Reglan Side Effects

As of June 30, 2024, movement disorders such as tardive dyskinesia and dystonia were the most common Reglan (metoclopramide) side effects reported to the U.S. Food and Drug Administration.

These are potentially serious neurological conditions that can lead to permanent disability. The FDA ranked almost all reported side effects as serious.

Over half of the adverse reaction cases reported to the FDA occurred in 2011 and 2012.

Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.

Some side effects, especially dizziness and headache, are more likely to occur as a withdrawal reaction. Patients, especially those at increased risk of developing serious side effects, should discuss the risks and benefits of Reglan with a health care provider before taking it.

FDA Boxed Warning

The FDA issued a statement in February 2009 requiring a boxed warning on all Reglan packaging. The warning advises of the risk of developing tardive dyskinesia and the increased risk associated with extended use.

Because risks increase with long-term Reglan use, the warning advises doctors to limit treatment to 12 weeks or less. Doctors may choose to prescribe Reglan for extended durations in circumstances where the benefits directly outweigh the risks.

Prescribing information indicates that drowsiness, fatigue, lassitude (weariness or lack of energy) and restlessness occurred in approximately 10% of patients taking 10 mg of Reglan four times daily. Confusion, dizziness, depression, headache, insomnia and suicidal ideation occurred less frequently than other side effects.

Tardive dyskinesia (TD) is another common side effect. It causes involuntary muscle movements and is sometimes permanent.

Side effects tend to increase with dosage strength and duration and most often occur shortly after stopping Reglan.

Most common side effects are mild and resolve within a few days. However, because some side effects such as TD may be permanent, you should report severe or persistent symptoms to your care provider. If you notice unusual muscle or facial movements, notify your doctor immediately.

Tardive dyskinesia is the most common serious Reglan side effect, along with other movement disorders, fluid retention and increased prolactin levels.

Most severe side effects from Reglan are rare, but some can cause permanent damage or death. Neuroleptic malignant syndrome, which causes a high fever and muscle stiffness, can lead to organ damage if left untreated. Increased prolactin levels can cause infertility and decreased sex drive, although it’s usually treatable and not life-threatening.

Reglan may also affect your mental and physical ability to operate a motor vehicle or heavy machinery. This can be made worse by certain antidepressants and other medications that can cause body movement disruptions, such as narcotics and sedatives.

Tardive Dyskinesia

Tardive dyskinesia is a neurological condition that can occur while taking Reglan. It is a serious potential side effect that prompted an FDA boxed warning. Patients who are over 65, assigned female at birth or have diabetes are at an elevated risk of developing TD.

There is a direct link between dopamine receptor antagonists like Reglan and tardive dyskinesia. Earlier research, including a 1993 study published in the Archives of Internal Medicine, suggested that between 1% and 10% of patients using Reglan developed TD. However, newer research published in the Journal of Neurogastroenterology and Motility indicates that the actual risk is much lower, with estimates at or below .1%.

TD causes involuntary movements and most commonly affects facial muscles. Symptoms include grimacing, jaw swinging, lip smacking, repetitive chewing, rapid eye blinking and tongue thrusting. It can also cause involuntary finger movements and rocking of the pelvis.

Symptoms may subside once you stop Reglan if your doctor diagnoses TD early. Treatments include dopamine-depleting medicines such as tetrabenazine and valbenazine, which may resolve mild symptoms. Deep brain stimulation, a surgical procedure on the brain that uses electrical stimulation, may help relieve symptoms in

Involuntary movements from tardive dyskinesia may become permanent even after stopping your medication and undergoing treatment.

Tardive Dyskinesia Lawsuits

Patients who suffered permanent neurological damage, including from TD, filed lawsuits to hold drug manufacturers accountable. They claim companies failed to adequately disclose the risks and that doctors prescribed Reglan for prolonged periods despite known risks. Many cases have reached a resolution in court or through settlements, and most lawyers are not taking new Reglan lawsuits.

It is important to seek medical attention as soon as possible if you suspect tardive dyskinesia or experience other movement disorder symptoms. Early medical intervention may help reduce the severity of symptoms and improve treatment outcomes.

You should also call your doctor if you notice signs of an allergic reaction, such as rash, hives or difficulty breathing or swallowing. High-pitched sounds while breathing and swelling of the face, tongue, lips or eyes could indicate a serious allergic reaction that could lead to anaphylaxis.

Editor Lindsay Donaldson contributed to this article.