Prescription medicine
Metoclopramide Brand names: Reglan, Gimoti
Metoclopramide (Reglan) is a prescription medicine with an FDA approval on record since 1979. FDA's NDC Directory lists it from 39 generic labelers, and pharmacies paid $0.0439 per metoclopramide 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the metoclopramide FDA label on DailyMed (effective May 18, 2026, ANI Pharmaceuticals, Inc.); the NDA 17862 record on Drugs@FDA; every metoclopramide label on DailyMed.
Highlights of the record
FDA label of May 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
TARDIVE DYSKINESIA •.
Metoclopramide, including metoclopramide tablets, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including metoclopramide tablets, the risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions ( 5.1 )].
Metoclopramide tablets are contraindicated in patients with a history of TD.
Use metoclopramide tablets for the shortest duration of treatment and periodically reassess the need for continued treatment.
Immediately discontinue metoclopramide tablets in patients who develop signs or symptoms of TD [see Warnings and Precautions ( 5.1 )].
In patients with symptomatic, documented gastroesophageal reflux, the maximum duration of metoclopramide tablets treatment is 12 weeks [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 )].
In patients with diabetic gastroparesis, avoid a total duration of treatment with metoclopramide products, including metoclopramide tablets, for longer than 12 weeks. If longer term use is unavoidable, routinely monitor for signs and symptoms of TD [see Warnings and Precautions ( 5.1 )]. WARNING: TARDIVE DYSKINESIA See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageMetoclopramide Tablets USP are indicated for the:
Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy.
Forms and strengths
- 5 mg
- 10 mg
- 5 mg/ml
- 5 mg/5ml
- 10 mg/2ml
- 15 mg/.07ml
Tablet; injection (solution); solution; injection; orally disintegrating tablet.
On the market
- Earliest approval on file
- February 7, 1979 Reglan, Hikma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 42 first July 29, 1985; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 40 of which 39 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- November 17, 2038 Gimoti spray; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0439 per tablet Metoclopramide 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 10 since 2011 0 Class I among all firms' recalls; latest May 23, 2025; 2 more by firms not listed as its makers
- FAERS reports
- 76,710 through July 30, 2026
What is metoclopramide used for?
From the label: indications and usageMetoclopramide Tablets USP are 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. Limitations of Use:
Metoclopramide Tablets USP have not been shown to be safe and effective for the treatment of symptomatic, documented gastroesophageal reflux for longer than 12 weeks [see Warnings and Precautions ( 5.1 )]. […]
Conditions named in the indications of metoclopramide's FDA labels, with every medicine labeled for each:
From other metoclopramide labelsAcid reflux and ulcers: Treatment of symptomatic, documented gastroesophageal reflux disease (GERD) in adults with who fail to respond to conventional therapy.
Nausea and vomiting: Significant relief of nausea occurs early and continues to improve over a three-week period.
FDA pharmacologic class: Dopamine-2 Receptor Antagonist.
Source: FDA drug label (Metoclopramide), NDA017854 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective May 18, 2026 (SPL set 797aad80-0597-42f8-99d5-39de180c3b5a), via openFDA; the full label on DailyMed
What does the patient leaflet for metoclopramide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about metoclopramide tablets?Metoclopramide tablets can cause a potentially irreversible serious side effect called tardive dyskinesia (abnormal muscle movements). • These movements happen mostly in the face or tongue, and sometimes in other body parts. You cannot control these movements. • These symptoms may not go away even after stopping metoclopramide tablets. Your chances of getting tardive dyskinesia increase: • the longer you take metoclopramide tablets and the more metoclopramide tablets you take. • Use the lowest dose possible for the shortest time needed. • People taking metoclopramide tablets to relieve heartburn symptoms with gastroesophageal reflux should not take metoclopramide tablets for more than 12 weeks. • People taking metoclopramide tablets to relieve symptoms of slow stomach emptying due to diabetes, should not take metoclopramide tablets for more than 12 weeks. If you require treatment for longer than 12 weeks, your healthcare provider should frequently monitor you for signs and symptoms of tardive dyskinesia. • if you are older, especially if you are an older woman. • if you have diabetes. It is not possible for your healthcare provider to know if you will get tardive dyskinesia if you take metoclopramide tablets. Stop taking metoclopramide tablets and call your healthcare provider right away if you get movements you cannot stop or control, such as: • lip smacking, chewing, or puckering up your mouth • frowning or scowling • sticking out your tongue • blinking and moving your eyes • shaking of your arms and legs Your healthcare provider may decide not to continue treatment with metoclopramide tablets if you develop signs or symptoms of tardive dyskinesia. See the section "What are the possible side effects of metoclopramide tablets?" for more information about side effects.
From the patient leaflet: What should I avoid while taking metoclopramide tablets?Do not drink alcohol while taking metoclopramide tablets. Alcohol may make some side effects of metoclopramide tablets worse, such as feeling sleepy. • Do not drive, operate machinery, or do other dangerous activities until you know how metoclopramide tablets affect you. Metoclopramide tablets may cause sleepiness or dizziness.
From the patient leaflet: How should I store metoclopramide tablets?Store metoclopramide tablets at room temperature between 68°F to 77°F (20°C to 25°C). • Keep metoclopramide tablets in the bottle it comes in and away from light. Keep the bottle closed tightly. Keep metoclopramide tablets and all medicines out of the reach of children.
Source: FDA drug label (Metoclopramide), NDA017854 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective May 18, 2026 (SPL set 797aad80-0597-42f8-99d5-39de180c3b5a), via openFDA; the full label on DailyMed
Is there a generic for metoclopramide (Reglan)?
The FDA approved the first generic metoclopramide on July 29, 1985. 42 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists metoclopramide from 39 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Reglan tablets; a patent listed only for Gimoti spray runs to November 17, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1979 earliest approval on file
- 1985 first generic approved
- 2038 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for metoclopramide (Reglan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0439 per Metoclopramide 10 mg tablet, down 11% from $0.0494 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Metoclopramide 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Metoclopramide 10 mg tablet | Generic | $0.0439 per tablet | $1.32 | -11% |
| Metoclopramide 10 mg/2 mL vial | Generic | $0.529 per mL | $1.06 per vial | -7% |
| Metoclopramide 5 mg tablet | Generic | $0.0358 per tablet | $1.07 | -16% |
| Metoclopramide 5 mg/5 mL solution | Generic | $0.126 per mL | n/a | +14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has metoclopramide been recalled?
The FDA's Enforcement Report lists 12 recalls naming metoclopramide since 2011: 0 Class I (the most serious), 10 Class II, 2 Class III; 2 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of metoclopramide and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 23, 2025 | Class II | Teva Pharmaceuticals USA, Inc | Presence of foreign tablets/capsules. |
| July 29, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
| April 26, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
| February 15, 2021 | Class II | Teva Pharmaceuticals USA | Chemical contamination; Unknown brown residue adhering to the inside of one vial. |
| February 10, 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 … |
| January 18, 2017 | Class II | VistaPharm, Inc. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. |
| June 26, 2015 | Class III | VistaPharm, Inc. | Defective Container: Lids on unit dose cups are not fully qualified. |
| August 13, 2014 | Class II | VistaPharm, Inc. | Defective Container: Product leaks when inverted. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the metoclopramide label say about other medicines?
The metoclopramide label names 21 other medicines in its interaction, contraindication or warning sections. The labels of 43 other medicines name metoclopramide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Apomorphine | drug interactions | Examples; apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine |
| Atovaquone | drug interactions | … leading to decreased or increased drug exposure. Intervention Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oral suspension*, fosfomycin): Monitor for reduced therapeutic effect of the interacting drug. … |
| Benztropine | warnings and precautions | Diphenhydramine hydrochloride or benztropine mesylate may be used to treat these adverse reactions. |
| Bromocriptine | drug interactions | Examples; apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine |
| Bupropion | drug interactions | Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine): See Full Prescribing Information for recommended dosage reductions. |
| Cabergoline | drug interactions | Examples; apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine |
| Cyclosporine | drug interactions | … needed (see prescribing information for digoxin). Drugs with Increased Absorption (e.g., sirolimus, tacrolimus, cyclosporine): Monitor therapeutic drug concentrations and adjust the dose as needed. See prescribing information for the interacting drug. |
| Digoxin | drug interactions | … drugs leading to decreased or increased drug exposure. Intervention Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oral suspension*, fosfomycin): Monitor for reduced therapeutic effect of the interacting drug. … |
| Diphenhydramine | warnings and precautions | Diphenhydramine hydrochloride or benztropine mesylate may be used to treat these adverse reactions. |
| Fluoxetine | drug interactions | Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine): See Full Prescribing Information for recommended dosage reductions. |
| Fosfomycin | drug interactions | … exposure. Intervention Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oral suspension*, fosfomycin): Monitor for reduced therapeutic effect of the interacting drug. For digoxin monitor therapeutic drug concentrations and increase the digoxin dose as needed (see prescribing information for … |
| Levodopa | drug interactions | Examples; apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine |
| Paroxetine | drug interactions | Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine): See Full Prescribing Information for recommended dosage reductions. |
| Posaconazole | drug interactions | … decreased or increased drug exposure. Intervention Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oral suspension*, fosfomycin): Monitor for reduced therapeutic effect of the interacting drug. … |
Every other medicine the metoclopramide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Pramipexole | drug interactions | Examples; apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine |
| Quinidine | drug interactions | Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine): See Full Prescribing Information for recommended dosage reductions. |
| Ropinirole | drug interactions | Examples; apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine |
| Rotigotine | drug interactions | Examples; apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine |
| Sirolimus | drug interactions | … prescribing information for digoxin). Drugs with Increased Absorption (e.g., sirolimus, tacrolimus, cyclosporine): Monitor therapeutic drug concentrations and adjust the dose as needed. … |
| Succinylcholine | drug interactions | Examples Apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, rotigotine Succinylcholine, Mivacurium Clinical Impact Metoclopramide inhibits plasma cholinesterase leading to … |
| Tacrolimus | drug interactions | … information for digoxin). Drugs with Increased Absorption (e.g., sirolimus, tacrolimus, cyclosporine): Monitor therapeutic drug concentrations and adjust the dose as needed. … |
Other labels that name metoclopramide
Source: FDA drug label (Metoclopramide), NDA017854 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective May 18, 2026 (SPL set 797aad80-0597-42f8-99d5-39de180c3b5a), via openFDA; the full label on DailyMed
What do FAERS reports show for metoclopramide?
The FDA Adverse Event Reporting System holds 76,710 reports that list metoclopramide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9,885 are coded as a death and 33,932 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as metoclopramide?
21 other medicines are given the same way (oral) and in the same FDA class as metoclopramide or labeled mainly for the same use (acid reflux and ulcers), the same class first. Acid reflux and ulcers lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Calcium carbonate | Acid reflux and ulcers | none listed | $0.0315 per tablet 750 mg tablet chewable | No current entry |
| Omeprazole | Acid reflux and ulcers | 121 labelers | $0.0295 per capsule 20 mg capsule | A presentation being discontinued |
| Famotidine | Acid reflux and ulcers | 144 labelers | $0.0289 per tablet 20 mg tablet | No current entry |
| Esomeprazole | Acid reflux and ulcers | 117 labelers | $0.145 per capsule 20 mg capsule | No current entry |
| Pantoprazole | Acid reflux and ulcers | 52 labelers | $0.0358 per tablet 40 mg tablet | No current entry |
| Lansoprazole | Acid reflux and ulcers | 59 labelers | $0.106 per capsule 30 mg capsule | No current entry |
| Sucralfate | Acid reflux and ulcers | 43 labelers | $0.173 per tablet 1 g tablet | No current entry |
| Calcium carbonate and famotidine and magnesium hydroxide | Acid reflux and ulcers | 20 labelers | $0.258 per tablet Acid reducer complete tablet chewable | No current entry |
Every medicine labeled for the same conditions as metoclopramide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does metoclopramide compare with medicines for the same use?
9 side-by-side pages set metoclopramide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to metoclopramide
- 21 medicines for the same use
- Other dopamine-2 receptor antagonists
- the pharmacologic class, with prices and generics
- Metoclopramide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other