Reglan
Reglan treats digestive conditions and GERD. However, it comes with a risk of developing a movement disorder called tardive dyskinesia. The FDA now requires a black box warning on the medication, but many patients have sued manufacturers for failing to warn them about the risks.
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- Last update: September 2, 2025
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Reglan is the brand name of a drug called metoclopramide. It treats gastroesophageal reflux disease (GERD) and other digestive conditions that cause your intestinal tract to empty slowly.
Unfortunately, Reglan can cause a serious and often irreversible movement disorder called tardive dyskinesia (TD). This risk can increase depending on how long you take the medication and your dosage.
Some patients who developed TD after taking Reglan have filed lawsuits. If you’ve experienced adverse reactions to Reglan, consider talking to a lawyer to find out if you are eligible to take legal action.
What Is Reglan and Why Is It Prescribed?
Reglan is a medication used to treat certain digestive conditions. Its active ingredient is metoclopramide, which increases movements in your intestines and stomach.
- Chemotherapy-induced nausea and vomiting.
- GERD, which is when gastric acid flows backward into your esophagus and causes irritation.
- Slow stomach emptying, known as gatroparesis, in diabetic patients.
Reglan is available by prescription only. It comes in five or 10-milligram tablets.
Common and Serious Side Effects of Reglan
Like many medications, Reglan comes with risks. These can include common side effects, like headaches and nausea, or serious issues, including TD and depression.
Long-term use of Reglan can worsen your risk of developing side effects. The U.S. Food & Drug Administration (FDA) says that the drug should not be prescribed for longer than 12 weeks.
Common Side Effects
Reglan has many common side effects, including:
- Ankle, feet or hand swelling
- Difficulty sleeping
- Dizziness
- Drowsiness or fatigue
- Fever, irregular heartbeat or stiff muscles
- Headaches
- Higher-than-normal blood pressure
If you experience any side effects when taking Reglan, talk to your doctor.
Serious Risks
There are also serious risks associated with Reglan use.
- Depression and Suicidal Thoughts
- Reglan can cause you to have a worsened mood, feelings of depression and thoughts of self-harm or suicide.
- Neuroleptic Malignant Syndrome (NMS)
- NMS is a life-threatening but rare side effect that can result from taking Reglan. Symptoms include muscle stiffness and a high fever. Immediate emergency treatment is required because the condition can be fatal.
- Other Extrapyramidal Symptoms (EPS)
- EPS can have various symptoms, including an inability to remain still, involuntary muscle contractions and motor tics.
- Severe Allergic Reactions
- You may develop breathing and swallowing difficulties, facial swelling, hives, itching, mouth sores and skin rash or blisters while taking Reglan.
- Tardive Dyskinesia (TD)
- TD is a movement disorder that develops as a result of Reglan or certain other medications. It involves involuntary movements. The condition is generally not reversible, but there are treatments to try to manage the symptoms.
Reglan FDA Black Box Warning and Duration Limits
Reglan was approved by the FDA in 1979. The link between the medication and TD was discovered shortly after that. In 1985, the FDA required the Reglan label to be updated, alerting patients to the risk of developing TD.
Another label revision was issued by the FDA in 2009, focused on the length of Reglan use. The agency warned against taking the medication for more than 12 weeks. This black box warning is the highest safety-related warning that medications can have.
- “Reglan can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage.”
- “Discontinue Reglan in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after Reglan is stopped.”
- “Avoid treatment with Reglan for longer than 12 weeks because of the increased risk of developing TD with longer-term use."
In 2017, the FDA updated labeling to address dosage and usage, emphasize warnings about the TD risk and clarify other dangers, such as extrapyramidal symptoms.
Reglan Lawsuits
There have been many Reglan lawsuits. Plaintiffs allege that Reglan caused them to develop TD or other serious side effects. They also claim that drug manufacturers did not properly warn them about the risks associated with the medication.
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2009
Plaintiffs' attorneys in Reglan lawsuits requested the creation of a multidistrict litigation for claims that the medication caused TD. The request was denied since several of the cases were advanced and the actions didn’t share a single common defendant.
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2010
The New Jersey Supreme Court approved the consolidation of all Reglan lawsuits. All cases were moved before Superior Court Judge Carol E. Higbee. Reglan cases against Teva Pharmaceuticals were also consolidated in Philadelphia.
-
2011
The U.S. Supreme Court ruled that generic drug manufacturers couldn't be liable for failing to warn about the risks of generic Reglan because federal drug regulations prevented manufacturers of generic drugs from changing the label. The label must be the same as the label on the name-brand drug.
-
2014
The New Jersey lawsuits were transferred to Judge Jessica R. Mayer.
-
2018
Teva Pharmaceuticals and its subsidiaries reached a settlement to resolve pending Reglan lawsuits. The Philadelphia Court of Common Pleas accepted the settlement.
-
2021
The New Jersey cases were transferred to Judge Bruce Kaplan, who reported that all cases had been resolved.
Drugwatch’s legal partners are currently not accepting Reglan cases.
Who Is Most at Risk?
Reglan presents a risk to all patients, but the risk is higher depending on how long you use the drug, your age, whether you are a woman, or if you are diabetic.
- Patients with diabetes
- Female patients
- People taking Reglan for 12 weeks or longer
- Those over the age of 65
Anyone who is prescribed Reglan should be aware of the dangers, especially if they fall into any of these categories.
What Reglan Users Should Do Next
If you are using Reglan, watch for signs of side effects and speak with your doctor if you have concerns. Be sure to document your usage of the medication and any side effects your doctor verifies.
You should also avoid taking Reglan for longer than the recommended 12 weeks. Reach out to an attorney if you experience unexpected side effects to determine if you might be eligible to file a lawsuit.
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