Metoclopramide 10 mg Tablet, 1,000-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Dopamine-2 Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- It helps your digestive system move food along faster. If you have acid reflux, it tightens the valve between your esophagus and stomach so acid is less likely to back up. If you h...
- What exactly is metoclopramide supposed to do for me?
- This medication is meant to be short-term. For acid reflux, treatment is generally 4 to 12 weeks. For diabetic gastroparesis, it's usually 2 to 8 weeks. Using it longer than recomm...
- The most common ones — restlessness, drowsiness, and fatigue — affect roughly 1 in 10 people and are usually manageable. The ones that need urgent attention are any unusual or repe...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Metoclopramide — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.044 | $43.80 / 1000 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.1804 | $180.40 / 1000 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.0766 | $76.60 / 1000 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metoclopramide 10 mgthis 00093-2203-10 | Teva | 1000 tablets | $0.044 | AB | Availability likely | — |
| Metoclopramide 10 mg 50228-0233-01 | ScieGen | 100 tablets | $0.044 | AB | Availability likely | — |
| Metoclopramide 10 mg 51079-0888-20 | Mylan | 100 tablets | $0.044 | AB | Availability likely | — |
| Metoclopramide 10 mg 60687-0631-01 | American | 100 tablets | $0.044 | AB | Availability likely | — |
| Metoclopramide 10 mg 62559-0296-01 | ANI | 100 tablets | $0.044 | AB | Availability likely | — |
| Metoclopramide 10 mg 83980-0011-01 | Ipca | 100 tablets | $0.044 | AB | Availability likely | — |
| Metoclopramide 10 mg 00615-8285-30 | NCS | 30 tablets | — | AB | Discontinued | — |
| Metoclopramide 10 mg 42291-0596-90 | AvKARE | 90 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 48433-0067-20 | Safecor | 100 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 50090-0132-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 51655-0240-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Reglan 10 mg 62559-0166-01 | ANI | 100 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 63187-0235-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 63629-8745-01 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 66267-0286-20 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 66267-0827-04 | NuCare | 4 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 67046-0581-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 68788-7930-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 70518-0669-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 70518-1193-00 | REMEDYREPACK | 60 tablets | — | AB | Discontinued | — |
| Metoclopramide 10 mg 70518-4541-00 | REMEDYREPACK | 40 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 71335-0362-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 67296-2309-02 | Redpharm | 15 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 53401-0027-01 | Aphena | 1 tablet | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00093-2203-01 | 100 TABLET in 1 BOTTLE (0093-2203-01) | $0.0438 / ea | $4.38 | 1990-09-30 | Active |
| 00093-2203-05 | 500 TABLET in 1 BOTTLE (0093-2203-05) | $0.0438 / ea | $21.92 | 1990-09-30 | Active |
| 00093-2203-10 You're viewing this | 1000 TABLET in 1 BOTTLE (0093-2203-10) | $0.0438 / ea | $43.83 | 1990-09-30 | Active |
You're viewing the largest of 3 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0438 NADAC).
This pack accounts for about 17% of this product's recent Medicaid fills; most go to the 500 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 00093-2203-10?
What is the difference between NDC 00093-2203-10 and NDC 00093-2203-01?
What NDC number is used to bill for this package of Metoclopramide 10 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: 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 is 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 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.
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 )
🎯 Indications and Usage ▾
1 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. Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitations of Use : Metoclopramide tablets 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 )].
Metoclopramide tablets are 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 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 ▾
2 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.
2.1Recommended Dosage for Symptomatic, Documented Gastroesophageal Reflux in Adults Who Fail Conventional Therapy Metoclopramide tablets may be administered continuously or intermittently in patients with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy: Continuous Dosing The recommended dosage of metoclopramide tablets is 10 to 15 mg orally four times daily. The maximum recommended daily oral dosage is 60 mg. Administer each dose thirty minutes before a meal and at bedtime.
The recommended treatment duration is 4 to 12 weeks, as determined by endoscopic response. Use metoclopramide tablets for the shortest duration of treatment and periodically reassess the need for continued treatment. The maximum recommended duration of treatment is 12 weeks [see Warnings and Precautions (5.1)] .
Table 1 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors. Intermittent Dosing If symptoms only occur intermittently or at specific times of the day, administer metoclopramide as a single dose up to 20 mg prior to the provoking situation.
Consider dosage reductions for the populations and situations in Table 1. Table 1. Recommended Dosage of Metoclopramide Tablet for Symptomatic, Documented Gastroesophageal Reflux in Adults Who Fail Conventional Therapy Recommended Dosage Maximum Recommended Daily Dosage Adult patients 10 to 15 mg four times daily (thirty minutes before each meal and at bedtime) 60 mg Mild hepatic impairment (Child-Pugh A) Elderly patients [see Use in Specific Populations ( 8.5 )] 5 mg 1 four times daily (thirty minutes before each meal and at bedtime) Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations ( 8.7 )] 5 mg four times daily (thirty minutes before each meal and at bedtime), or 10 mg taken three times daily 30 mg CYP2D6 poor metabolizers [see Use in Specific Populations ( 8.9 )] Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions ( 7.1 )] Moderate or severe renal impairment (creatinine clearance less than or equal to 60 mL/minute) [see Use in Specific Populations ( 8.6 )] Patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations ( 8.6 )] 5 mg four times daily (thirty minutes before each meal and at bedtime) or 10 mg twice daily 20 mg 1 Elderly patients may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a lower starting dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 to 15 mg four times daily based upon response and tolerability.
2.2 Recommende…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: 5 mg metoclopramide, USP: white, round, unscored, debossed “TV” on one side and “2204” on the other side. 10 mg metoclopramide, USP: white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side. Tablets: 5 mg and 10 mg metoclopramide ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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 [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 ) Hypersensitivity to metoclopramide ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 )
5.1Tardive Dyskinesia Metoclopramide, including metoclopramide tablets, 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. Metoclopramide, including metoclopramide tablets, may also suppress, or partially suppress, the signs of TD, and may delay the diagnosis of TD because it may mask the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown.
TD may remit, partially or completely, if metoclopramide treatment is discontinued. In patients treated with metoclopramide, including metoclopramide tablets, 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 in elderly patients, especially in elderly women [ see Use in Specific Populations ( 8.5 )] , and in patients with diabetes mellitus.
Prevention, Mitigation, and Monitoring for TD Metoclopramide is contraindicated in patients with a history of TD. Avoid use of metoclopramide in patients receiving concomitant antipsychotics due to the potential additive effects of TD [see Drug Interactions ( 7.1 )] . Reduce the metoclopramide dosage in the elderly [see Dosage and Administration ( 2.1 , 2.2 )] .
Use metoclopramide for the shortest duration of treatment and periodically reassess the need for continued treatment. Immediately discontinue metoclopramide in patients who develop signs and symptoms of TD. In patients with symptomatic, documented gastroesophageal reflux, the maximum duration of treatment is 12 weeks [see Dosage and Administration ( 2.2 )] .
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. If patients have continued TD symptoms, consider TD treatment.
5.2Other Extrapyramidal Symptoms In addition to TD, metoclopramide may cause other extrapyramidal symptoms (EPS), parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue metoclopramide. Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patients treated with metoclopramide dosages of 30 mg to 40 mg daily.
Such reactions occurred more frequently in adults less than 30 years of age and at higher than recommended dosages. EPS occurred more frequently in pediatric patients compared to adults (metoclopramide is not approved for use in pediatric patients). Symptoms can occur in the first 24 to 48 hours after starting metoclopramide.
Symptoms included involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions were present as stridor and dyspnea, possibly due to laryngospasm. Diphenhydramine hydrochloride or benztropine mesylate may be used to treat these adverse reactions.
Avoid metoclopramide in patients receiving other drugs that can cause EPS (e.g., antipsychotics). Parkinsonian symptoms (bradykinesia, tremor, cogwheel rigidity, mask-like facies) have occurred after starting metoclopramide, more commonly within the first 6 months, but also after longer periods. Symptoms generally have subsided within 2 to 3 months after dis…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 symptoms [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 and duration of metoclopramide administration.
Adverse reactions, especially those involving the nervous system, occurred after stopping metoclopramide including dizziness, nervousness, and headaches. Central Nervous System Disorders Tardive dyskinesia, acute dystonic reactions, drug-induced parkinsonism, akathisia, and other extrapyramidal symptoms Convulsive seizures Hallucinations Restlessness, drowsiness, fatigue, and lassitude occurred in approximately 10% of patients who received 10 mg four times daily. Insomnia, headache, confusion, dizziness, or depression with suicidal ideation occurred less frequently.
Neuroleptic malignant syndrome, serotonin syndrome (in combination with serotonergic agents). Endocrine Disorders : Fluid retention secondary to transient elevation of aldosterone. Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia Cardiovascular Disorders : Acute congestive heart failure, possible atrioventricular block, hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention Gastrointestinal Disorders : Nausea, bowel disturbances (primarily diarrhea) Hepatic Disorders : Hepatotoxicity, characterized by, e.g., jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential Renal and Urinary Disorders : Urinary frequency, urinary incontinence Hematologic Disorders : Agranulocytosis, neutropenia, leukopenia, methemoglobinemia, sulfhemoglobinemia Hypersensitivity Reactions : Bronchospasm (especially in patients with a history of asthma), urticaria; rash; angioedema, including glossal or laryngeal edema Eye Disorders : Visual disturbances Metabolism Disorders : Porphyria 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 ▾
7 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 )
7.1Effects of Other Drugs on Metoclopramide Table 3 displays the effects of other drugs on metoclopramide. Table 3. Effects of Other Drugs on Metoclopramide Antipsychotics Clinical Impact Potential for additive effects, including increased frequency and severity of tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS).
Intervention Avoid concomitant use [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Strong CYP2D6 Inhibitors, not Included in Antipsychotic Category Above Clinical Impact Increased plasma concentrations of metoclopramide; risk of exacerbation of extrapyramidal symptoms [see Clinical Pharmacology ( 12.3 )] . Intervention Reduce the metoclopramide dosage [ see Dosage and Administration ( 2.1 , 2.2 ) ].
Examples quinidine, bupropion, fluoxetine, and paroxetine Monoamine Oxidase Inhibitors Clinical Impact Increased risk of hypertension [see Warnings and Precautions ( 5.5 )] . Intervention Avoid concomitant use. Central Nervous System (CNS) Depressants Clinical Impact Increased risk of CNS depression [see Warnings and Precautions ( 5.8 )] .
Intervention Avoid metoclopramide or the interacting drug, depending on the importance of the drug to the patient. Examples alcohol, sedatives, hypnotics, opiates and anxiolytics Drugs that Impair Gastrointestinal Motility Clinical Impact Decreased systemic absorption of metoclopramide. Intervention Monitor for reduced therapeutic effect.
Examples antiperistaltic antidiarrheal drugs, anticholinergic drugs, and opiates Dopaminergic Agonists and Other Drugs that Increase Dopamine Concentrations Clinical Impact Decreased therapeutic effect of metoclopramide due to opposing effects on dopamine. Intervention Monitor for reduced therapeutic effect. Examples apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine
7.2Effects of Metoclopramide on Other Drugs Table 4 displays the effects of metoclopramide on other drugs. Table 4. Effects of Metoclopramide on Other Drugs Dopaminergic Agonists and Drugs Increasing Dopamine Concentrations Clinical Impact Opposing effects of metoclopramide and the interacting drug on dopamine.
Potential exacerbation of symptoms (e.g., parkinsonian symptoms). Intervention Avoid concomitant use [see Warnings and Precautions ( 5.2 )] . Examples Apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, rotigotine Succinylcholine, Mivacurium Clinical Impact Metoclopramide inhibits plasma cholinesterase leading to enhanced neuromuscular blockade.
Intervention Monitor for signs and symptoms of prolonged neuromuscular blockade Drugs with Absorption Altered due to Increased Gastrointestinal Motility Clinical Impact The effect of metoclopramide on other drugs is variable. Increased gastrointestinal (GI) motility by metoclopramide may impact absorption of other drugs leading to decreased or increased drug exposure. Intervention Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oral suspension Interaction does not apply to posaconazole delayed-release tablets , 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 digoxin). Drugs with Increased Absorption (e.g., sirolimus, tacrolimus…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery ( see Clinical Considerations) . In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) ( see Data) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. Monitor neonates for extrapyramidal signs [see Warnings and Precautions ( 5.1 , 5.2 ), Use in Specific Populations ( 8.4 )] . Data Animal Data Reproduction studies have been performed following administration of oral metoclopramide during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area.
No evidence of adverse developmental effects due to metoclopramide were observed.
8.2Lactation Risk Summary Limited published data report the presence of metoclopramide in human milk in variable amounts ( see Data) . Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation ( see Clinical Considerations) . Metoclopramide elevates prolactin levels [ see Warnings and Precautions ( 5.7 )] ; however, the published data are not adequate to support drug effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for metoclopramide and any potential adverse effects on the breastfed child from metoclopramide or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding neonates because metoclopramide may cause extrapyramidal signs (dystonias) and methemoglobinemia [see Warnings and Precautions ( 5.1 , 5.2 ), Use in Specific Populations ( 8.4 )] . Data In published clinical studies, the estimated amount of metoclopramide received by the breastfed infant was less than 10% of the maternal weight-adjusted dose.
In one study, the estimated daily amount of metoclopramide received by infants from breast milk ranged from 6 to 24 mcg/kg/day in early puerperium (3 to 9 days postpartum) and from 1 to 13 mcg/kg/day at 8 to 12 weeks postpartum.
8.4Pediatric 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. The safety and effectiveness of metoclopramide tablets in pediatric patients have not been established. Dystonias and other extrapyramidal symptoms associated with metoclopramide are more common in pediatric patients than in adults [see Warnings and Precautions ( 5.1 , 5.2 )] .
In addition, neonates have reduced levels of NADH-cytochrome b 5 reductase, making them more susceptible to methemoglobinemia, a possible adverse reaction of metoclopramide use in neonates [see Use in Specific Populations ( 8.8 )] .
8.5Geriatric Use Metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (TD), m…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery ( see Clinical Considerations) . In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) ( see Data) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. Monitor neonates for extrapyramidal signs [see Warnings and Precautions ( 5.1 , 5.2 ), Use in Specific Populations ( 8.4 )] . Data Animal Data Reproduction studies have been performed following administration of oral metoclopramide during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area.
No evidence of adverse developmental effects due to metoclopramide were observed.
🧒 Pediatric Use ▾
8.4Pediatric 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. The safety and effectiveness of metoclopramide tablets in pediatric patients have not been established. Dystonias and other extrapyramidal symptoms associated with metoclopramide are more common in pediatric patients than in adults [see Warnings and Precautions ( 5.1 , 5.2 )] .
In addition, neonates have reduced levels of NADH-cytochrome b 5 reductase, making them more susceptible to methemoglobinemia, a possible adverse reaction of metoclopramide use in neonates [see Use in Specific Populations ( 8.8 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (TD), may be greater in patients with impaired renal function [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a reduced dosage of metoclopramide in elderly patients [see Boxed Warning , Dosage and Administration ( 2.1 , 2.2 ), Warnings and Precautions ( 5.1 )] .
🆘 Overdosage ▾
10 OVERDOSAGE Manifestations of metoclopramide overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with metoclopramide use (including, e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has been reported in association with metoclopramide overdose and concomitant treatment with another drug associated with NMS [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . There are no specific antidotes for metoclopramide overdosage.
If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage. Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, which may be fatal.
Hemodialysis and continuous ambulatory peritoneal dialysis do not remove significant amounts of metoclopramide.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of metoclopramide in the treatment of gastroesophageal reflux and acute and recurrent diabetic gastroparesis has not been fully established. It seems to sensitize tissues to the action of acetylcholine.
The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs. Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter.
It has little, if any, effect on the motility of the colon or gallbladder.
12.2Pharmacodynamics Gastroesophageal Reflux In patients with gastroesophageal reflux and low lower esophageal sphincter pressure (LESP), single oral doses of metoclopramide produced dose-related increases in LESP. Effects began at about 5 mg and increased through 20 mg. The increase in LESP from a 5 mg dose lasted about 45 minutes and that of 20 mg lasted between 2 and 3 hours.
Increased rate of stomach emptying was observed with single oral doses of 10 mg.
12.3Pharmacokinetics Absorption Relative to an intravenous dose of 20 mg, the absolute bioavailability of oral metoclopramide is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occurred at about 1 to 2 hours after a single oral dose. Similar time to peak was observed after individual doses at steady state.
In a single dose study of 12 subjects, the area under the drug concentration-time curve increased linearly with doses from 20 to 100 mg (5 times the maximum recommended single dose). Peak concentrations increased linearly with dose; time to peak concentrations remained the same; whole body clearance was unchanged; and the elimination rate remained the same. The mean elimination half-life in subjects with normal renal function was 5 to 6 hours.
Linear kinetic processes adequately describe the absorption and elimination of metoclopramide. Distribution Metoclopramide is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about
3.5L/kg), which suggests extensive distribution of drug to the tissues. Elimination Metabolism: Metoclopramide undergoes enzymatic metabolism via oxidation as well as glucuronide and sulfate conjugation reactions in the liver. Monodeethylmetoclopramide, a major oxidative metabolite, is formed primarily by CYP2D6, an enzyme subject to genetic variability [see Dosage and Administration ( 2.1 , 2.2 ), Use in Specific Populations ( 8.9 )] .
Excretion: Approximately 85% of the radioactivity of an orally administered dose appeared in the urine within 72 hours. After oral administration of 10 or 20 mg, a mean of 18% and 22% of the dose, respectively, was recovered as free metoclopramide in urine within 36 hours. Specific Populations Patients with Renal Impairment: In a study of 24 patients with varying degrees of renal impairment (moderate, severe, and end-stage renal disease (ESRD) requiring dialysis), the systemic exposure (AUC) of metoclopramide in patients with moderate to severe renal impairment was about 2-fold the AUC in subjects with normal renal function.
The AUC of metoclopramide in patients with ESRD on dialysis was about 3.5-fold the AUC in subjects with normal renal function [see Dosage and Administration ( 2.1 , 2.2 ) and Use in Specific Populations ( 8.6 )] . Patients with Hepatic Impairment: In a group of 8 patients with severe hepatic impairment (Child-Pugh C), the average metoclopramide clearance was reduced by approximately 50% compared to patients with normal hepatic function [see Dosage and Administra…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of metoclopramide in the treatment of gastroesophageal reflux and acute and recurrent diabetic gastroparesis has not been fully established. It seems to sensitize tissues to the action of acetylcholine.
The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs. Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter.
It has little, if any, effect on the motility of the colon or gallbladder.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each white, round, unscored, debossed “TV” on one side and “2204” on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 5 mg metoclopramide. Available in bottles of 100 (NDC 0093-2204-01) and 500 (NDC 0093-2204-05). Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide.
Available in bottles of 100 (NDC 0093-2203-01), 500 (NDC 0093-2203-05), and 1,000 (NDC 0093-2203-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT.
This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Dispense in a tight, light-resistant container.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
📋 Description ▾
11 DESCRIPTION Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether.
Chemically, it is 4-amino-5-chloro- N -[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows: C 14 H 22 ClN 3 O 2 •HCl•H 2 O M.W. 354.3 Metoclopramide tablets, USP are for oral administration.
Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP). Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP).
Inactive Ingredients Corn starch, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. \\Client\X$\Products\Metoclopramide Tablets USP, 10 mg (ANDA 070184)\Submissions\2017-08-30 CBE-0 - AJK\Working\INSERT\Images\metoclopramide-sf1.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Tardive Dyskinesia and/or other Extrapyramidal Reactions Inform patients that metoclopramide tablets may cause tardive dyskinesia or other extrapyramidal symptoms, parkinsonian symptoms, and motor restlessness. Instruct patients to immediately discontinue metoclopramide tablets and contact their healthcare provider if symptoms occur [ see Warnings and Precautions ( 5.1 , 5.2 )] .
Neuroleptic Malignant Syndrome Inform patients that serious neuroleptic malignant syndrome (NMS) has been reported in association with concomitant treatment with another drug associated with NMS. Advise patients to report all prescription and over-the-counter medications to the healthcare provider. Instruct patients to immediately discontinue metoclopramide tablets and seek medical attention if symptoms occur [ see Warnings and Precautions ( 5.3 )] .
Depression and/or Possible Suicidal Ideation Inform patients that symptoms of new onset or worsening depression as well as suicidal ideation have been reported in patients taking metoclopramide. Instruct patients to immediately discontinue metoclopramide tablets and contact their healthcare provider if any of these symptoms occur [ see Warnings and Precautions ( 5.4 )] . Drug Interactions Inform patients or their caregivers that concomitant treatment with numerous other medications can precipitate or worsen serious adverse reactions such as tardive dyskinesia or other extrapyramidal reactions, neuroleptic malignant syndrome, and CNS depression [ see Drug Interactions ( 7.1 , 7.2 )] .
Explain that the prescriber of any other medication must be made aware that the patient is taking metoclopramide tablets. Effects on the Ability to Drive and Operate Machinery Inform patients or their caregivers that metoclopramide tablets can cause drowsiness or dizziness, or otherwise impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle [ see Warnings and Precautions ( 5.8 )] . Manufactured In Croatia By: Pliva Hrvatska d.o.o.
Zagreb, Croatia Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. S 3/2026
💬 Medication Guide ▾
MEDICATION GUIDE Metoclopramide (met'' oh kloe' pra mide) Tablets Read this Medication Guide before you start taking metoclopramide tablets and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as metoclopramide injection, metoclopramide orally disintegrating tablets, or metoclopramide oral solution), you should read the Medication Guide that comes with that product.
Some of the information may be different. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. 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. What are metoclopramide tablets? Metoclopramide tablets are a prescription medicine used in adults: for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux when certain other treatments do not work. to relieve the symptoms of slow stomach emptying in people with diabetes.
Metoclopramide tablets are not recommended for use in children or for longer than 12 weeks if you are being treated to relieve heart burn symptoms with gastroesophageal reflux. Do not take metoclopramide tablets if you: have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking metoclopramide tablets or a medicine that works like metoclopramide tablets. have stomach or intestine problems that could get worse with metoclopramide tablets, such as bleeding, blockage or a tear in the stomach or bowel wall. have a type of tumor that can cause high blood pressure such as pheochromocytoma. have epilepsy (seizures).
Metoclopramide tablets can increase your chance for seizures and make them worse. are allergic to metoclopramide. Metoclopramide tablets can cause serious allergic reactions. Stop taking metoclopramide tablets right away and get emergency help if you have any of these symptoms: swelling of your tongue, throat, lips, eyes or face. trouble swallowing or breathing. skin rash, hives, sores in your mouth, or skin blisters.
Before taking metoclopramide tablets, tell your healthcare provider about all of your medical conditions, including if you: had problems controlling…