC025 +8.6 3/3 methods agree | Not in label — unassessed | serious n=387 | no trial arm names this drug |
| Cardiopulmonary exercise test abnormal | 13 | 1,978.7 903.1–4,335.6ROR 1,981.0 · χ² 11,403 / p <1e-300 | 395.5 EB05 246.0 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=13 | no trial arm names this drug |
| Pelvic misalignment | 23 | 1,615.7 922.2–2,830.8ROR 1,619.0 · χ² 18,846 / p <1e-300 | 499.5 EB05 350.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% consumer | no trial arm names this drug |
| Meniscopathy | 12 | 684.9 352.9–1,329.5ROR 685.7 · χ² 5,473 / p <1e-300 | 277.9 EB05 169.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial arm names this drug |
| Factor vii deficiency | 13 | 448.0 244.3–821.5ROR 448.5 · χ² 4,304 / p <1e-300 | 235.6 EB05 146.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Oropharyngeal discolouration | 11 | 446.5 231.0–863.0ROR 446.9 · χ² 3,579 / p <1e-300 | 221.4 EB05 131.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial arm names this drug |
| Atrial tachycardia | 395 | 427.7 383.9–476.4ROR 443.1 · χ² 135,906 / p <1e-300 | 341.0 EB05 313.7 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=395 | no trial arm names this drug |
| Steroid dependence | 146 | 384.8 322.2–459.6ROR 389.8 · χ² 45,849 / p <1e-300 | 305.3 EB05 265.9 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=146 · ♀ 18% (drug 49%) · 93% clinician | no trial arm names this drug |
| Pruritus genital | 392 | 375.5 337.3–417.9ROR 388.9 · χ² 121,135 / p <1e-300 | 306.9 EB05 282.3 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=391 | no trial arm names this drug |
| Catarrh | 149 | 373.3 313.3–444.8ROR 378.3 · χ² 45,631 / p <1e-300 | 298.3 EB05 260.2 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=149 · ♀ 18% (drug 49%) · 94% clinician | no trial arm names this drug |
| Peroneal nerve injury | 13 | 239.8 134.6–427.5ROR 240.1 · χ² 2,526 / p <1e-300 | 162.1 EB05 100.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Carotid artery occlusion | 396 | 224.9 202.9–249.2ROR 233.0 · χ² 78,408 / p <1e-300 | 198.4 EB05 182.6 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=396 | no trial arm names this drug |
| Sacroiliac joint dysfunction | 13 | 202.9 114.5–359.8ROR 203.2 · χ² 2,173 / p <1e-300 | 144.5 EB05 89.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Neuroglycopenia | 10 | 188.3 98.2–360.9ROR 188.5 · χ² 1,523 / p <1e-300 | 129.3 EB05 75.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial arm names this drug |
| Sleep terror | 387 | 187.7 169.4–208.1ROR 194.4 · χ² 65,028 / p <1e-300 | 168.9 EB05 155.3 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=387 | no trial arm names this drug |
| Tension headache | 394 | 187.1 168.9–207.2ROR 193.8 · χ² 65,988 / p <1e-300 | 168.4 EB05 154.9 · IC025 +7.0 3/3 methods agree | Labeled (related wording) related wording | serious n=393 | no trial arm names this drug |
| Burns second degree | 154 | 178.8 151.7–210.8ROR 181.3 · χ² 24,643 / p <1e-300 | 159.8 EB05 139.7 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=154 · ♀ 18% (drug 49%) · 93% clinician | no trial arm names this drug |
| Neurofibroma | 13 | 178.5 101.0–315.5ROR 178.7 · χ² 1,932 / p <1e-300 | 131.7 EB05 81.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Vaccination site swelling | 11 | 128.8 69.9–237.3ROR 128.9 · χ² 1,186 / p 3e-260 | 100.0 EB05 59.6 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=11 | no trial arm names this drug |
| Hypopnoea | 163 | 91.5 78.3–107.0ROR 92.9 · χ² 13,818 / p <1e-300 | 86.4 EB05 75.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=163 · ♀ 26% (drug 49%) · 92% clinician | no trial arm names this drug |
| Merycism | 13 | 90.3 51.7–157.5ROR 90.4 · χ² 1,010 / p 5e-222 | 76.7 EB05 47.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Facial pain | 401 | 87.2 79.0–96.2ROR 90.3 · χ² 32,527 / p <1e-300 | 82.9 EB05 76.3 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=401 | no trial arm names this drug |
| Subarachnoid haemorrhage | 407 | 76.8 69.7–84.7ROR 79.7 · χ² 29,175 / p <1e-300 | 73.5 EB05 67.7 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 48.6 | no trial arm names this drug |
| Alcohol poisoning | 98 | 71.0 58.1–86.8ROR 71.6 · χ² 6,444 / p <1e-300 | 67.5 EB05 57.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=98 · ♀ 0% (drug 49%) · 96% clinician | no trial arm names this drug |
| Vasculitis | 429 | 70.7 64.3–77.8ROR 73.5 · χ² 28,344 / p <1e-300 | 67.9 EB05 62.7 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 48.2 | no trial arm names this drug |
| Myosclerosis | 13 | 67.3 38.7–117.0ROR 67.3 · χ² 756 / p 1e-166 | 59.5 EB05 37.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Anosmia (loss of smell) | 396 | 52.0 47.1–57.3ROR 53.8 · χ² 19,212 / p <1e-300 | 50.4 EB05 46.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=394 | no trial arm names this drug |
| Neurogenic shock | 14 | 48.9 28.8–83.1ROR 49.0 · χ² 594 / p 2e-131 | 44.9 EB05 28.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Bronchiectasis | 170 | 48.5 41.7–56.4ROR 49.2 · χ² 7,658 / p <1e-300 | 47.0 EB05 41.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=170 · ♀ 22% (drug 49%) | no trial arm names this drug |
| Joint hyperextension | 10 | 48.2 25.7–90.3ROR 48.2 · χ² 405 / p 2e-90 | 43.4 EB05 25.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial arm names this drug |
| Patellofemoral pain syndrome | 13 | 47.9 27.6–83.0ROR 47.9 · χ² 537 / p 5e-119 | 43.9 EB05 27.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Pericarditis | 416 | 47.4 43.1–52.2ROR 49.2 · χ² 18,385 / p <1e-300 | 46.1 EB05 42.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 30.7 | no trial arm names this drug |
| Nail bed bleeding | 14 | 46.9 27.6–79.7ROR 47.0 · χ² 569 / p 4e-126 | 43.3 EB05 27.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Ventricular tachycardia | 406 | 46.5 42.2–51.2ROR 48.2 · χ² 17,595 / p <1e-300 | 45.3 EB05 41.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 30.2 | no trial arm names this drug |
| Vestibular neuronitis | 13 | 46.4 26.8–80.4ROR 46.4 · χ² 519 / p 3e-115 | 42.6 EB05 26.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Helicobacter test positive | 13 | 44.1 25.5–76.5ROR 44.2 · χ² 494 / p 1e-109 | 40.7 EB05 25.3 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial arm names this drug |
| Scrotal oedema | 16 | 42.6 26.0–69.9ROR 42.7 · χ² 595 / p 9e-132 | 39.8 EB05 26.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial arm names this drug |
| Cervicobrachial syndrome | 13 | 39.6 22.9–68.5ROR 39.6 · χ² 441 / p 3e-98 | 36.8 EB05 22.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Felodipine Extended-Release (searched FELODIPINE EXTENDED-RELEASE).
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) | 1,109 | 2.6 2.5–2.8ROR 2.8 · χ² 1,176 / p 5e-258 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 1,001 | 3.3 3.1–3.5ROR 3.5 · χ² 1,627 / p <1e-300 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial arm names this drug |
| Dizziness | 1,000 | 3.7 3.5–4.0ROR 4.0 · χ² 2,035 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial arm names this drug |
| Nausea | 887 | 2.1 2.0–2.2ROR 2.2 · χ² 517 / p 7e-115 | 2.1 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.4 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 887 | 2.6 2.4–2.7ROR 2.7 · χ² 864 / p 3e-190 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial arm names this drug |
| Headache | 883 | 2.6 2.5–2.8ROR 2.8 · χ² 904 / p 6e-199 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial arm names this drug |
| Pain | 852 | 2.6 2.4–2.7ROR 2.7 · χ² 837 / p 3e-184 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial arm names this drug |
| Pyrexia (fever) | 782 | 4.2 3.9–4.5ROR 4.4 · χ² 1,924 / p <1e-300 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial arm names this drug |
| Vomiting | 736 | 2.9 2.7–3.1ROR 3.0 · χ² 940 / p 8e-207 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial arm names this drug |
| Malaise (feeling unwell) | 698 | 2.9 2.7–3.2ROR 3.1 · χ² 912 / p 1e-200 | 2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial arm names this drug |
| Off label use (used outside approved label) | 693 | 1.5 1.4–1.6ROR 1.5 · χ² 112 / p 2e-26 | 1.5 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.7 | no trial arm names this drug |
| Arthralgia (joint pain) | 693 | 3.1 2.9–3.3ROR 3.2 · χ² 1,002 / p 3e-220 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial arm names this drug |
| Palpitations (pounding heartbeat) | 687 | 10.9 10.2–11.8ROR 11.6 · χ² 6,187 / p <1e-300 | 10.9 EB05 10.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial arm names this drug |
| Pruritus (itching) | 661 | 3.2 3.0–3.5ROR 3.4 · χ² 1,040 / p 2e-228 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial arm names this drug |
| Abdominal discomfort | 631 | 7.0 6.5–7.6ROR 7.4 · χ² 3,261 / p <1e-300 | 7.0 EB05 6.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial arm names this drug |
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.
- Immunisation — n=256, PRR 2,718.5
- Palmoplantar keratoderma — n=387, PRR 2,181.6
- Pelvic misalignment — n=23, PRR 1,615.7
- Atrial tachycardia — n=395, PRR 427.7
- Steroid dependence — n=146, PRR 384.8
- Pruritus genital — n=392, PRR 375.5
- Catarrh — n=149, PRR 373.3
- Carotid artery occlusion — n=396, PRR 224.9
- Sleep terror — n=387, PRR 187.7
- Burns second degree — n=154, PRR 178.8
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 Felodipine Extended-Release?
In FDA FAERS, the most frequently co-reported reaction terms for Felodipine Extended-Release are fatigue, dyspnoea, dizziness, 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 Felodipine Extended-Release have an FDA boxed warning?
No. The FDA label retrieved for Felodipine Extended-Release has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Felodipine Extended-Release 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 7990a581-3e0f-5d8c-e053-2991aa0aa6a7, effective 20251229; matched on
openfda.generic_name.exact:"FELODIPINE EXTENDED-RELEASE TABLETS") - 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, 1,095 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
FELODIPINE EXTENDED-RELEASE, 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.