Note: This document contains side effect information about metoclopramide. Some dosage forms listed on this page may not apply to the brand name Metozolv ODT.

Applies to metoclopramide: oral solution, oral tablet, oral tablet disintegrating. Other dosage forms:

• nasal spray
• solution

Serious side effects of Metozolv ODT

Along with its needed effects, metoclopramide (the active ingredient contained in Metozolv ODT) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking metoclopramide:

Incidence not known

• Chills
• clay colored stools
• dark urine
• difficulty with breathing
• difficulty with speaking or swallowing
• dizziness or fainting
• fast or irregular heartbeat
• fever
• general feeling of tiredness or weakness
• headache (severe or continuing)
• inability to move the eyes
• increase in blood pressure
• increased sweating
• itching, skin rash
• lip smacking or puckering
• loss of appetite
• loss of balance control
• loss of bladder control
• mask-like face
• muscle spasms of the face, neck, and back
• nausea
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• seizures
• shuffling walk
• sore throat
• stiffness of the arms or legs
• stomach pain or tenderness
• swelling of the feet or lower legs
• tic-like or twitching movements
• trembling and shaking of the hands and fingers
• twisting movements of the body
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs
• unusually pale skin
• vomiting
• weakness of the arms and legs
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking metoclopramide:

Symptoms of overdose

• Confusion
• drowsiness (severe)

Other side effects of Metozolv ODT

Some side effects of metoclopramide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• drowsiness
• loss of strength or energy
• muscle pain or weakness
• restlessness
• unusual weak feeling

Incidence not known

• Breast tenderness and swelling
• changes in menstruation
• constipation
• decreased interest in sexual intercourse
• inability to have or keep an erection
• increased flow of breast milk
• increased need to urinate
• loss in sexual ability, desire, drive, or performance
• mental depression
• passing urine more often
• skin rash
• trouble sleeping
• unusual dryness of the mouth
• unusual irritability

For Healthcare Professionals

Applies to metoclopramide: compounding powder, injectable solution, nasal spray, oral concentrate, oral syrup, oral tablet, oral tablet disintegrating.

General

The incidence of side effects correlates with dose and duration of metoclopramide (the active ingredient contained in Metozolv ODT) therapy.^[Ref]

Nervous system

Drowsiness, decreased level of consciousness, confusion, and hallucinations have higher incidences with higher doses.

Convulsive seizures have been reported, especially in patients with epilepsy; however, there is no obvious association with use of this drug.

Dystonic reactions typically presented as upper airway obstruction with stridor and dyspnea.

Parkinsonian symptoms may be related to usual/excessive doses and/or decreased renal function and includes tremor, rigidity, bradykinesia, and akinesia.^[Ref]

Very common (10% or more): Drowsiness (up to 70%), acute dystonic reaction (up to 25%)

Common (1% to 10%): Akathisia, dizziness, extrapyramidal disorders, headache, parkinsonism, somnolence

Uncommon (0.1% to 1%): Depressed level of consciousness, dyskinesia, dystonia

Rare (0.01% to 0.1%): Bradykinesia, convulsion, dystonic reaction, tremor

Very rare (less than 0.01%): Neuroleptic malignant syndrome

Frequency not reported: Acute dyskinesia, acute dystonia/acute dystonic reaction, altered consciousness, autonomic instability, bulbar type of speech, choreoathetotic movements, cogwheel rigidity, convulsive seizures, extrapyramidal symptoms, facial grimacing, facial muscle spasm, fatal dystonic reaction, foot tapping, inability to sit still, involuntary movements of the extremities/face/jaw/mouth/tongue/trunk, mask-like facies, motor restlessness, opisthotonos, pacing, parkinsonian syndrome, rhythmic tongue protrusion, serotonin syndrome, syncope, tardive dyskinesia, tetanus-like reaction, unnatural position of head and shoulders^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, vomiting

Uncommon (0.1% to 1%): Bowel disturbances

Rare (0.01% to 0.1%): Supraglottic dystonia

Frequency not reported: Glossal edema^[Ref]

Other

Common (1% to 10%): Asthenia, fatigue, lassitude

Frequency not reported: Effects on the ability to drive/operate machinery, hyperpyrexia, hyperthemia, jitteriness^[Ref]

Psychiatric

Common (1% to 10%): Depression, restlessness

Uncommon (0.1% to 1%): Hallucination, insomnia

Rare (0.01% to 0.1%): Acute depression, confusional state

Frequency not reported: Agitation, anxiety, confusion, delirium, mania, mental depression with suicidal ideation, nervousness, obsessive rumination, severe dysphoria, suicidal ideation, suicide^[Ref]

Cardiovascular

Common (1% to 10%): Hypotension

Uncommon (0.1% to 1%): Bradycardia

Very rare (less than 0.01%): Cardiac conduction abnormalities, heart block

Frequency not reported: Acute congestive heart failure, acute hypertension, atrial fibrillation, atrioventricular (AV) block, cardiac arrest, edema, electrocardiogram QT prolonged, fatal cardiorespiratory arrest, hypertension, palpitation, possible AV block, shock, sinus arrest, supraventricular tachycardia, tachycardia, Torsade de Pointes, transient facial/upper body flushing, transient increase in blood pressure, ventricular fibrillation, ventricular tachycardia^[Ref]

Hypotension, bradycardia, shock, and other abnormalities or cardiac conduction occurred most frequently with IV formulations.

Cardiac arrest occurred shortly after IV administration, and may have been subsequent to bradycardia.

Sinus arrest and transient facial/upper body flushing occurred, particularly with IV administration. Flushing typically occurred without alterations in vital signs following high dose IVs.

Edema/fluid retention may be secondary to a transient increase in aldosterone levels.

Acute hypertension has occurred in patients with pheochromocytoma.

Hypertension has occurred in patients with/without pheochromocytoma.^[Ref]

Genitourinary

Impotence may be secondary to hyperprolactinemia.^[Ref]

Uncommon (0.1% to 1%): Amenorrhea

Rare (0.01% to 0.1%): Galactorrhea

Frequency not reported: Breast enlargement, impotence, priapism, sexual dysfunction, urinary frequency, urinary incontinence^[Ref]

Endocrine

Uncommon (0.1% to 1%): Hyperprolactinemia

Frequency not reported: Endocrine disorders, gynecomastia, transient aldosterone elevation^[Ref]

Amenorrhea, galactorrhea, and gynecomastia occurred secondary to hyperprolactinemia during prolonged treatment.^[Ref]

Hypersensitivity

Anaphylactic reaction/shock typically occurred with the IV formulation.^[Ref]

Uncommon (0.1% to 1%): Hypersensitivity

Frequency not reported: Anaphylactic reaction, anaphylactic shock, angioedema^[Ref]

Respiratory

Bronchospasm, wheezing, and dyspnea typically occurred in patients with a history of asthma.

Respiratory failure occurred secondary to dystonic reactions.^[Ref]

Rare (0.01% to 0.1%): Dyspnea, laryngospasm, stridor, upper airway obstruction

Frequency not reported: Acute asthmatic symptoms, bronchospasm, laryngeal edema, respiratory failure, wheezing^[Ref]

Hepatic

Rare (0.01% to 0.1%): Altered liver function tests, hepatotoxicity, jaundice^[Ref]

Hepatotoxicity occurred with concurrent use of other potentially hepatotoxic drugs and was characterized by findings such as jaundice and altered liver function tests.^[Ref]

Musculoskeletal

Rare (0.01% to 0.1%): Rigidity

Frequency not reported: Fluid retention, generalized muscle tone increase, increased creatinine phosphokinase (CPK), muscle rigidity, muscle spasms, torticollis, trismus^[Ref]

Hematologic

Frequency not reported: Agranulocytosis, blood disorders, leukopenia, methemoglobinemia, neutropenia, sulfhemoglobinemia^[Ref]

Leukopenia, neutropenia, and agranulocytosis typically did not have a clear-cut relationship with this drug.

Methemoglobinemia and sulfhemoglobinemia occurred with high doses of this drug. Methemoglobinemia may be related to NADH cytochrome b5 reductase deficiency or overdose, particularly in neonates. Sulfhemoglobinemia usually occurred in adults with concomitant use of high doses of sulfur-releasing products.^[Ref]

Dermatologic

Frequency not reported: Angioneurotic edema, maculopapular rash, rash, urticaria^[Ref]

Rash and urticaria typically occurred in patients with a history of asthma.^[Ref]

Ocular

Frequency not reported: Extraocular muscle spasm, oculogyric crisis, visual disturbances^[Ref]

Metabolic

Frequency not reported: Fluid retention, porphyria^[Ref]