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Metozolv ODT

Metozolv Side Effects Center

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. It is also used to treat slow gastric emptying in people with diabetes (also called diabetic gastroparesis), which can cause nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness after meals. Common side effects include restlessness, drowsiness, tiredness, dizziness, headache, insomnia, nausea, vomiting, diarrhea, 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Metozolv in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty 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.

Stop taking metoclopramide and call your doctor at once if you have any of these other serious side effects:

  • slow or jerky muscle movements, problems with balance or walking;
  • mask-like appearance in your face;
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
  • depressed mood, thoughts of suicide or hurting yourself;
  • hallucinations, anxiety, agitation, jittery feeling, trouble staying still;
  • swelling, feeling short of breath, rapid weight gain;
  • jaundice (yellowing of your skin or eyes); or
  • seizure (convulsions).

Less serious side effects may include:

  • feeling restless, drowsy, tired, or dizzy;
  • headache, sleep problems (insomnia);
  • nausea, vomiting, diarrhea;
  • breast tenderness or swelling;
  • changes in your menstrual periods; or
  • urinating more than usual.

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.

Read the entire detailed patient monograph for Metozolv (Metoclopramide Hydrochloride Orally Disintegrating Tablets) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Metozolv FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

A total of 86 subjects entered three studies with METOZOLV ODT; 12 subjects entered a pilot bioavailability study (BA); 44 subjects entered a bioequivalence (BE) study, and 30 subjects entered a food-effect study. The adverse reactions from the BE and food-effect study are summarized in Table 1. The pilot BA study data are not included because it was performed with a formulation different from the METOZOLV ODT formulation.

The adverse experience profile seen with METOZOLV ODT was similar to metoclopramide tablets. Thirty-three (33) adverse reactions were reported after receiving METOZOLV ODT and 30 adverse reactions were reported after receiving metoclopramide tablets.

Table 1: Adverse Reactions in BE and Food-Effect Study in ≥ 2% of Subjects

Adverse Reaction METOZOLV ODT
N1,3 (%)2
Metoclopramide tablets
N1,4 (%)2
Nausea 4 (4.2 %) 4 (5.6 %)
Vomiting 2(2.1%) 1(1.4%)
Fatigue 2(2.1%) 2 (2.8 %)
Headache 5 (5.2 %) 3 (4.2 %)
Somnolence 2(2.1%) 2 (2.8 %)
Dizziness 1(1.0%) 3 (4.2 %)
1 N = number of subjects that reported adverse reactions
2 Percent (%) occurrence = N divided by number of subjects dosed with respective study drug
3 Number of subjects dosed with METOZOLV ODT: 68 under fasted conditions and 28 under fed conditions.
4 Number of subjects dosed with metoclopramide tablets: 28 under fed conditions and 44 under fasted conditions.

The most frequently reported adverse reactions (greater than 2%) associated with METOZOLV ODT were: nausea, vomiting, fatigue, somnolence and headache. The most frequently reported adverse reactions (greater than 2%) associated with metoclopramide tablets were: nausea, headache, fatigue, somnolence, and dizziness. The combined data from the fasted BE study and the food-effect study did not demonstrate any significant differences in the adverse event profile for METOZOLV ODT compared to metoclopramide tablets.

Post-Marketing Experience

The following adverse reactions are from the cumulative post-marketing experience with metoclopramide tablets. Since the 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.

CNS Effects: Restlessness, drowsiness, fatigue, and lassitude occur in approximately 10% of patients receiving the most commonly prescribed dosage of 10 mg four times a day. Insomnia, headache, confusion, dizziness, or depression with suicidal ideation occurs less frequently. The incidence of drowsiness is greater at higher doses. There are isolated reports of seizures without clear-cut relationship to metoclopramide. Rarely, hallucinations have been reported.

Extrapyramidal Syndromes (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 AND PRECAUTIONS].

Drug-induced Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity, mask-like facies [see WARNINGS and PRECAUTIONS].

Tardive dyskinesia is most frequently characterized by involuntary movements of the tongue, face, mouth, or jaw, and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance. Motor restlessness (akathisia) may include inability to sit still, pacing, and foot tapping. These symptoms may disappear spontaneously or respond to a reduction in dosage.

Neuroleptic Malignant Syndrome: Rare occurrences of Neuroleptic Malignant Syndrome (NMS) have been reported [see WARNINGS AND PRECAUTIONS].

Endocrine Disturbances: Galactorrhea, amenorrhea, gynecomastia, and impotence secondary to hyperprolactinemia. Fluid retention secondary to transient elevation of aldosterone.

Cardiovascular: Hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention, acute congestive heart failure, possible AV block.

Gastrointestinal: Nausea, bowel disturbances, primarily diarrhea.

Hepatic: Rarely, cases of hepatotoxicity characterized by such findings as jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential.

Renal: Urinary frequency and incontinence.

Hematologic: A few cases of neutropenia, leukopenia, or agranulocytosis, generally without clear-cut relationship to metoclopramide. Methemoglobinemia in adults and especially with overdosage in neonates. Sulfhemoglobinemia in adults.

Allergic Reactions: A few cases of rash, urticaria, or bronchospasm, especially in patients with a history of asthma. Rarely, angioneurotic edema, including glossal or laryngeal edema.

Miscellaneous: Visual disturbances. Porphyria.

Read the entire FDA prescribing information for Metozolv (Metoclopramide Hydrochloride Orally Disintegrating Tablets) »

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