Metoclopramide hydrochloride: adverse event reports filed with FDA

4,550

reports as suspect product

0% of all reports · about 202 a year

112

reports, 12 months to June 2026

141 in the 12 months before

86.4%

marked serious by the reporter

91.9% across the class

9.1%

record death among outcomes, as reported

416 reports · not verified by FDA

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 hydrochloride reports recording the termmedian drug in dopamine-2 receptor antagonist

1. Tardive dyskinesiainvoluntary repetitive movements55.1%2,505
2. Extrapyramidal disordermovement problems such as stiffness or tremor25.6%1,166
3. Incorrect drug administration duration15.6%708
4. Nervous system disorder9.7%442
5. Dystoniainvoluntary muscle contractions8%365
6. Tremorshaking7.2%329
7. Dyskinesiainvoluntary movements6.9%313
8. Movement disorder6.3%285
9. Off label useused for a purpose or in a way not on the label5.8%263
10. Drug ineffectivethe medicine did not work as expected5.3%240
11. Akathisiainner restlessness and an urge to move5.1%232
12. Nauseafeeling sick5%229
13. Drug hypersensitivityan allergic-type reaction to a medicine4.9%224
14. Product use in unapproved indicationused for a purpose not on the label4.1%188
15. Condition aggravatedthe condition being treated got worse4%183
16. Restless legs syndrome4%183
17. Parkinsonism3.5%161
18. Diarrhoealoose or frequent stools3.1%140
19. Depressionlow mood2.9%134
20. Painpain, site not specified2.9%134
21. Headachehead pain2.8%127
22. Dyspnoeashortness of breath2.8%126
23. Drug ineffective for unapproved indication2.7%123
24. Astheniaweakness or lack of energy2.7%121
25. Neuropathy peripheralnerve damage in hands or feet2.6%120
26. Suicidal ideationthoughts of suicide2.5%115
27. Anxietyanxiety2.4%108
28. Drug interactionan interaction between medicines2.4%108
29. Vomitingbeing sick2.3%103
30. Economic problema financial problem2.2%100

Top 30 of 741 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

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

The indication field is filled in by the reporter and is often blank; shares are of all 4,550 reports.

Drugs most often listed in the same reports

Other products listed in reports where Metoclopramide hydrochloride 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

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

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.

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 hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (5,437) 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.