Drug Safety Information for REGLAN (Metoclopramide hydrochloride)

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

Safety-related Labeling Changes for METOZOLV ODT (METOCLOPRAMIDE HYDROCHLORIDE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for GIMOTI (METOCLOPRAMIDE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for REGLAN* (Metoclopramide hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with REGLAN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Tardive dyskinesia16280
2Extrapyramidal disorder12901
3Nervous system disorder7591
4Dystonia6897
5Pain4782
6Economic problem4088
7Incorrect drug administration duration3770
8Anxiety*3479
9Movement disorder3311
10Dyskinesia3171
11Activities of daily living impaired3051
12Nausea2868
13Deformity2523
14Vomiting2458
15Multiple injuries2349
16Tremor*2335
17Quality of life decreased2072
18Emotional distress1965
19Family stress1952
20Akathisia1824

* This side effect also appears in "Top 10 Side Effects of REGLAN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking REGLAN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Abdominal distension34816
2Product used for unknown indication28552
3Nausea*13137
4Gastrooesophageal reflux disease*10787
5Gastrointestinal disorder5993
6Vomiting*2417
7Impaired gastric emptying*2322
8Gastric disorder2091
9Prophylaxis1488
10Prophylaxis of nausea and vomiting1399

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for REGLAN

Total Reports Filed with FDA: 265058


Number of FDA Adverse Event Reports by Patient Age for REGLAN

Total Reports Filed with FDA: 265058*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Metoclopramide hydrochloride (Clopra-"yellow", Metoclopramida, Reglan odt, Metozolv, Clopra, Metaclopramide, Primperan, "clopra-""yellow""", Metoclopramide, Cerucal, Metroclopramide, Mcp, Metaclopromide, Metozolv odt, Reglan, Maxolon)

Charts are based on 265058 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and REGLAN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.