This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1) ] . Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1) ] . Discontinue metoclopramide in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped [see Warnings and Precautions (5.1) ] . Avoid treatment with metoclopramide for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Warnings and Precautions (5.1) and Dosage and Administration (2.2 , 2.3) ]. WARNING: TARDIVE DYSKINESIA See full prescribing information for complete boxed warning . Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treat...
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
Metoclopramide is indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Metoclopramide is indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. ( 1 ) Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use : Metoclopramide is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. ( 1 , 8.4 ) Limitations of Use : Metoclopramide is not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations (8.4) ].
Metoclopramide is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide [see Warnings and Precautions (5.1 , 5.2) ] . When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation). In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor . Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor [see Warnings and Precautions (5.5) ] . In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures [see Adverse Reactions (6) ] . In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm [see Adverse Reactions (6) ] . History of TD or dystonic reaction to metoclopramide ( 4 ) When stimulation of gastrointestinal motility might be dangerous ( 4 ) Pheochromocytoma, catecholamine-releasing paragangliomas ( 4 ) Epilepsy ( 4 ) Hyp...
Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS) : Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson's Disease. If symptoms occur, discontinue metoclopramide and seek immediate medical attention. ( 5.1 , 5.2 , 5.3 , 7.1 , 7.2 ) Depression and suicidal ideation/suicide : Avoid use. ( 5.4 ) 5.1 Tardive Dyskinesia Metoclopramide can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. Movements may be choreoathetotic in appearance. The risk of developing TD and the likelihood that TD will become irreversible increases with duration of treatment and total cumulative dosage. Additionally, the risk of developing TD is increased among the elderly, especially elderly women [see Use in Specific Populations (8.5) ] , and in patients with diabetes mellitus. Due to the risk of developing TD, avoid treatment with metoclopramide for longer than 12 weeks and reduce the dosage in elderly patients [see Dosage and Administration (2.2 , 2.3) ]. Discontinue metoclopramide ...
The following adverse reactions are described, or described in greater detail, in other sections of the labeling: Tardive dyskinesia [see Boxed Warning and Warnings and Precautions (5.1) ] Other extrapyramidal effects [see Warnings and Precautions (5.2) ] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3) ] Depression [see Warnings and Precautions (5.4) ] Hypertension [see Warnings and Precautions (5.5) ] Fluid retention [see Warnings and Precautions (5.6) ] Hyperprolactinemia [see Warnings and Precautions (5.7) ] Effects on the ability to drive and operate machinery [see Warnings and Precautions (5.8) ] The following adverse reactions have been identified from clinical studies or postmarketing reports of metoclopramide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions (in approximately 10% of patients receiving 10 mg of metoclopramide four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage an...
Boxed Warning 8/2017 Indications and Usage ( 1 ) 8/2017 Dosage and Administration, Dosage for Gastroesophageal Reflux ( 2.2 ) 8/2017 Dosage and Administration, Dosage for Acute and Recurrent Diabetic Gastroparesis ( 2.3 ) 8/2017 Contraindications ( 4 ) 8/2017 Warnings and Precautions, Tardive Dyskinesia ( 5.1 ) 8/2017 Warnings and Precautions, Other Extrapyramidal Symptoms ( 5.2 ) 8/2017 Warnings and Precautions, Neuroleptic Malignant Syndrome ( 5.3 ) 8/2017 Warnings and Precautions, Hyperprolactinemia ( 5.7 ) 8/2017
Source: FDA SPL label for Metoclopramide (PAI Holdings, LLC dba PAI Pharma), effective 20241113. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 5,831 | 5,553 | 5,427 | 5,000 | 4,491 | 4,193 | 3,758 | 1,839 |
8,826 reports blaming this drug for every million Medicare prescriptions filled, which is 3.2× the typical drug on this site. (9,666 reports in 2024–2026, against 1,095,227 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 10/2026 | Class II | American Health Packaging | Presence of Foreign Tablets/Capsules |
| 09/2026 | Class II | Teva Pharmaceuticals USA, Inc | Presence of Foreign Tablets/Capsules |
| 05/2025 | Class II | Teva Pharmaceuticals USA, Inc | Presence of foreign tablets/capsules. |
| 07/2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
| 04/2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
| 02/2021 | Class II | Teva Pharmaceuticals USA | Chemical contamination; Unknown brown residue adhering to the inside of one vial. |
| 02/2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. |
| 09/2013 | Class II | Hospira Inc. | Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $269,748 in payments to US physicians and hospitals tied to this drug across 3,368 transactions (Gimoti $269,748).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Metoclopramide HCl | 1,092,954 | $8 |
| Gimoti | 2,151 | $2,116 |
| Reglan | 122 | $555 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.