What the label lists and what reports show
Atracurium side effects
Atracurium's FDA label: “The following adverse reactions are among the most frequently reported, but there are insufficient data to support an estimate of their incidence: General: Allergic reactions (anaphylactic or anaphylactoid responses) which, in rare instances, were severe …” FAERS holds 703 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 hypotension (74 reports).
- Generic listed
Check it at the source: the atracurium FDA label on DailyMed (effective December 4, 2024, Meitheal Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following adverse reactions are among the most frequently reported, but there are insufficient data to support an estimate of their incidence: General: Allergic reactions (anaphylactic or anaphylactoid responses) which, in rare instances, were severe (e.g., cardiac arrest) Musculoskeletal: Inadequate block, prolonged block Cardiovascular: Hypotension, vasodilatation (flushing) […]
Table 1: Percent of Patients Reporting Adverse Reactions
| Reaction | 0.00-0.30 (n = 485) | 0.31-0.50* (n = 366) | ≥0.60 (n = 24) | Total (n = 875) |
|---|---|---|---|---|
| Skin Flush | 1.0% | 8.7% | 29.2% | 5.0% |
| Erythema | 0.6% | 0.5% | 0% | 0.6% |
| Itching | 0.4% | 0% | 0% | 0.2% |
| Wheezing/Bronchial Secretions | 0.2% | 0.3% | 0% | 0.2% |
| Hives | 0.2% | 0% | 0% | 0.1% |
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, continuedObserved in Controlled Clinical Studies Atracurium was well tolerated and produced few adverse reactions during extensive clinical trials. Most adverse reactions were suggestive of histamine release. In studies including 875 patients, atracurium was discontinued in only one patient (who required treatment for bronchial secretions) and six other patients required treatment for adverse reactions attributable to atracurium (wheezing in one, hypotension in five). Of the five patients who required treatment for hypotension, three had a history of significant cardiovascular disease. The overall incidence rate for clinically important adverse reactions, therefore, was 7/875 or 0.8%. Table 1 includes all adverse reactions reported attributable to atracurium during clinical trials with 875 patients. Table 1: Percent of Patients Reporting Adverse Reactions * Includes the recommended initial dosage range for most patients. Adverse Reaction Initial Atracurium Dose (mg/kg) 0.00-0.30 (n = 485) 0.31-0.50* (n = 366) ≥0.60 (n = 24) Total (n = 875) Skin Flush 1.0% 8.7% 29.2% 5.0% Erythema 0.6% 0.5% 0% 0.6% Itching 0.4% 0% 0% 0.2% Wheezing/Bronchial Secretions 0.2% 0.3% 0% 0.2% Hives 0.2% 0% 0% 0.1% Most adverse reactions were of little clinical significance unless they were associated with significant hemodynamic changes. …
Source: FDA drug label, Meitheal Pharmaceuticals Inc., effective December 4, 2024 (SPL set efe90ee2-fe9e-421f-9e54-2961085d3b12), via openFDA; the full label on DailyMed
What do FAERS reports show?
703 reports list atracurium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 94 are coded as a death and 254 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 21 reactions below, 7 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?
- Atracurium: 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