Drugs › Dopamine-2 receptor antagonist
Generic name
Metoclopramide: adverse event reports filed with FDA
22,305 reports list it as a suspect or interacting product, 2004–2026. Class: Dopamine-2 receptor antagonist. Also reported as Metoclopramide Injection, Metoclopramide Tablets Usp, Metoclopramide Tablet.
- 22,305
- reports as suspect product
- 0.1% of all reports · about 992 a year
- 595
- reports, 12 months to June 2026
- 610 in the 12 months before
- 96.4%
- marked serious by the reporter
- 91.9% across the class
- 7.8%
- record death among outcomes, as reported
- 1,742 reports · not verified by FDA
22,305 adverse event reports received by FDA list metoclopramide, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 32,800 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, 595 reports listed it, close to the 610 of 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 992 reports a year and 0.1% of the 20,646,523 reports in the database, and 55.7% 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 tardive dyskinesia (59.2%), extrapyramidal disorder (52.1%) and nervous system disorder (31.8%). A report can list several reactions, so shares add to more than 100%; 1,810 different terms appear across these reports. Tardive dyskinesia is recorded in 59.2% of these reports, a larger share than in the median dopamine-2 receptor antagonist drug (28.3%).
96.4% of the reports are marked serious by the reporter (91.9% across the class); 7.8% record death among the outcomes and 27% record hospitalisation, as reported. 61.3% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (10%). 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 Metoclopramide reports recording the termmedian drug in dopamine-2 receptor antagonist
- Tardive dyskinesiainvoluntary repetitive movements59.2%13,203
- Extrapyramidal disordermovement problems such as stiffness or tremor52.1%11,631
- Nervous system disorder31.8%7,093
- Dystoniainvoluntary muscle contractions29.9%6,669
- Economic problema financial problem16.5%3,673
- Painpain, site not specified15.9%3,549
- Movement disorder12.7%2,834
- Activities of daily living impaired12.2%2,731
- Anxietyanxiety11.8%2,621
- Dyskinesiainvoluntary movements11.2%2,498
- Incorrect drug administration duration11.1%2,476
- Deformity10.4%2,309
- Multiple injuries9.4%2,098
- Quality of life decreasedreduced quality of life8.9%1,992
- Family stress8.6%1,909
- Tremorshaking7.7%1,723
- Emotional distressemotional distress7.6%1,689
- Fear7.3%1,630
- Akathisiainner restlessness and an urge to move7.2%1,610
- Anhedonia6.8%1,521
- Unevaluable eventthe event could not be assessed4.8%1,061
- Emotional disorder4.5%1,000
- Nauseafeeling sick4%902
- Mental disorder4%900
- Drug interactionan interaction between medicines4%887
- Drug ineffectivethe medicine did not work as expected3.6%792
- Injurya physical injury3.4%752
- Off label useused for a purpose or in a way not on the label3.4%751
- Astheniaweakness or lack of energy3%663
- Visual impairmentreduced vision2.8%625
Top 30 of 1,810 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. 72.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Abdominal distension | 1,845 | 8.3% |
| Dyspepsia | 1,371 | 6.1% |
| Nausea | 1,204 | 5.4% |
| Gastrointestinal disorder | 640 | 2.9% |
| Vomiting | 439 | 2% |
| Gastrooesophageal reflux disease | 387 | 1.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 22,305 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Metoclopramide reports |
|---|---|---|
| Reglan | 3,575 | 16% |
| Ondansetron | 1,472 | 6.6% |
| Acetaminophen | 1,286 | 5.8% |
| Dexamethasone | 1,034 | 4.6% |
| Omeprazole | 874 | 3.9% |
| Furosemide | 748 | 3.4% |
| Pantoprazole | 655 | 2.9% |
| Lansoprazole | 538 | 2.4% |
| Diazepam | 476 | 2.1% |
| Albuterol | 466 | 2.1% |
Other products listed in reports where Metoclopramide is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Metoclopramide | Dopamine-2 receptor antagonist | All reports |
|---|---|---|---|
| Reports as suspect product | 22,305 | 40,014 | 20,646,523 |
| Share of that pool | — | 55.7% | 0.1% |
| Reports, latest 12 months | 595 | — | 1,332,454 |
| Marked serious | 96.4% | 91.9% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 78 | 71 | 91 |
| Hospitalisation recorded, per 1,000 reports | 270 | 236 | 213 |
| Consumer-filed share | 7.5% | 10.5% | 45.8% |
| Top term, share of reports | Tardive dyskinesia 59.2% | median 28.3% | 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 dopamine-2 receptor antagonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Reglan | brand | 8,138 | 40 | 85.5% |
| Metoclopramide hydrochloride | generic | 4,550 | 112 | 86.4% |
| Amisulpride | generic | 3,503 | 295 | 98.4% |
| Droperidol | generic | 990 | 111 | 91% |
| 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 Metoclopramide reports
How many adverse event reports has FDA received for Metoclopramide?
22,305 reports list Metoclopramide as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 595 of them arrived in the latest 12 months. Another 32,800 list it only as a concomitant medication.
What reactions are recorded in Metoclopramide reports?
tardive dyskinesia (59.2%), extrapyramidal disorder (52.1%), nervous system disorder (31.8%), dystonia (29.9%) and economic problem (16.5%). 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 Metoclopramide was responsible.
How serious are the reports?
96.4% are marked serious by the reporter. Among the outcomes recorded, 7.8% of reports include death and 27% 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?
lawyer (61.3%), other health professional (15.1%) and physician (9.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Metoclopramide rising?
595 reports in the 12 months to June 2026, close to the 610 of 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 Metoclopramide 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 Metoclopramide?
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 Metoclopramide as a suspect or interacting product; reports listing it only as a concomitant medication (32,800) 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.