REGLAN FDA MedWatch Direct Reports Summary

These tables and charts are created from 568 voluntary U.S. reports for REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS REGLAN Report.

Top Adverse Effects Associated with REGLAN (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	NAUSEA	49
2	VOMITING	42
3	DEATH	41
4	ANXIETY	35
5	FATIGUE	31
6	DIZZINESS	28
7	TREMOR	28
8	SHORTNESS OF BREATH	27
9	DIARRHEA	26
10	FEELING ABNORMAL	23
11	INSOMNIA	23
12	PAIN	22
13	DISEASE PROGRESSION	20
14	HOSPITALIZATION	19
15	DEPRESSION	18
16	HEADACHE	18
17	DRUG INEFFECTIVE	17
18	HEART RATE INCREASED	17
19	SUICIDAL IDEATION	17
20	LACK OF STRENGTH AND ENERGY (ASTHENIA)	16
21	MUSCLE SPASMS	16
22	CHEST PAIN	15
23	FEVER	15
24	THERAPY CESSATION	15
25	DYSKINESIA	13

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REGLAN Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
143	407	18	568

Medwatch Reporter Type	Count
Consumer	194
Physician	32
Pharmacist	107
Other Health Professional	101

Top Indications

Nausea
Impaired gastric emptying

Type of Outcome Reported
Serious: 421
Not Serious: 147
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 568
Concomitant Drugs: 467
Note: A single MedWatch report can list more than one drug. This summary includes REGLAN identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) Rx Drug:
FDA Safety-related Labeling Changes

Use for shortest time possible to reduce risk of tardive dyskinesia. Metoclopramide, including Reglan, may also suppress, or partially suppress, the signs of TD, and may delay the diagnosis of TD.

Have experience (good or bad) with REGLAN? Rate REGLAN at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.