Drug side effects
metoclopramide Side Effects
The reactions most often reported to the FDA for metoclopramide (also sold as Reglan), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 53,266
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 1995 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of metoclopramide come from 53,266 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 53,266 reports to the FDA Adverse Event Reporting System (FAERS) for metoclopramide (Reglan): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
53,266
Reports Mentioning Death
7,091
13.3% of reports — not proof the medicine caused the death
Hospitalizations
24,739
46.4% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 7,091 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 1,232 |
| PNEUMONIA | 547 |
| TARDIVE DYSKINESIA | 521 |
| VOMITING | 514 |
| NAUSEA | 512 |
| DIARRHOEA | 443 |
| NERVOUS SYSTEM DISORDER | 407 |
| DYSPNOEA | 406 |
| SEPSIS | 338 |
| TOXICITY TO VARIOUS AGENTS | 327 |
| MALIGNANT NEOPLASM PROGRESSION | 309 |
| EXTRAPYRAMIDAL DISORDER | 308 |
| DISEASE PROGRESSION | 306 |
| ACUTE KIDNEY INJURY | 303 |
| PYREXIA | 292 |
| ANAEMIA | 286 |
| CARDIAC ARREST | 282 |
| FATIGUE | 280 |
| RENAL FAILURE | 271 |
Reactions in Hospitalization Reports
Top reactions in 24,739 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| TARDIVE DYSKINESIA | 2,773 |
| EXTRAPYRAMIDAL DISORDER | 2,756 |
| NERVOUS SYSTEM DISORDER | 2,542 |
| NAUSEA | 2,501 |
| VOMITING | 2,203 |
| DYSTONIA | 1,979 |
| DIARRHOEA | 1,868 |
| FEBRILE NEUTROPENIA | 1,745 |
| PYREXIA | 1,738 |
| DYSPNOEA | 1,421 |
| PNEUMONIA | 1,263 |
| PAIN | 1,176 |
| FATIGUE | 1,164 |
| ABDOMINAL PAIN | 1,106 |
| ANAEMIA | 996 |
| CONSTIPATION | 965 |
| ACUTE KIDNEY INJURY | 918 |
| DEHYDRATION | 917 |
| ASTHENIA | 883 |
Nearby, Related Medications
What the FAERS Data Reveals About metoclopramide Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 53,266 voluntary reports linked to metoclopramide and its brand equivalents (Reglan), spanning 1995 through 2025. Of those, 7,091 (13.3%) listed death as an outcome and 24,739 (46.4%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 60% were female and 37% male; age distribution skews toward 45-64, with 11,124 reports in that bracket. The single most reported reaction is tardive dyskinesia with 13,205 submissions, followed by extrapyramidal disorder and nervous system disorder.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to metoclopramide's 53,266.
Read our methodology - how this data is sourced, computed, and verified.