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Applies to metoclopramide: oral solution, oral tablet, oral tablet disintegrating
Other dosage forms:
Oral route (Tablet)
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. Discontinue metoclopramide 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 is stopped. Avoid treatment with Reglan for longer than 12 weeks because of the increased risk of developing TD with longer-term use.
Oral route (Tablet, Disintegrating; Solution)
Metoclopramide treatment can cause tardive dyskinesia, a serious movement disorder that is often irreversible. Risk is increased with duration of treatment and total cumulative dose. Discontinue metoclopramide therapy in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia, although symptoms may lessen or resolve after metoclopramide discontinuation. Prolonged treatment with metoclopramide (greater than 12 weeks) should be avoided in all but rare cases where therapeutic benefit outweighs the risks.
Along with its needed effects, metoclopramide 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
Get emergency help immediately if any of the following symptoms of overdose occur while taking metoclopramide:
Symptoms of overdose
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:
Incidence not known
For Healthcare Professionals
Applies to metoclopramide: compounding powder, injectable solution, oral concentrate, oral syrup, oral tablet, oral tablet disintegratingGeneral
The incidence of side effects correlates with dose and duration of metoclopramide therapy.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.
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 shouldersGastrointestinal
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 edemaOther
Common (1% to 10%): Asthenia, fatigue, lassitude
Frequency not reported: Effects on the ability to drive/operate machinery, hyperpyrexia, hyperthemia, jitterinessPsychiatric
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, suicideCardiovascular
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.
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 tachycardiaGenitourinary
Impotence may be secondary to hyperprolactinemia.
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 incontinenceEndocrine
Uncommon (0.1% to 1%): Hyperprolactinemia
Frequency not reported: Endocrine disorders, gynecomastia, transient aldosterone elevation
Amenorrhea, galactorrhea, and gynecomastia occurred secondary to hyperprolactinemia during prolonged treatment.Hypersensitivity
Anaphylactic reaction/shock typically occurred with the IV formulation.
Uncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Anaphylactic reaction, anaphylactic shock, angioedemaRespiratory
Rare (0.01% to 0.1%): Dyspnea, laryngospasm, stridor, upper airway obstruction
Frequency not reported: Acute asthmatic symptoms, bronchospasm, laryngeal edema, respiratory failure, wheezing
Bronchospasm, wheezing, and dyspnea typically occurred in patients with a history of asthma.
Respiratory failure occurred secondary to dystonic reactions.Hepatic
Hepatotoxicity occurred with concurrent use of other potentially hepatotoxic drugs and was characterized by findings such as jaundice and altered liver function tests.
Rare (0.01% to 0.1%): Altered liver function tests, hepatotoxicity, jaundiceMusculoskeletal
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, trismusHematologic
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.
Frequency not reported: Agranulocytosis, blood disorders, leukopenia, methemoglobinemia, neutropenia, sulfhemoglobinemiaDermatologic
Frequency not reported: Angioneurotic edema, maculopapular rash, rash, urticaria
Rash and urticaria typically occurred in patients with a history of asthma.Ocular
Frequency not reported: Extraocular muscle spasm, oculogyric crisis, visual disturbancesMetabolic
Frequency not reported: Fluid retention, porphyria
October 19, 2020
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