Risperdal Side Effects, FDA Warnings & Lawsuits
Risperdal, an antipsychotic drug, has been linked to serious risks, including gynecomastia, movement disorders and death in elderly dementia patients. Learn about side effects, FDA warnings and the lawsuits alleging Johnson & Johnson failed to warn patients of serious risks.
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- Last update: September 18, 2025
- Est. Read Time: 3 min read
- Risperdal (risperidone) has been used as an antipsychotic since the early 1990s.
- The drug has been linked to significant health issues, such as male breast development, movement disorders and an increased risk of death for elderly dementia patients.
- The FDA has issued strong warnings, and legal actions have resulted in billions in settlements and verdicts.
What Is Risperdal and Why Are There Lawsuits?
Risperdal (risperidone) is prescribed for schizophrenia, acute manic or mixed episodes related to bipolar disorder, and irritability from autism. It has also been used off-label for several other disorders, such as borderline personality disorder, PTSD, brain injuries and Tourette syndrome, among others. Some patients have pursued legal action after experiencing serious side effects.
These lawsuits claim that the manufacturer, Johnson & Johnson, failed to warn the public about the potential risks and promoted the drug for unapproved, off-label uses. Janssen Pharmaceuticals Inc., Patriot Pharmaceuticals Inc. and Janssen Research and Development have also been named in these lawsuits.
Common and Serious Risperdal Side Effects
Some of the common side effects of taking Risperdal include:
- Anxiety
- Blurred vision
- Cold-like symptoms
- Dizziness
- Drowsiness
- Dry mouth
- Gastrointestinal issues or discomfort
- Inability to remain still (akathisia)
- Parkinsonism
- Restlessness or insomnia
- Weight gain
Some of the more serious side effects of taking this drug include:
- Cognitive and motor impairment
- Judgment, thinking and motor skills may all be impacted, especially when taking higher doses of Risperdal. Some patients should avoid driving and other activities that require concentration when taking certain doses.
- Decline in white blood cell count (leukopenia, neutropenia and agranulocytosis)
- Patients with a history of low white blood cell count should be monitored closely while taking Risperdal.
- Dysphagia
- The esophagus struggles to move food, which could increase the risk of aspiration.
- Gynecomastia
- This is the development of male breast tissue, and it often occurs in younger males and could require surgery.
- Hyperprolactinemia
- In addition to gynecomastia, this includes hormonal issues related to lactation, reproduction, sex drive and bone mass.
- Increased risk of death in elderly patients with dementia
- Antipsychotic usage in these patients has been linked with a marked increase in the risk of death.
- Metabolic changes
- Some people have reported weight gain, hyperglycemia and high cholesterol.
- Neuroleptic Malignant Syndrome
- This rare but life-threatening syndrome manifests as a dangerously high fever (hyperpyrexia), rigid muscles, delirium, irregular pulse and several other concerning signs.
- Prolonged erection (priapism)
- This condition, in which the penis remains erect for four or more hours, may require surgical intervention.
- Seizures
- Testing in patients with schizophrenia showed that those with a history of seizures should be cautious about using Risperdal.
- Tardive dyskinesia
- This can cause involuntary movements that could become permanent.
FDA Warnings and Regulatory Actions
After an initial warning about Risperdal’s effects on elderly patients with dementia in 2003, the FDA added a black box warning to the Risperdal label in 2005. This warning states that elderly patients with dementia-related psychosis who are treated with antipsychotics like Risperdal can face an increased risk of death. The combination of Risperdal and furosemide might be particularly dangerous. Because of these risks, Risperdal is not recommended for elderly patients with dementia-related psychosis.
This drug’s label also includes risks like gynecomastia, metabolic issues like diabetes and elevated prolactin levels, which can cause breast development.
In 2013, the U.S. Department of Justice found that Johnson & Johnson had illegally marketed the drug for unapproved uses, especially in children and those with dementia, between 1999 and 2005. The company failed to disclose safety issues and agreed to pay over $2.2 billion. This included $485 million in criminal fines, as well as $1.72 billion in civil settlements.
Scientific Evidence Linking Risperdal to Harm
A long-term study published in 2015 showed adolescent males who were on Risperdal were up to five times more likely to develop breast tissue than those who weren’t taking the drug. Elevated prolactin levels, which are a known side effect of this drug, are linked to the condition, called gynecomastia.
FDA safety communications also showed that elderly dementia patients who were on Risperdal had a higher risk of death and a heightened risk of strokes. An analysis of 17 placebo-controlled trials supported these communications.
Legal Basis for Risperdal Lawsuits
Plaintiffs in the Risperdal lawsuits claim that Johnson & Johnson:
- Failed to warn of the known risks adequately, such as gynecomastia in minors and the increased death risk in elderly dementia patients.
- Used deceptive marketing that promoted off-label use.
- Acted negligently by concealing relevant study results and downplaying the potential risks.
A few of the verdicts and settlements as a result of these lawsuits include:
- $2.5 million was awarded to Austin Pledger in 2015, which marked the first major jury trial victory.
- $70 million was awarded to Andrew Yount, a teen who had been prescribed Risperdal at a very young age, in 2016. That verdict was later upheld.
- $1 million was awarded to Shaquil Byrd, but this was later overturned.
- $1.75 million was awarded to Nicholas Murray. He was then granted $8 billion in punitive damages in 2019, which was reduced to $6.8 million in 2020. Both sides said they plan to appeal.
In October 2021, Johnson & Johnson had settled most of the roughly 9,000 remaining cases. The company recorded $800 million in settlement expenses. It also previously paid $181 million to settle state claims over off-label marketing before the larger DOJ settlement.
Who May Qualify for a Risperdal Lawsuit?
People who may be eligible for a Risperdal lawsuit include those who:
- Developed gynecomastia after using Risperdal.
- Suffered severe movement disorders or strokes associated with the drug.
- Lost a loved one after they used Risperdal for dementia-related psychosis.
These individuals could have legal grounds to pursue compensation for medical costs, emotional harm and punitive damages.
Next Steps if You’ve Experienced Side Effects
If you’ve experienced any side effects, you should take these steps:
- Document symptoms and medical history: You should keep detailed records of Risperdal usage, the onset of symptoms, medical treatments and any emotional or psychological impacts.
- Consult a physician: A healthcare provider can decide whether your symptoms are related to Risperdal usage.
- Contact a Mass Tort Attorney: A qualified lawyer can review your case for potential legal action. They can help you understand your eligibility and how to pursue compensation.
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