Felodipine side effects: what 11,323 FDA adverse event reports show
Drug class
Dihydropyridine Calcium Channel Blocker
Who reports
11,323 reports · 87% serious · 846 with death outcome · 49% female
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.
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.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
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. 1,056 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 |
|---|---|---|---|---|---|---|
| Cardiospasm | 397 | 4,708.1 3,912.3–5,665.8ROR 4,879.2 · χ² 520,883 / p <1e-300 | 1,237.3 EB05 1,138.5 · IC025 +8.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=397 | not reported in cached trials |
| Immunisation | 256 | 2,718.3 2,242.6–3,294.8ROR 2,781.1 · χ² 278,359 / p <1e-300 | 1,009.8 EB05 910.1 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious n=256 | not reported in cached trials |
| Palmoplantar keratoderma | 387 | 2,181.5 1,884.3–2,525.5ROR 2,258.6 · χ² 383,375 / p <1e-300 | 947.6 EB05 871.0 · IC025 +8.6 3/3 methods agree | Not in label — unassessed | serious n=387 | not reported in cached trials |
| Cardiopulmonary exercise test abnormal | 13 | 1,978.5 903.0–4,335.2ROR 1,980.8 · χ² 11,402 / p <1e-300 | 395.5 EB05 246.0 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=13 | not reported in cached trials |
| Pelvic misalignment | 23 | 1,615.6 922.2–2,830.5ROR 1,618.9 · χ² 18,845 / p <1e-300 | 499.5 EB05 350.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% consumer | not reported in cached trials |
| Meniscopathy | 12 | 684.9 352.8–1,329.3ROR 685.6 · χ² 5,472 / p <1e-300 | 277.9 EB05 169.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Factor vii deficiency | 13 | 448.0 244.3–821.4ROR 448.5 · χ² 4,303 / p <1e-300 | 235.6 EB05 146.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Oropharyngeal discolouration | 11 | 446.4 231.0–862.9ROR 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 | not reported in cached trials |
| Atrial tachycardia | 395 | 427.6 383.8–476.4ROR 443.0 · χ² 135,894 / p <1e-300 | 340.9 EB05 313.6 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=395 | not reported in cached trials |
| Steroid dependence | 146 | 384.8 322.2–459.5ROR 389.8 · χ² 45,845 / 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 | not reported in cached trials |
| Pruritus genital | 392 | 375.4 337.3–417.9ROR 388.8 · χ² 121,124 / p <1e-300 | 306.9 EB05 282.2 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=391 | not reported in cached trials |
| Catarrh | 149 | 373.3 313.3–444.8ROR 378.2 · χ² 45,626 / p <1e-300 | 298.2 EB05 260.2 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=149 · ♀ 18% (drug 49%) · 94% clinician | not reported in cached trials |
| Peroneal nerve injury | 13 | 239.8 134.6–427.4ROR 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 | not reported in cached trials |
| Carotid artery occlusion | 396 | 224.9 202.9–249.2ROR 233.0 · χ² 78,401 / p <1e-300 | 198.4 EB05 182.6 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=396 | not reported in cached trials |
| Sacroiliac joint dysfunction | 13 | 202.9 114.4–359.8ROR 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 | not reported in cached trials |
| Neuroglycopenia | 10 | 188.3 98.2–360.9ROR 188.4 · 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 | not reported in cached trials |
| Sleep terror | 387 | 187.7 169.4–208.1ROR 194.3 · χ² 65,022 / p <1e-300 | 168.9 EB05 155.3 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=387 | not reported in cached trials |
| Tension headache | 394 | 187.0 168.9–207.1ROR 193.8 · χ² 65,982 / p <1e-300 | 168.4 EB05 154.9 · IC025 +7.0 3/3 methods agree | Labeled (related wording) related wording | serious n=393 | not reported in cached trials |
| Burns second degree | 154 | 178.8 151.7–210.8ROR 181.3 · χ² 24,641 / p <1e-300 | 159.7 EB05 139.7 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=154 · ♀ 18% (drug 49%) · 93% clinician | not reported in cached trials |
| Neurofibroma | 13 | 178.5 101.0–315.4ROR 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 | not reported in cached trials |
| 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 | not reported in cached trials |
| Hypopnoea | 163 | 91.5 78.3–107.0ROR 92.9 · χ² 13,816 / p <1e-300 | 86.4 EB05 75.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=163 · ♀ 26% (drug 49%) · 92% clinician | not reported in cached trials |
| 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 | not reported in cached trials |
| Facial pain | 401 | 87.1 79.0–96.2ROR 90.3 · χ² 32,524 / p <1e-300 | 82.9 EB05 76.3 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=401 | not reported in cached trials |
| Subarachnoid haemorrhage | 407 | 76.8 69.7–84.7ROR 79.7 · χ² 29,172 / p <1e-300 | 73.5 EB05 67.7 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 48.6 | not reported in cached trials |
| Alcohol poisoning | 98 | 71.0 58.1–86.8ROR 71.6 · χ² 6,443 / 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 | not reported in cached trials |
| Vasculitis | 429 | 70.7 64.3–77.8ROR 73.5 · χ² 28,341 / p <1e-300 | 67.9 EB05 62.7 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 48.2 | not reported in cached trials |
| 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 | not reported in cached trials |
| Anosmia (loss of smell) | 396 | 52.0 47.1–57.3ROR 53.8 · χ² 19,211 / p <1e-300 | 50.4 EB05 46.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=394 | not reported in cached trials |
| Neurogenic shock | 14 | 48.9 28.8–83.1ROR 48.9 · χ² 594 / p 2e-131 | 44.9 EB05 28.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Bronchiectasis | 170 | 48.5 41.7–56.4ROR 49.2 · χ² 7,657 / 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%) | not reported in cached trials |
| 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 | not reported in cached trials |
| 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 | not reported in cached trials |
| Pericarditis | 416 | 47.4 43.1–52.1ROR 49.2 · χ² 18,384 / p <1e-300 | 46.1 EB05 42.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 30.7 | not reported in cached trials |
| 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 | not reported in cached trials |
| Ventricular tachycardia | 406 | 46.5 42.2–51.2ROR 48.2 · χ² 17,593 / p <1e-300 | 45.3 EB05 41.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 30.2 | not reported in cached trials |
| Vestibular neuronitis | 13 | 46.4 26.7–80.4ROR 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 | not reported in cached trials |
| 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 | not reported in cached trials |
| Scrotal oedema | 16 | 42.6 26.0–69.9ROR 42.7 · χ² 595 / p 1e-131 | 39.8 EB05 26.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Cervicobrachial syndrome | 13 | 39.6 22.8–68.5ROR 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 | 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 Felodipine 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 (0 of 40 signal terms matched).
- NCT02336607 — The Effects on Blood Pressure Control, Pulse Wave Velocity, as Well as Safety and Tolerability of Felodipine S (N=529, NA; 4 AE terms posted; arms: Felodipine Tablet (Plendil)+Metoprolol T; Felodipine Tablets (Plendil)+Lisinopril ; Felodipine Tablet (Plendil)+Hydrochlorot; Felodipine Tablet (Plendil))
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) | 1,109 | 2.6 2.5–2.8ROR 2.8 · χ² 1,176 / p 6e-258 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,001 | 3.3 3.1–3.5ROR 3.5 · χ² 1,626 / p <1e-300 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | not reported in cached trials |
| 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 | not reported in cached trials |
| Nausea | 887 | 2.1 2.0–2.2ROR 2.2 · χ² 517 / p 8e-115 | 2.1 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.4 | not reported in cached trials |
| Diarrhoea (diarrhea) | 887 | 2.6 2.4–2.7ROR 2.7 · χ² 864 / p 4e-190 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | not reported in cached trials |
| Headache | 883 | 2.6 2.5–2.8ROR 2.8 · χ² 904 / p 7e-199 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | NCT02336607: 33/260 (12.7%) on Felodipine |
| Pain | 852 | 2.6 2.4–2.7ROR 2.7 · χ² 836 / p 3e-184 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | not reported in cached trials |
| Pyrexia (fever) | 782 | 4.2 3.9–4.5ROR 4.4 · χ² 1,923 / p <1e-300 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | not reported in cached trials |
| 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 | not reported in cached trials |
| Malaise (feeling unwell) | 698 | 2.9 2.7–3.2ROR 3.1 · χ² 911 / p 2e-200 | 2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | not reported in cached trials |
| 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 | not reported in cached trials |
| 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 | not reported in cached trials |
| 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 | not reported in cached trials |
| 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 | not reported in cached trials |
| 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 | not reported in cached trials |
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 2,718.3
- Palmoplantar keratoderma — n=387, PRR 2,181.5
- Pelvic misalignment — n=23, PRR 1,615.6
- Atrial tachycardia — n=395, PRR 427.6
- Steroid dependence — n=146, PRR 384.8
- Pruritus genital — n=392, PRR 375.4
- 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?
In FDA FAERS, the most frequently co-reported reaction terms for Felodipine 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 have an FDA boxed warning?
No. The FDA label retrieved for Felodipine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Felodipine 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 0bef7cf2-012b-4804-ac93-0a8b333035db, effective 20260811; matched on
openfda.generic_name.exact:"FELODIPINE") - 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, 1,096 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, 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.