Reglan: adverse event reports filed with FDA

8,138

reports as suspect product

0% of all reports · about 362 a year

40

reports, 12 months to June 2026

39 in the 12 months before

85.5%

marked serious by the reporter

91.9% across the class

2.4%

record death among outcomes, as reported

196 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 Reglan reports recording the termmedian drug in dopamine-2 receptor antagonist

1. Tardive dyskinesiainvoluntary repetitive movements69.8%5,684
2. Extrapyramidal disordermovement problems such as stiffness or tremor39.9%3,249
3. Dystoniainvoluntary muscle contractions28.7%2,336
4. Dyskinesiainvoluntary movements9%735
5. Incorrect drug administration duration8.6%698
6. Drug hypersensitivityan allergic-type reaction to a medicine6.9%563
7. Akathisiainner restlessness and an urge to move6.7%548
8. Tremorshaking6.5%529
9. Nervous system disorder4.2%342
10. Movement disorder3.6%295
11. Visual impairmentreduced vision3.5%282
12. Restless legs syndrome3.2%258
13. Drug interactionan interaction between medicines3.1%256
14. Depression suicidal2.7%223
15. Anxietyanxiety2.6%210
16. Condition aggravatedthe condition being treated got worse2.4%197
17. Unevaluable eventthe event could not be assessed2.4%193
18. Hypersensitivityan allergic-type reaction2.2%180
19. Depressionlow mood2.1%169
20. Parkinsonism2%160
21. Nauseafeeling sick1.9%157
22. Astheniaweakness or lack of energy1.8%143
23. Neuropathy peripheralnerve damage in hands or feet1.7%135
24. Economic problema financial problem1.6%127
25. Vomitingbeing sick1.5%125
26. Painpain, site not specified1.4%111
27. Suicidal ideationthoughts of suicide1.3%107
28. Dyspnoeashortness of breath1.3%105
29. Activities of daily living impaired1.1%93
30. Parkinson's diseaseParkinson's disease1.1%93

Top 30 of 481 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. 97.9% 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 8,138 reports.

Drugs most often listed in the same reports

Other products listed in reports where Reglan 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 Reglan as a suspect or interacting product; reports listing it only as a concomitant medication (11,396) 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.