Drug · FAERS side-effect profile with label screen

Amiodarone side effects: what 11,133 FDA adverse event reports show

Amiodarone Hydrochloride · 1,118 reaction terms · 58,984 drug–reaction co-reports · data 2026-09-14

Drug class

Antiarrhythmic agent

FDA label, Indications wording of the closest related product

Label matched

Amiodarone Hydrochloride (Amiodarone Hydrochloride)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

11,133 reports · 86% serious · 1,934 with death outcome · 39% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication.

FDA label, Indications and Usage

What it is

Amiodarone Hydrochloride Injection, USP contains amiodarone HCl (C 25 H 29 I 2 NO 3 •HCl), a class III antiarrhythmic drug. Amiodarone HCl is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride.

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 4Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 5Lab value / disease marker 3Not in label — unassessed 24

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. 1,078 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Appendicolith	201	2,144.6 1,752.2–2,624.9ROR 2,184.0 · χ² 198,836 / p <1e-300	908.8 EB05 808.1 · IC025 +7.9 3/3 methods agree	Not in label — unassessed	serious n=201 · ♀ 0% (drug 39%) · 96% clinician	not reported in cached trials
Sleep disorder therapy	91	1,816.6 1,361.5–2,423.9ROR 1,831.5 · χ² 82,546 / p <1e-300	769.0 EB05 645.3 · IC025 +6.9 3/3 methods agree	Reporting / coding artifact	serious n=91 · ♀ 0% (drug 39%) · 100% clinician	not reported in cached trials
Antacid therapy	53	1,490.8 1,039.0–2,139.1ROR 1,498.0 · χ² 42,942 / p <1e-300	636.1 EB05 504.9 · IC025 +6.1 3/3 methods agree	Reporting / coding artifact	serious n=53 · ♀ 0% (drug 39%) · 100% clinician	not reported in cached trials
Femoral hernia incarcerated	27	1,113.9 691.5–1,794.3ROR 1,116.6 · χ² 18,074 / p <1e-300	465.7 EB05 336.1 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=27 · ♀ 100% (drug 39%) · 100% clinician	not reported in cached trials
Analgesic therapy	98	887.5 698.1–1,128.2ROR 895.4 · χ² 58,114 / p <1e-300	537.4 EB05 453.9 · IC025 +6.9 3/3 methods agree	Reporting / coding artifact	serious n=98 · ♀ 0% (drug 39%) · 95% clinician	not reported in cached trials
Drug therapy	92	762.5 598.6–971.3ROR 768.8 · χ² 49,058 / p <1e-300	485.9 EB05 408.1 · IC025 +6.8 3/3 methods agree	Reporting / coding artifact	serious n=92 · ♀ 0% (drug 39%) · 93% clinician	not reported in cached trials
Lymphatic fistula	27	696.2 447.5–1,083.1ROR 697.9 · χ² 13,130 / p <1e-300	372.5 EB05 268.9 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=27 · ♀ 100% (drug 39%) · 100% clinician	not reported in cached trials
Congenital hiatus hernia	53	592.7 435.3–807.1ROR 595.6 · χ² 23,286 / p <1e-300	386.6 EB05 306.9 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=53 · ♀ 0% (drug 39%) · 100% clinician	not reported in cached trials
Malignant melanoma stage 0	43	587.0 416.8–826.7ROR 589.3 · χ² 18,669 / p <1e-300	372.1 EB05 287.8 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=43 · ♀ 0% (drug 39%) · 100% clinician	not reported in cached trials
Anticoagulant therapy	53	445.2 330.1–600.5ROR 447.4 · χ² 18,591 / p <1e-300	318.0 EB05 252.4 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	serious n=53 · ♀ 0% (drug 39%) · 92% clinician	not reported in cached trials
Bacteroides infection	32	265.2 183.2–383.9ROR 266.0 · χ² 7,141 / p <1e-300	204.0 EB05 151.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=32 · ♀ 0% (drug 39%) · 100% clinician	not reported in cached trials
Infusion site phlebitis	28	262.5 176.8–389.8ROR 263.2 · χ² 6,164 / p <1e-300	199.0 EB05 144.5 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious n=28 · 100% clinician	not reported in cached trials
Myxoedema coma	32	217.6 151.0–313.7ROR 218.2 · χ² 5,983 / p <1e-300	174.7 EB05 129.6 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=32 · ♀ 62% (drug 39%) · 100% clinician	not reported in cached trials
Arrhythmic storm	33	209.8 146.5–300.6ROR 210.4 · χ² 5,975 / p <1e-300	170.2 EB05 126.8 · IC025 +5.1 3/3 methods agree	Labeled (related wording) related wording	serious n=33 · ♀ 12% (drug 39%) · 100% clinician	not reported in cached trials
Deposit eye	26	201.1 134.2–301.3ROR 201.6 · χ² 4,492 / p <1e-300	160.4 EB05 115.0 · IC025 +4.7 3/3 methods agree	Labeled (related wording) related wording	serious n=21	not reported in cached trials
Pancreatic steatosis	23	177.9 116.0–272.8ROR 178.3 · χ² 3,533 / p <1e-300	143.4 EB05 100.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=23 · ♀ 100% (drug 39%) · 100% clinician	not reported in cached trials
Wound infection pseudomonas	26	171.2 114.6–255.7ROR 171.6 · χ² 3,873 / p <1e-300	140.8 EB05 101.0 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=26 · ♀ 100% (drug 39%) · 100% clinician	not reported in cached trials
Decompensated hypothyroidism	10	149.7 78.6–285.1ROR 149.9 · χ² 1,233 / p 2e-270	110.1 EB05 63.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Pulmonary toxicity	407	115.9 105.0–127.9ROR 120.2 · χ² 43,533 / p <1e-300	108.6 EB05 100.0 · IC025 +6.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 73.5	not reported in cached trials
Hyperphosphataemia	115	108.0 89.6–130.2ROR 109.1 · χ² 11,420 / p <1e-300	100.4 EB05 86.0 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=115 · ♀ 0% (drug 39%) · 96% clinician	not reported in cached trials
Blood phosphorus increased	146	106.5 90.3–125.8ROR 107.9 · χ² 14,339 / p <1e-300	99.5 EB05 86.7 · IC025 +6.0 3/3 methods agree	Lab value / disease marker	serious n=146 · ♀ 3% (drug 39%) · 95% clinician	not reported in cached trials
Thyrotoxic crisis	58	101.8 78.2–132.5ROR 102.3 · χ² 5,392 / p <1e-300	93.6 EB05 75.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=58 · ♀ 18% (drug 39%) · 100% clinician	not reported in cached trials
Bronchopulmonary aspergillosis allergic	47	101.7 75.9–136.3ROR 102.1 · χ² 4,348 / p <1e-300	92.9 EB05 72.7 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=47 · ♀ 0% (drug 39%) · 100% clinician	not reported in cached trials
Congestive hepatopathy	21	93.3 60.2–144.5ROR 93.4 · χ² 1,738 / p <1e-300	82.4 EB05 56.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=21	not reported in cached trials
Intensive care unit acquired weakness	17	87.7 53.9–142.5ROR 87.8 · χ² 1,309 / p 5e-287	76.8 EB05 50.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Endometrial disorder	17	82.4 50.7–133.9ROR 82.5 · χ² 1,232 / p 3e-270	72.7 EB05 48.1 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Corneal deposits	21	55.2 35.8–85.2ROR 55.3 · χ² 1,034 / p 4e-227	51.3 EB05 35.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Lymphoid tissue hyperplasia	10	54.3 29.0–101.8ROR 54.3 · χ² 458 / p 8e-102	48.2 EB05 28.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Thyroxine free increased	17	51.0 31.5–82.5ROR 51.1 · χ² 763 / p 3e-168	47.2 EB05 31.2 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=17	not reported in cached trials
Arterial haemorrhage	30	50.4 35.1–72.5ROR 50.6 · χ² 1,368 / p 1e-299	47.7 EB05 35.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=30 · ♀ 100% (drug 39%)	not reported in cached trials
Enterococcus test positive	17	50.3 31.1–81.5ROR 50.4 · χ² 753 / p 4e-166	46.6 EB05 30.8 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=17	not reported in cached trials
Ventricular fibrillation	284	49.2 43.8–55.3ROR 50.5 · χ² 13,035 / p <1e-300	47.8 EB05 43.4 · IC025 +5.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 32.4 · ♀ 12% (drug 39%) · 93% clinician	not reported in cached trials
Hyperthyroidism	361	48.2 43.5–53.4ROR 49.7 · χ² 16,215 / p <1e-300	46.9 EB05 42.9 · IC025 +5.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 33.3 · 93% clinician	not reported in cached trials
Eosinophilic pneumonia acute	20	44.7 28.7–69.6ROR 44.8 · χ² 792 / p 2e-174	42.0 EB05 28.7 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=20 · 100% clinician	not reported in cached trials
Appendicitis	207	42.9 37.4–49.1ROR 43.6 · χ² 8,234 / p <1e-300	41.8 EB05 37.2 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 28.6 · ♀ 0% (drug 39%) · 96% clinician	not reported in cached trials
Cardiogenic shock	314	42.3 37.9–47.3ROR 43.5 · χ² 12,359 / p <1e-300	41.3 EB05 37.6 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.8 · ♀ 19% (drug 39%) · 94% clinician	not reported in cached trials
Iron deficiency	96	41.5 33.9–50.8ROR 41.9 · χ² 3,674 / p <1e-300	40.3 EB05 34.0 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=94 · ♀ 0% (drug 39%) · 92% clinician	not reported in cached trials
Total lung capacity decreased	34	40.8 29.1–57.3ROR 40.9 · χ² 1,253 / p 9e-275	39.1 EB05 29.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=34 · ♀ 0% (drug 39%) · 100% clinician	not reported in cached trials
Aortic stenosis	73	40.3 32.0–50.7ROR 40.5 · χ² 2,699 / p <1e-300	39.1 EB05 32.1 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=73 · ♀ 16% (drug 39%)	not reported in cached trials
Jugular vein distension	12	40.2 22.7–71.2ROR 40.3 · χ² 412 / p 8e-92	37.3 EB05 22.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=12	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 Amiodarone 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).

NCT01401647 — Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachyca (N=3024, PHASE3; 5 AE terms posted; arms: Amiodarone; Lidocaine; Normal Saline)

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
Dyspnoea (shortness of breath)	1,201	4.0 3.8–4.2ROR 4.4 · χ² 2,772 / p <1e-300	4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.4	not reported in cached trials
Asthenia (weakness)	998	5.0 4.7–5.3ROR 5.4 · χ² 3,245 / p <1e-300	5.0 EB05 4.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	not reported in cached trials
Fatigue (tiredness)	929	2.3 2.1–2.4ROR 2.4 · χ² 670 / p 5e-148	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 2.5	not reported in cached trials
Off label use (used outside approved label)	892	1.9 1.8–2.1ROR 2.0 · χ² 419 / p 2e-93	1.9 EB05 1.8 · IC025 +0.8	Reporting / coding artifact	serious PRR 2.3	not reported in cached trials
Drug ineffective (drug did not work)	746	1.1 1.0–1.1ROR 1.1 · χ² 3 / p 0.036	1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.8	not reported in cached trials
Product use in unapproved indication	683	5.3 4.9–5.7ROR 5.6 · χ² 2,383 / p <1e-300	5.2 EB05 4.9 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 7.7	not reported in cached trials
Nausea	648	1.5 1.4–1.7ROR 1.6 · χ² 129 / p 3e-30	1.5 EB05 1.4 · IC025 +0.5	Labeled adverse reaction exact term	serious PRR 1.7	not reported in cached trials
Atrial fibrillation	625	12.1 11.2–13.1ROR 12.8 · χ² 6,362 / p <1e-300	12.0 EB05 11.3 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.3	not reported in cached trials
Cough	617	4.2 3.9–4.5ROR 4.3 · χ² 1,493 / p <1e-300	4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.6	not reported in cached trials
Dizziness	593	2.2 2.1–2.4ROR 2.3 · χ² 417 / p 6e-93	2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.3	not reported in cached trials
Pneumonia (lung infection)	562	3.3 3.0–3.6ROR 3.4 · χ² 899 / p 8e-198	3.3 EB05 3.0 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.3	NCT01401647: 103/972 (10.6%) on Amiodarone
Hypotension (low blood pressure)	499	4.7 4.3–5.1ROR 4.9 · χ² 1,460 / p <1e-300	4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.5	NCT01401647: 118/972 (12.1%) on Amiodarone
Vomiting	494	2.0 1.8–2.2ROR 2.0 · χ² 245 / p 1e-55	2.0 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 1.8	not reported in cached trials
Drug interaction	471	5.6 5.1–6.1ROR 5.8 · χ² 1,784 / p <1e-300	5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.1	not reported in cached trials
Anaemia (low red blood cells)	411	4.1 3.7–4.5ROR 4.2 · χ² 952 / p 3e-209	4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.0	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.

Appendicolith — n=201, PRR 2,144.6
Femoral hernia incarcerated — n=27, PRR 1,113.9
Lymphatic fistula — n=27, PRR 696.2
Congenital hiatus hernia — n=53, PRR 592.7
Malignant melanoma stage 0 — n=43, PRR 587.0
Bacteroides infection — n=32, PRR 265.2
Pancreatic steatosis — n=23, PRR 177.9
Wound infection pseudomonas — n=26, PRR 171.2
Hyperphosphataemia — n=115, PRR 108.0
Thyrotoxic crisis — n=58, PRR 101.8

✓ A hand-written Bradford Hill causality assessment exists for this drug: Amiodarone ↔ Pulmonary fibrosis (interstitial lung disease).

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 Amiodarone?

In FDA FAERS, the most frequently co-reported reaction terms for Amiodarone are dyspnoea, asthenia, fatigue, nausea, atrial fibrillation, cough. 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 Amiodarone have an FDA boxed warning?

No. The FDA label retrieved for Amiodarone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Amiodarone 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 1f00c333-9667-4ebc-8849-009a3779c0c9, effective 20210826; matched on openfda.generic_name.exact:"AMIODARONE HYDROCHLORIDE")
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, field patient.drug.openfda.generic_name.exact, 1,118 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 AMIODARONE, 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.