Metoclopramide 5 mg Tablets — Generic For Reglan — TEVA

These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS.

METOCLOPRAMIDE tablets, for oral use

Initial U.S. Approval: 1979

Warning: Tardive Dyskinesia

See full prescribing information for complete boxed warning.

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 metoclopramide treatment and total cumulative metoclopramide dosage. (5.1)

Metoclopramide is contraindicated in patients with a history of TD. (4)

Use metoclopramide for the shortest duration of treatment and periodically reassess the need for continued treatment. (2.1, 2.2, 5.1)

Immediately discontinue metoclopramide in patients who develop signs or symptoms of TD. (5.1)

In patients with symptomatic, documented gastroesophageal reflux, the maximum duration of treatment is 12 weeks. (2.1, 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. (5.1)

Recent Major Changes

Boxed Warning 02/2026

Indications and Usage (1) 02/2026

Dosage and Administration (2.1, 2.2) 02/2026

Warnings and Precautions, Tardive Dyskinesia (5.1) 02/2026

Warnings and Precautions, Other Extrapyramidal Symptoms (5.2) 02/2026

Indications And Usage

Metoclopramide tablets are 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 tablets have not been shown to be safe and effective for the treatment of gastroesophageal reflux for longer than 12 weeks. (1, 5.1)

Metoclopramide tablets are 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)

Dosage And Administration

Symptomatic, Documented Gastroesophageal Reflux in Adults Who Fail Conventional Therapy (2.1)

Administer metoclopramide continuously or intermittently:

Continuous: The recommended dosage is 10 to 15 mg orally, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks, as determined by endoscopic response.

Intermittent: Single doses up to 20 mg prior to provoking situation.

Acute and Recurrent Diabetic Gastroparesis in Adults (2.2)

The recommended dosage is 10 mg orally, 30 minutes before each meal and at bedtime (maximum of 40 mg per day).

Dosage Adjustment in Specific Populations (2.1, 2.2)

For symptomatic, documented gastroesophageal reflux and acute and recurrent diabetic gastroparesis, see Full Prescribing Information for recommended dosage reductions for elderly patients, in patients with moderate or severe hepatic or renal impairment, and cytochrome P450 2D6 (CYP2D6) poor metabolizers.

Dosage Forms And Strengths

Tablets: 5 mg and 10 mg metoclopramide (3)

Contraindications

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)

Hypersensitivity to metoclopramide (4)

Warnings And Precautions

• , Tardive Dyskinesia (5.1) 02/2026 Warnings and Precautions, Other Extrapyramidal Symptoms (5.2) 02/2026 INDICATIONS AND USAGE Metoclopramide tablets are 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 tablets have not been shown to be safe and effective for the treatment of gastroesophageal reflux for longer than 12 weeks. (1, 5.1)
• Metoclopramide tablets are 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) DOSAGE AND ADMINISTRATION Symptomatic, Documented Gastroesophageal Reflux in Adults Who Fail Conventional Therapy (2.1)
• Administer metoclopramide continuously or intermittently:
• Continuous: The recommended dosage is 10 to 15 mg orally, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks, as determined by endoscopic response.
• Intermittent: Single doses up to 20 mg prior to provoking situation. Acute and Recurrent Diabetic Gastroparesis in Adults (2.2)

• , Tardive Dyskinesia (5.1) 02/2026 Warnings and Precautions, Other Extrapyramidal Symptoms (5.2) 02/2026 INDICATIONS AND USAGE Metoclopramide tablets are 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 tablets have not been shown to be safe and effective for the treatment of gastroesophageal reflux for longer than 12 weeks. (1, 5.1)
• Metoclopramide tablets are 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) DOSAGE AND ADMINISTRATION Symptomatic, Documented Gastroesophageal Reflux in Adults Who Fail Conventional Therapy (2.1)
• Administer metoclopramide continuously or intermittently:
• Continuous: The recommended dosage is 10 to 15 mg orally, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks, as determined by endoscopic response.
• Intermittent: Single doses up to 20 mg prior to provoking situation. Acute and Recurrent Diabetic Gastroparesis in Adults (2.2)

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)

Adverse Reactions

Most common adverse reactions (> 10%) are restlessness, drowsiness, fatigue, and lassitude. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Antipsychotics: Potential for additive effects, including TD, EPS, and NMS; avoid concomitant use. (7.1)

Central Nervous System (CNS) depressants: Increased risk of CNS depression. Avoid concomitant use and monitor for adverse reactions. (7.1)

Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine): See Full Prescribing Information for recommended dosage reductions. (2.1, 2.3, 7.1)

Monoamine oxidase (MAO) inhibitors: Increased risk of hypertension; avoid concomitant use. (5.5, 7.1)

Additional drug interactions: See Full Prescribing Information. (7.1, 7.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 3/2026