Drugs › Nondepolarizing neuromuscular blocker
Generic name
Atracurium besylate: adverse event reports filed with FDA
511 reports list it as a suspect or interacting product, 2004–2026. Class: Nondepolarizing neuromuscular blocker. Also reported as Atracurium Besylate Injection Usp.
- 511
- reports as suspect product
- 0% of all reports · about 23 a year
- 42
- reports, 12 months to June 2026
- 34 in the 12 months before
- 96.9%
- marked serious by the reporter
- 90% across the class
- 11.7%
- record death among outcomes, as reported
- 60 reports · not verified by FDA
511 adverse event reports received by FDA list atracurium besylate, a generic name as a suspect or interacting product, from March 2004 to June 2026. A further 186 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 42 reports listed it, up 24% from 34 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 23 reports a year and 0% of the 20,646,523 reports in the database, and 5.4% of the reports for the nondepolarizing neuromuscular blocker class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are anaphylactic shock (12.1%), hypotension (11.4%) and anaphylactic reaction (10.2%). A report can list several reactions, so shares add to more than 100%; 216 different terms appear across these reports. Anaphylactic shock is recorded in 12.1% of these reports, a larger share than in the median nondepolarizing neuromuscular blocker drug (9.3%).
96.9% of the reports are marked serious by the reporter (90% across the class); 11.7% record death among the outcomes and 32.7% record hospitalisation, as reported. 42.5% of the reports came from physicians, and the largest patient age group is 45 to 64 (28%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Atracurium besylate reports recording the termmedian drug in nondepolarizing neuromuscular blocker
- Anaphylactic shocka severe allergic reaction with collapse12.1%62
- Hypotensionlow blood pressure11.4%58
- Anaphylactic reactiona severe, sudden allergic reaction10.2%52
- Bronchospasmtightening of the airways6.1%31
- Bradycardiaslow heart rate5.7%29
- Thrombocytopenialow platelets3.7%19
- Cardiac arrestthe heart stopped3.5%18
- Condition aggravatedthe condition being treated got worse3.1%16
- Eosinophilia3.1%16
- Hepatic cytolysis3.1%16
- Leukocytosis3.1%16
- Rash maculo-papulara rash of flat and raised spots3.1%16
- Hyperglycaemiahigh blood sugar2.7%14
- Circulatory collapsecollapse of the circulation2.3%12
- Respiratory failurethe lungs could not supply enough oxygen2.3%12
- Wrong drug administeredthe wrong medicine was given2.3%12
- Drug ineffectivethe medicine did not work as expected2.2%11
- Rashskin rash2.2%11
- Cyanosis2%10
- Off label useused for a purpose or in a way not on the label2%10
- Paralysis flaccid2%10
- Respiratory arrestbreathing stopped2%10
- Tachycardiafast heart rate2%10
- Ventricular fibrillationa chaotic rhythm from the lower heart chambers1.8%9
- Cyanosis neonatal1.6%8
- Dystoniainvoluntary muscle contractions1.6%8
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine1.6%8
- Anaesthetic complication1.4%7
Top 30 of 216 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the nondepolarizing neuromuscular blocker class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 9,444 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 4.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| General anaesthesia | 71 | 13.9% |
| Anaesthesia | 70 | 13.7% |
| Induction of anaesthesia | 36 | 7% |
| Neuromuscular blocking therapy | 19 | 3.7% |
| Acute myeloid leukaemia | 11 | 2.2% |
| Muscle relaxant therapy | 11 | 2.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 511 reports.
In context
| Measure | Atracurium besylate | Nondepolarizing neuromuscular blocker | All reports |
|---|---|---|---|
| Reports as suspect product | 511 | 9,444 | 20,646,523 |
| Share of that pool | — | 5.4% | 0% |
| Reports, latest 12 months | 42 | — | 1,332,454 |
| Marked serious | 96.9% | 90% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 117 | 69 | 91 |
| Hospitalisation recorded, per 1,000 reports | 327 | 302 | 213 |
| Consumer-filed share | 3.1% | 5.4% | 45.8% |
| Top term, share of reports | Anaphylactic shock 12.1% | median 9.3% | 0.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the nondepolarizing neuromuscular blocker class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Rocuronium bromide | generic | 4,046 | 517 | 83% |
| Rocuronium | generic | 3,358 | 628 | 96.2% |
| Cisatracurium | brand | 786 | 53 | 98.5% |
| Vecuronium bromide | generic | 743 | 31 | 86.9% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Atracurium besylate reports
How many adverse event reports has FDA received for Atracurium besylate?
511 reports list Atracurium besylate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 42 of them arrived in the latest 12 months. Another 186 list it only as a concomitant medication.
What reactions are recorded in Atracurium besylate reports?
anaphylactic shock (12.1%), hypotension (11.4%), anaphylactic reaction (10.2%), bronchospasm (6.1%) and bradycardia (5.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Atracurium besylate was responsible.
How serious are the reports?
96.9% are marked serious by the reporter. Among the outcomes recorded, 11.7% of reports include death and 32.7% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (42.5%), other health professional (37%) and not given (10.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Atracurium besylate rising?
42 reports in the 12 months to June 2026, up 24% from 34 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Atracurium besylate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Atracurium besylate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Atracurium besylate as a suspect or interacting product; reports listing it only as a concomitant medication (186) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.