Metoclopramide Side Effects

Some side effects of metoclopramide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to metoclopramide: oral syrup, oral tablet, oral tablet disintegrating

Get emergency medical help if you have any of these signs of an allergic reaction while taking metoclopramide: 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 of metoclopramide 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.

For Healthcare Professionals

Applies to metoclopramide: injectable solution, oral concentrate, oral syrup, oral tablet, oral tablet disintegrating

Nervous system

Tardive dyskinesia involves involuntary, dyskinetic, repetitive movements and may be more common in elderly women. Tardive dyskinesia may be irreversible and is related to both the duration of therapy and the total amount of drug consumed. Frequent discontinuation and resumption of therapy may predispose patients to the development of tardive dyskinesia.

Dystonias frequently involve tongue protrusions, muscle rigidity, torticollis, and opisthotonos. Dystonias usually resolve after metoclopramide discontinuation, but may require antihistamine and antiparkinsonian therapy if symptoms are severe or if respiration is compromised. Treatment of dystonic reactions and extrapyramidal effects, in addition to general supportive measures, may include judicious use of one or more of the following: benztropine or diphenhydramine.

Hyperthermia, altered consciousness, autonomic dysfunction, and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate of about 20%. Immediate discontinuation of metoclopramide therapy, consideration of dantrolene administration, as well as intensive monitoring and supportive care are indicated.

Drug-induced parkinsonian symptoms due to metoclopramide may be misdiagnosed and inappropriately treated with dopaminergic agents. Parkinsonian-like symptoms have occurred, more commonly within the first 6 months from the start of therapy with metoclopramide, but occasionally after longer periods. Caution should be exercised when diagnosing movement disorders in patients currently being treated with metoclopramide. Additionally, metoclopramide should be avoided in patients with confirmed Parkinson's disease.

Patients with AIDS or HIV-positive may be at an increased risk of developing acute dystonia to metoclopramide use. Decreases in dopamine levels have been observed in a study of AIDS patients without clinical neurologic disease. Similarly, HIV-positive patients have shown a decreased response in serum prolactin during intravenous infusion of metoclopramide when compared with controls, interpreted as an indirect evidence of a diminished endogenous dopamine tone.

Nervous system side effects have been commonly reported and included drowsiness, fatigue, restlessness, and lassitude in approximately 10% of patients. Drowsiness may occur in up to 70% of cancer patients treated with high-dose (1 to 2 mg/kg/dose) metoclopramide. Tardive dyskinesia, dystonia, pseudo-parkinsonism, and the neuroleptic malignant syndrome have also been reported. In addition, cases of akathisia have been reported. Seizures and hallucinations have been reported rarely. At least one case of lightheadedness has also been reported.

Endocrine

Endocrine side effects have included galactorrhea, amenorrhea, gynecomastia, and impotence secondary to hyperprolactinemia. In addition, metoclopramide may cause a transient increase in circulating aldosterone levels and subsequently cause edema.

Psychiatric

Depression may occur in patients without prior history of depression or other psychiatric illness and may be severe. Suicidal ideation may be present. Several reports suggest that dose reduction may alleviate depressive symptomatology. In addition, reintroduction of metoclopramide with slow titration of the dose upwards to a therapeutic level has been successful in some patients.

Psychiatric side effects have included depression, anxiety, mania, psychosis, and insomnia.

Cardiovascular

Cardiovascular side effects have included hypertension, hypotension, supraventricular tachycardia, bradycardia, and cardiac arrest. In addition, metoclopramide is associated with hypertensive crisis in patients with pheochromocytoma and has been implicated in a case of congestive heart failure.

It is postulated that metoclopramide may indirectly cause release of catecholamines from tumors in pheochromocytoma patients. Hypertensive crisis may ensue. The use of metoclopramide is considered contraindicated in patients with pheochromocytoma.

Hypertensive crisis has been documented in the absence of pheochromocytoma as well. The manufacturer recommends cautious use of metoclopramide in patients with essential hypertension.

Sinus bradycardia (50 beats per minute) progressing to complete heart block with sinus arrest has been reported in a 54-year-old man after receiving metoclopramide 10 mg IV. Asystole lasted approximately 25 seconds, followed by a spontaneous increase in heart rate to 80 beats per minute in sinus rhythm with a blood pressure of 140/70 mm Hg. Similar effects were observed on rechallenge with a dose of metoclopramide 5 mg given slowly. No changes in ST segment or QRS complexes were observed on electrocardiogram.

Hematologic

Patients with NADH-cytochrome b5 reductase deficiency who need to receive metoclopramide are at increased risk of developing methemoglobinemia and/or sulfhemoglobinemia. The treatment of metoclopramide-induced methemoglobinemia with methylene blue is not recommended in patients with G6PD deficiency.

Hematologic side effects including leukopenia, neutropenia, porphyria, and agranulocytosis have been reported rarely. Methemoglobinemia has also been reported with metoclopramide use in adults, but may be more common in infants who are treated with high doses.

Hepatic

A 22-year-old female, treated with metoclopramide 10 to 15 mg per day for 7 to 8 months for abdominal pain, developed hepatic hemangiomatosis with arteriovenous shunting and cholestasis. Hyperprolactinemia, galactorrhea, amenorrhea, and virilization were also noted on initial presentation. The patient was placed on a waiting list for liver transplantation. However, complete, albeit slow, resolution occurred following discontinuation of metoclopramide.

Hepatic side effects have included rare reports of elevations in liver function tests and jaundice. A case of arteriovenous shunting and cholestasis in conjunction with hepatic hemangiomatosis has been reported.

Genitourinary

Genitourinary side effects have included urinary frequency, incontinence, and urinary retention.

Hypersensitivity

Hypersensitivity side effects have included rash, urticaria, bronchospasm, angioneurotic edema, and glossal or laryngoedemal reactions.

Gastrointestinal

Gastrointestinal side effects have included nausea and diarrhea.

Respiratory

Respiratory side effects have been reported rarely. A case of metoclopramide-induced bronchospasm is reported in the literature.

Other

Other side effects have included porphyria, local pain during intravenous injection, and transient flushing during high-dose infusion. At least one case of generalized weakness has been reported.

Renal

Renal side effects have included urinary frequency and incontinence.

Ocular

Ocular side effects have included visual disturbances. Decrease in pupil diameter and transiently depressed reflex dilation have been reported in patients undergoing lower abdominal surgery under combined epidural/general anesthesia.

Musculoskeletal

Musculoskeletal side effects have included a case of dystonic reaction.

A 28-year-old female experienced dystonic reaction coincident with metoclopramide therapy. She had started taking metoclopramide the day before her presentation to the hospital. Her symptoms resolved six to eight hours after onset.

General

In general, the incidence of side effects correlates with dose and duration of metoclopramide therapy. The elderly may be more susceptible to developing adverse effects due to the changes in organ function, concomitant diseases, and other drug therapies.

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