Drugs › Dopamine-2 receptor antagonist
Generic name
Droperidol: adverse event reports filed with FDA
990 reports list it as a suspect or interacting product, 2004–2026. Class: Dopamine-2 receptor antagonist. Also reported as Droperidol Injection, Droperidol Injection Usp.
- 990
- reports as suspect product
- 0% of all reports · about 44 a year
- 111
- reports, 12 months to June 2026
- 97 in the 12 months before
- 91%
- marked serious by the reporter
- 91.9% across the class
- 9.1%
- record death among outcomes, as reported
- 90 reports · not verified by FDA
Between March 2004 and June 2026, 990 adverse event reports received by FDA list droperidol, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (631) are left out of every figure here.
In the 12 months to June 2026, 111 reports listed it, up 14% from 97 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 44 reports a year and 0% of the 20,646,523 reports in the database, and 2.5% of the reports for the dopamine-2 receptor antagonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded anaphylactic shock (7.8%), drug interaction (5.5%) and hypotension (5.3%). A report can list several reactions, so shares add to more than 100%; 285 different terms appear across these reports. Anaphylactic shock is recorded in 7.8% of these reports, with no counterpart in the median dopamine-2 receptor antagonist drug (0%).
91% of the reports are marked serious by the reporter (91.9% across the class); 9.1% record death among the outcomes and 38.7% record hospitalisation, as reported. 47.3% of the reports came from physicians, and the largest patient age group is 18 to 44 (31.9%). 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 Droperidol reports recording the termmedian drug in dopamine-2 receptor antagonist
- Anaphylactic shocka severe allergic reaction with collapse7.8%77
- Drug interactionan interaction between medicines5.5%54
- Hypotensionlow blood pressure5.3%52
- Anaphylactic reactiona severe, sudden allergic reaction4.8%48
- Drug hypersensitivityan allergic-type reaction to a medicine4.5%45
- Tachycardiafast heart rate3.7%37
- Cardiac arrestthe heart stopped3.3%33
- Vomitingbeing sick3.2%32
- Restlessnessrestlessness3%30
- Off label useused for a purpose or in a way not on the label2.7%27
- Cardio-respiratory arrestthe heart and breathing stopped2.6%26
- Agitationrestlessness2.5%25
- Drug ineffectivethe medicine did not work as expected2.5%25
- Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement2.5%25
- Nauseafeeling sick2.5%25
- Renal failure acute2.5%25
- Anxietyanxiety2.4%24
- Dyspnoeashortness of breath2.4%24
- Electrocardiogram QT prolongeda QT prolongation on the ECG2.4%24
- Rashskin rash2.4%24
- Dizzinesslight-headedness or unsteadiness2.3%23
- Acute kidney injurysudden loss of kidney function2.1%21
- Akathisiainner restlessness and an urge to move2.1%21
- Lactic acidosisa build-up of lactic acid in the blood2%20
- Oliguria2%20
- Haematuriablood in the urine1.9%19
- Feeling abnormalfeeling odd or not right1.8%18
- Hypoaesthesianumbness1.8%18
- Bradycardiaslow heart rate1.7%17
- Confusional stateconfusion1.5%15
Top 30 of 285 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 6 drugs in the dopamine-2 receptor antagonist 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 40,014 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. 31.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Prophylaxis of nausea and vomiting | 143 | 14.4% |
| Nausea | 67 | 6.8% |
| General anaesthesia | 49 | 4.9% |
| Anaesthesia | 47 | 4.7% |
| Induction of anaesthesia | 31 | 3.1% |
| Agitation | 27 | 2.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 990 reports.
In context
| Measure | Droperidol | Dopamine-2 receptor antagonist | All reports |
|---|---|---|---|
| Reports as suspect product | 990 | 40,014 | 20,646,523 |
| Share of that pool | — | 2.5% | 0% |
| Reports, latest 12 months | 111 | — | 1,332,454 |
| Marked serious | 91% | 91.9% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 91 | 71 | 91 |
| Hospitalisation recorded, per 1,000 reports | 387 | 236 | 213 |
| Consumer-filed share | 12.2% | 10.5% | 45.8% |
| Top term, share of reports | Anaphylactic shock 7.8% | median 0% | 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 dopamine-2 receptor antagonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Metoclopramide | generic | 22,305 | 595 | 96.4% |
| Reglan | brand | 8,138 | 40 | 85.5% |
| Metoclopramide hydrochloride | generic | 4,550 | 112 | 86.4% |
| Amisulpride | generic | 3,503 | 295 | 98.4% |
| Gimoti | brand | 528 | 81 | 5.5% |
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 Droperidol reports
How many adverse event reports has FDA received for Droperidol?
990 reports list Droperidol as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 111 of them arrived in the latest 12 months. Another 631 list it only as a concomitant medication.
What reactions are recorded in Droperidol reports?
anaphylactic shock (7.8%), drug interaction (5.5%), hypotension (5.3%), anaphylactic reaction (4.8%) and drug hypersensitivity (4.5%). 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 Droperidol was responsible.
How serious are the reports?
91% are marked serious by the reporter. Among the outcomes recorded, 9.1% of reports include death and 38.7% 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 (47.3%), other health professional (27.4%) and consumer or non-health professional (12.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Droperidol rising?
111 reports in the 12 months to June 2026, up 14% from 97 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 Droperidol 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 Droperidol?
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 Droperidol as a suspect or interacting product; reports listing it only as a concomitant medication (631) 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.