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Metoclopramide orally disintegrating tablets

Pronunciation

Generic Name: metoclopramide (MET-oh-KLOE-pra-mide)
Brand Name: Metozolv ODT

Metoclopramide orally disintegrating tablets may cause a serious movement disorder called tardive dyskinesia, which may be permanent. The risk may be increased in patients who use high doses or who take metoclopramide orally disintegrating tablets for a long period of time. The risk may also be increased in the elderly, women, and diabetic patients. Tell your doctor right away if you develop muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements).

Metoclopramide orally disintegrating tablets should usually not be used for longer than 12 weeks.


Metoclopramide orally disintegrating tablets are used for:

Short term treatment of gastroesophageal reflux disease (GERD) in certain patients who do not respond to other therapy. It is used to treat symptoms of a certain digestive problem in diabetic patients (diabetic gastroparesis). It may also be used for other conditions as determined by your doctor.

Metoclopramide orally disintegrating tablets are a gastrointestinal stimulant and antinauseant. It works by increasing the movement of the stomach and intestines to help move food and acid out of the stomach more quickly. It also works in certain areas in the brain to decrease nausea.

Do NOT use metoclopramide orally disintegrating tablets if:

  • you are allergic to any ingredient in metoclopramide orally disintegrating tablets
  • you have seizures (eg, epilepsy); bleeding, blockage, or perforation in your stomach or intestines; or tumors on your adrenal gland (pheochromocytoma)
  • you are taking cabergoline or pergolide
  • you are taking medicines, such as phenothiazines (eg, chlorpromazine), that may cause extrapyramidal reactions (abnormal, involuntary muscle movements of the head, neck, or limbs). Check with your doctor if you are unsure if any of your medicines may cause extrapyramidal reactions.

Contact your doctor or health care provider right away if any of these apply to you.

Before using metoclopramide orally disintegrating tablets:

Some medical conditions may interact with metoclopramide orally disintegrating tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or actions
  • if you have a history of asthma, heart problems (eg, heart failure, heart rhythm problems); high blood pressure, diabetes, Parkinson disease, blood problems (eg, porphyria), kidney problems, liver problems (eg, cirrhosis), breast cancer, low levels of an enzyme called methemoglobin reductase, or low levels of an enzyme called glucose-6-phosphate dehydrogenase
  • if you are taking another form of metoclopramide (eg, oral solution, tablet)
  • if you drink alcohol

Some MEDICINES MAY INTERACT with metoclopramide orally disintegrating tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) because the risk of serious side effects (eg, high blood pressure, seizures) may be increased
  • Anticholinergic medicine (eg, hyoscyamine) or narcotic pain medicines (eg, codeine) because they may decrease metoclopramide orally disintegrating tablets's effectiveness
  • Acetaminophen, benzodiazepines (eg, diazepam), cyclosporine, insulin, levodopa, phenothiazines (eg, chlorpromazine), sedatives (eg, zolpidem), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), succinylcholine, or tetracycline because the risk of their side effects may be increased by metoclopramide orally disintegrating tablets
  • Cabergoline, digoxin, or pergolide because their effectiveness may be decreased by metoclopramide orally disintegrating tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if metoclopramide orally disintegrating tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use metoclopramide orally disintegrating tablets:

Use metoclopramide orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Metoclopramide orally disintegrating tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get metoclopramide orally disintegrating tablets refilled.
  • Take metoclopramide orally disintegrating tablets by mouth 30 minutes before meals and at bedtime without food or water unless directed otherwise by your doctor.
  • Do not remove the tablet from the blister pack until you are ready to take metoclopramide orally disintegrating tablets. Make sure that your hands are dry when you open the blister pack. If the tablet breaks or crumbles while handling, discard and remove a new tablet. Place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.
  • It may take several days to weeks for metoclopramide orally disintegrating tablets to work. Do not stop taking metoclopramide orally disintegrating tablets without checking with your doctor.
  • If you miss a dose of metoclopramide orally disintegrating tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use metoclopramide orally disintegrating tablets.

Important safety information:

  • Metoclopramide orally disintegrating tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use metoclopramide orally disintegrating tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using metoclopramide orally disintegrating tablets without first checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose or use metoclopramide orally disintegrating tablets for longer than 12 weeks without checking with your doctor.
  • Diabetes patients - Metoclopramide orally disintegrating tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Tell your doctor or dentist that you take metoclopramide orally disintegrating tablets before you receive any medical or dental care, emergency care, or surgery.
  • Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by metoclopramide orally disintegrating tablets. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
  • Some patients who take metoclopramide orally disintegrating tablets may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take metoclopramide orally disintegrating tablets in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking metoclopramide orally disintegrating tablets.
  • Patients who take metoclopramide orally disintegrating tablets may be at increased risk for new or worsening mental or mood changes (eg, depression) or suicidal thoughts or actions. Watch patients who take metoclopramide orally disintegrating tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Metoclopramide orally disintegrating tablets may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
  • Lab tests, including liver and kidney function tests, may be performed while you use metoclopramide orally disintegrating tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use metoclopramide orally disintegrating tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness, confusion, and uncontrolled muscle movements, including tardive dyskinesia.
  • Metoclopramide orally disintegrating tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. The risk of developing uncontrolled muscle movements may be greater in children.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using metoclopramide orally disintegrating tablets while you are pregnant. Metoclopramide orally disintegrating tablets are found in breast milk. Do not breast-feed while taking metoclopramide orally disintegrating tablets.

A small number of patients have experienced WITHDRAWAL symptoms when stopping metoclopramide orally disintegrating tablets. These symptoms may include dizziness, nervousness, and headache.

Possible side effects of metoclopramide orally disintegrating tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased energy; diarrhea; dizziness; drowsiness; headache; nausea; restlessness; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); dark urine; decreased balance or coordination; decreased sexual ability; fast, slow, or irregular heartbeat; fever, chills, or sore throat; loss of bladder control; mental or mood changes (eg, abnormal thinking; anxiety; agitation; confusion; depression; hallucinations; jitteriness; suicidal thoughts or actions); seizures; severe or persistent dizziness, headache, or trouble sleeping; severe or persistent restlessness, including inability to sit still; shortness of breath; stiff or rigid muscles; sudden increased sweating; sudden, unusual weight gain; swelling of the arms, legs, or feet; uncontrolled muscle spasms or movements (eg, of the arms, legs, tongue, jaw, cheeks; twitching; tremors); vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; confusion; drowsiness; muscle restlessness; unusual movement of the eyes, face, or limbs.

Proper storage of metoclopramide orally disintegrating tablets:

Store metoclopramide orally disintegrating tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep metoclopramide orally disintegrating tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about metoclopramide orally disintegrating tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Metoclopramide orally disintegrating tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take metoclopramide orally disintegrating tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about metoclopramide orally disintegrating tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to metoclopramide orally disintegrating tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using metoclopramide orally disintegrating tablets.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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