pharmacopeia
GET
/api/v1/drug/metoclopramide

Boxed warning

TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia. See WARNINGS

2D structure
4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide
SMILES CCN(CC)CCNC(=O)C1=CC(=C(C=C1OC)N)Cl
InChIKey TTWJBBZEZQICBI-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Dopamine Antagonists; Dopamine D2 Antagonists.

DopamineDopamine D2

Indications

Sourced from openFDA
  • The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration.

Contraindications

Sourced from openFDA
  • Metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor.contraindicated

Dosage & administration

Sourced from openFDA

Therapy with metoclopramide oral solution should not exceed 12 weeks in duration. For the Relief of Symptomatic Gastroesophageal Reflux Administer from 10 mg to 15 mg metoclopramide orally up to 4 times daily 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE ). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose. Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using 4 times daily therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS ). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation. Therapy longer than 12 weeks has not been evaluated and cannot be recommended. For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis) Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

Warnings & precautions

Sourced from openFDA

Mental depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks. Extrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at the higher doses. These symptoms may include 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 may present as stridor and dyspnea, possibly due to laryngospasm. If these symptoms should occur, inject 50 mg diphenhydramine hydrochloride intramuscularly, and they usually will subside. Benztropine mesylate, 1 to 2 mg intramuscularly, may also be used to reverse these reactions. Parkinsonian-like symptoms have occurred, more commonly within the first 6 months after beginning treatment with metoclopramide, but occasionally after longer periods. These symptoms generally subside within 2 to 3 months following discontinuance of metoclopramide.

Adverse reactions

Sourced from openFDA

In general, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency: CNS Effects Restlessness, drowsiness, fatigue, and lassitude occur in approximately 10% of patients receiving the most commonly prescribed dosage of 10 mg 4 times daily. (see PRECAUTIONS ). Insomnia, headache, confusion, dizziness or mental depression with suicidal ideation (see WARNINGS ) occur less frequently. The incidence of drowsiness is greater at higher doses. There are isolated reports of convulsive seizures without clearcut relationship to metoclopramide. Rarely, hallucinations have been reported. Extrapyramidal Reactions (EPS) Acute dystonic reactions, the most common type of EPS associated with metoclopramide, occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 mg of metoclopramide per day. Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonus (tetanus-like reactions), and, rarely, stridor and dyspnea possibly due to laryngospasm; ordinarily these symptoms are readily reversed by diphenhydramine (see WARNINGS ). Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity, mask-like facies (see WARNINGS ).

Pharmacokinetics

Sourced from openFDA
Metabolism
Metoclopramide is rapidly and well absorbed. Relative to an intravenous dose of 20 mg, the absolute oral bioavailability of metoclopramide is 80% ±15.5% as demonstrated in a crossover study of 18 subjects.

Overdosage

Sourced from openFDA

Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal reactions. Anticholinergic or antiparkinson drugs or antihistamines with anticholinergic properties may be helpful in controlling the extrapyramidal reactions. Symptoms are self-limiting and usually disappear within 24 hours. Hemodialysis removes relatively little metoclopramide, probably because of the small amount of the drug in blood relative to tissues. Similarly, continuous ambulatory peritoneal dialysis does not remove significant amounts of drug. It is unlikely that dosage would need to be adjusted to compensate for losses through dialysis. Dialysis is not likely to be an effective method of drug removal in overdose situations. Unintentional overdose due to misadministration has been reported in infants and children with the use of metoclopramide oral solution. While there was no consistent pattern to the reports associated with these overdoses, events included seizures, extrapyramidal reactions, and lethargy.

Approval history

Sourced from openFDA
  • Dec 30, 1980NDANDA017854Ani Pharms
  • Jul 29, 1985ANDAANDA070184Teva
  • Jan 30, 1990ANDAANDA072215Aiping Pharm Inc
  • Jan 17, 1991ANDAANDA073118Hospira
  • May 28, 1991ANDAANDA072744Pai Holdings
  • Nov 27, 1991ANDAANDA073135Teva Pharms Usa
  • Oct 27, 1992ANDAANDA073680Chartwell Molecular
  • Jun 19, 2020NDANDA209388Qol Medcl

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
75,808 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Tardive Dyskinesia16,21821%
  2. 2Extrapyramidal Disorder12,91317%
  3. 3Nervous System Disorder7,5259.9%
  4. 4Dystonia7,1009.4%
  5. 5Nausea6,3858.4%
  6. 6Pain5,9417.8%
  7. 7Vomiting4,8756.4%
  8. 8Anxiety4,0755.4%
  9. 9Diarrhoea4,0215.3%
  10. 10Economic Problem3,9615.2%
  11. 11Incorrect Drug Administration Duration3,7104.9%
  12. 12Fatigue3,4494.5%
  13. 13Movement Disorder3,2724.3%
  14. 14Dyspnoea3,2264.3%
  15. 15Dyskinesia3,2214.2%

Literature

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Recent PubMed references pinned to Metoclopramide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 221 ClinicalTrials.gov registrations naming Metoclopramide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Metoclopramide. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CYB5R1CPIC D (provisional)FDA label: Informative PGx
  • CYB5R2CPIC D (provisional)FDA label: Informative PGx
  • CYB5R3CPIC D (provisional)FDA label: Informative PGx
  • CYB5R4CPIC D (provisional)FDA label: Informative PGx
  • CYP2D6CPIC B/C (provisional)FDA label: Actionable PGx

Frequently asked questions

How does Metoclopramide work?
Mechanism-of-action classes: Dopamine Antagonists; Dopamine D2 Antagonists.
What is Metoclopramide used for?
According to FDA labeling, Metoclopramide carries indications including: The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Metoclopramide?
Metoclopramide is classified as Propulsives, Dopamine-2 Receptor Antagonist, Dopamine Antagonists, Dopamine D2 Antagonists, Increased GI Motility.
What are the brand names for Metoclopramide?
Metoclopramide is marketed under brand names including Gimoti, Metozolv, Pileran, Reglan.
What are the contraindications for Metoclopramide?
Metoclopramide labeling lists contraindications including: Metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor.. Always consult the full prescribing information and a clinician.
Note. Data for metoclopramide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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