What the label lists and what reports show
Amiodarone side effects
Amiodarone's FDA label: “The most common reactions (>1%) leading to discontinuation of amiodarone hydrochloride include pulmonary toxicity, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes.” FAERS holds 11,139 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (1,201 reports).
- Generic listed
- Boxed warning
Check it at the source: the amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of amiodarone hydrochloride tablets?Amiodarone hydrochloride tablets can cause serious side effects, including: See "What is the most important information I should know about amiodarone hydrochloride tablets?" Nerve problems. Amiodarone hydrochloride tablets can cause nerve problems. Call your healthcare provider if you develop symptoms of nerve problems, including: a feeling of "pins and needles" or numbness in your hands, legs, or feet, muscle weakness, uncontrolled movements, poor coordination, or trouble walking. Skin problems. Amiodarone hydrochloride tablets can cause your skin to be more sensitive to the sun or turn a bluish-gray color. People who have fair skin or people who have a lot of sun exposure may be more at risk for these skin problems. Some of the bluish-gray skin color may return to normal after stopping amiodarone hydrochloride tablets. Thyroid problems. […]
Source: FDA drug label, Chartwell RX, LLC, effective December 9, 2025 (SPL set 5520f11d-968d-4f4f-bf57-d14369c0d746), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common reactions (>1%) leading to discontinuation of amiodarone hydrochloride include pulmonary toxicity, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the Amiodarone Hydrochloride label published by Zhejiang Poly Pharm. Co., Ltd. of January 16, 2026; the label quoted above does not print one.
| Study Event | Controlled Studies (n = 814) | Open-Label Studies (n = 1022) | Total (n = 1836) |
|---|---|---|---|
| Fever | 24 (2.9%) | 13 (1.2%) | 37 (2.0%) |
| Bradycardia | 49 (6.0%) | 41 (4.0%) | 90 (4.9%) |
| Congestive heart failure | 18 (2.2%) | 21 (2.0%) | 39 (2.1%) |
| Heart arrest | 29 (3.5%) | 26 (2.5%) | 55 (2.9%) |
| Hypotension | 165 (20.2%) | 123 (12.0%) | 288 (15.6%) |
| Ventricular tachycardia | 15 (1.8%) | 30 (2.9%) | 45 (2.4%) |
| Liver function tests abnormal | 35 (4.2%) | 29 (2.8%) | 64 (3.4%) |
| Nausea | 29 (3.5%) | 43 (4.2%) | 72 (3.9%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described in more detail in other sections of the prescribing information: Pulmonary Toxicity [see Warnings and Precautions (5.2) ] Hepatic Injury [see Warnings and Precautions (5.3) ] Worsened Arrhythmia [see Warnings and Precautions (5.4) ] Visual Impairment and Loss of Vision [see Warnings and Precautions (5.5) ] Thyroid Abnormalities [see Warnings and Precautions (5.6) ] Bradycardia [see Warnings and Precautions (5.7) ] Peripheral Neuropathy [see Warnings and Precautions (5.10) ] Photosensitivity and Skin Discoloration [see Warnings and Precautions (5.11 )] The most common reactions (>1%) leading to discontinuation of amiodarone hydrochloride include pulmonary toxicity, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Chartwell RX, LLC, effective December 9, 2025 (SPL set 5520f11d-968d-4f4f-bf57-d14369c0d746), via openFDA; the full label on DailyMed
What do FAERS reports show?
11,139 reports list amiodarone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,934 are coded as a death and 5,523 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Amiodarone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions