[6] Common side effects include feeling tired, diarrhea, akathisia, and tardive dyskinesia.
[10][11] Metoclopramide is commonly used to treat nausea and vomiting associated with conditions such as uremia, radiation sickness, cancer and the effects of chemotherapy, labor, infection, and emetogenic drugs.
[14] The European Medicines Agency reviewed the drug's safety in 2011, which determined that it should not be prescribed in high doses, for periods of more than five days, or given to children below 1 year of age.
They suggested its use in older children should be restricted to treating post-chemotherapy or post-surgery nausea and vomiting, and even then only for patients where other treatments have failed.
[24] A large cohort study in Denmark found, in addition, no association between metoclopramide exposure and miscarriage.
[26] Common adverse drug reactions (ADRs) associated with metoclopramide therapy include restlessness (akathisia), and focal dystonia.
Infrequent ADRs include hypertension, hypotension, hyperprolactinaemia leading to galactorrhea, headache, and extrapyramidal effects such as oculogyric crisis.
[27] Consequently, the US Food and Drug Administration (FDA) recommends that metoclopramide be used for short-term treatment, preferably less than 12 weeks.
In 2009, the FDA required all manufacturers of metoclopramide to issue a black box warning regarding the risk of tardive dyskinesia with chronic or high-dose use of the drug.
[4] Agents in the benzodiazepine class of drugs may be helpful, but benefits are usually modest, and the side effects of sedation and weakness can be problematic.
[28] In some cases, the akathisia effects of metoclopramide are directly related to the infusion rate when the drug is administered intravenously.
The adverse symptoms oscillated between akinesian and akathisian, including amenorrhea, and appeared like secondary parkinsonism.
[30] Diabetes, age, and female gender are risk factors that increase the likelihood of experiencing a neuropsychiatric side effect of metoclopramide.
[35] Metoclopramide was first described by Louis Justin-Besançon and Charles Laville in 1964, while working to improve the anti-dysrhythmic properties of procainamide.
[54][56] In the early 1980s signs began to emerge in pharmacovigilance studies from Sweden that the drug was causing tardive dyskinesia in some patients.
may develop in patients treated with metoclopramide,” and warned against use longer than 12 weeks, as that was how long the drug has been tested.
[17][27] The emergence of this severe side effect led to a wave of product liability litigation against generic manufacturers as well as Wyeth.
[citation needed] Shortly following the Pliva decision, the FDA proposed a rule change that would allow generics manufacturers to update the label if the originating drug had been withdrawn from the market for reasons other than safety.