Medical Editor: John P. Cunha, DO, FACOEP
Metozolv ODT (metoclopramide hydrochloride) is a prokinetic drug that is used short-term to treat heartburn caused by gastroesophageal reflux in people who have used other medications without relief of symptoms. Metozolv ODT is also used to treat slow gastric emptying in people with diabetes (also called diabetic gastroparesis), which can cause:
- sleep problems (insomnia)
- breast tenderness or swelling
- changes in your menstrual periods, or
- urinating more than usual
The dose of Metozolv ODT is 10 mg to 15 mg taken up to four times daily (e.g., at least 30 minutes before each meal and at bedtime). Metozolv ODT may interact with other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotics, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), acetaminophen (Tylenol), cyclosporine, digoxin, glycopyrrolate, insulin, levodopa, mepenzolate, tetracycline, atropine, benztropine, dimenhydrinate, methscopolamine, scopolamine, bladder or urinary medications, bronchodilators, irritable bowel medications, MAO inhibitors, or medicines to treat psychiatric disorders. Tell your doctor all medications and supplements you use. Metozolv ODT is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This drug can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.
Our Metozolv ODT (metoclopramide hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop taking metoclopramide and call your doctor at once if you have any of these SIGNS OF A SERIOUS MOVEMENT DISORDER, which may occur within the first 2 days of treatment:
- tremors or shaking in your arms or legs;
- uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or
- any new or unusual muscle movements you cannot control.
Call your doctor at once if you have:
- confusion, depression, thoughts of suicide or hurting yourself;
- slow or jerky muscle movements, problems with balance or walking;
- mask-like appearance in your face;
- a seizure;
- anxiety, agitation, jittery feeling, trouble staying still, trouble sleeping;
- swelling, feeling short of breath, rapid weight gain; or
- severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.
Common side effects may include:
- feeling restless;
- feeling drowsy or tired;
- lack of energy;
- nausea, vomiting;
- headache, confusion; or
- sleep problems (insomnia).
Read the entire detailed patient monograph for Metozolv (Metoclopramide Hydrochloride Orally Disintegrating Tablets)
The following adverse reactions are described, or described in greater detail, in other sections of the labeling:
- Tardive dyskinesia [see BOX WARNING and WARNINGS AND PRECAUTIONS]
- Other extrapyramidal effects [see WARNINGS AND PRECAUTIONS]
- Neuroleptic malignant syndrome [see WARNINGS AND PRECAUTIONS]
- Depression [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Fluid retention [see WARNINGS AND PRECAUTIONS]
- Hyperprolactinemia [see WARNINGS AND PRECAUTIONS]
- Effects on the ability to drive and operate machinery [see WARNINGS AND PRECAUTIONS]
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
- 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
Read the entire FDA prescribing information for Metozolv (Metoclopramide Hydrochloride Orally Disintegrating Tablets)
© Metozolv Patient Information is supplied by Cerner Multum, Inc. and Metozolv Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.