Important Safety Information about METOZOLV® ODT
WARNING: TARDIVE DYSKINESIA
See full prescribing information for complete boxed warning.
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often
irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total
cumulative dose.
Metoclopramide therapy should be discontinued 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 treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where
therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
METOZOLV® ODT
(metoclopramide HCl) is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented
gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy and for the relief of symptoms
associated with acute and recurrent diabetic gastroparesis (diabetic gastric stasis) in adults. Therapy should not exceed
12 weeks in duration. Take on an empty stomach up to four times daily, at least 30 minutes before eating and at bedtime.
METOZOLV ODT is contraindicated in patients with intestinal obstruction, hemorrhage, or perforation;
pheochromocytoma; known sensitivity or intolerance to metoclopramide; epilepsy; or are receiving concomitant medications
with extrapyramidal reactions.
Extrapyramidal symptoms (EPS), manifested primarily as acute dystonic reactions, occur in approximately 1 in 500
patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first
24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than
30 years of age and are even more frequent at higher doses.
Drug-induced Parkinsonism can occur during metoclopramide therapy, more commonly within the first 6 months after
beginning treatment, but also after longer periods. Patients with a history of Parkinson’s disease should be given
metoclopramide cautiously, if at all, since such patients can experience exacerbation of Parkinsonian symptoms when taking
metoclopramide.
There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic
Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle
rigidity, altered consciousness, and evidence of autonomic instability. The management of NMS should include immediate
discontinuation of metoclopramide and other drugs not essential to concurrent therapy.
Depression associated with metoclopramide use has occurred in patients with and without a history of depression. For
those patients with a prior history of depression, metoclopramide should only be given if the expected benefits outweigh
the potential risks.
In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines;
hence, caution should be exercised when metoclopramide is used in patients with hypertension. Any rapid rise in blood
pressure associated with METOZOLV ODT use should result in immediate cessation of metoclopramide use in those patients.
Since metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart
failure may be at risk of developing fluid retention and volume overload. If these side effects occur at any time in any
patients during metoclopramide therapy, the drug should be discontinued.
Adverse reactions, especially those involving the nervous system, may occur after stopping the use of METOZOLV ODT.
In clinical studies, the most frequently reported adverse events (≥2% occurrence) were headache, nausea, fatigue,
somnolence, and vomiting.
Complete Prescribing Information for METOZOLV ODT, including BOXED WARNING
The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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