Risperdal (Risperidone) Drug Information

Risperdal, known generically as risperidone, is an atypical antipsychotic medication that has been approved by the U.S. Food & Drug Administration (FDA) to treat a number of psychiatric conditions, including:

  • Schizophrenia in adults and teenagers 13 years of age and older.
  • Episodes of mania or mixed episodes (simultaneous symptoms of mania and depression) in adults, teenagers, and children 10 years of age and older with bipolar disorder.
  • Behavior problems associated with autism in children ages 5 to 15.

risperdalRisperdal is what is known as a second-generation antipsychotic. This class of medications also includes Zyprexa, Seroquel and others. Unlike “typical” antipsychotics, “atypical” medications like Risperdal generally do not cause the same degree of movement side effects that are common with older drugs.

Risperdal comes in oral tablets, oral disintegrating tablets, and in an oral solution. The drug works by affecting dopamine and serotonin, neurotransmitters that impact mood and behavior. Risperdal is usually taken 1 or 2 times per day, either with or without food. Generally patients are started on a low dose of the medication, and dosage is increased slowly over several weeks.

History of Risperdal

Risperdal was approved by the FDA in 1993 to treat adult schizophrenia. Three years later, the number of Risperdal prescriptions had topped one million, making it one of the most popular psychiatric drugs in the U.S.

In 2003, the FDA expanded Risperdal’s approved uses to include bipolar disorder in adults. However, at that point, the drug was widely used in a range of off-label uses, including the treatment of elderly people with dementia, as well as children with autism and ADHD. By 2005, sales of Risperdal topped $2.5 billion in the U.S.

In 2006, the FDA approved Risperdal to treat irritability in autistic children and adolescents (ages 5 to 16). The following year, Risperdal was approved to treat schizophrenia in adolescents (ages 13 to 17), as well as bipolar disorder in children and adolescents (ages 10 to 17).

Risperdal Side Effects

Common Risperdal side effects may include sudden and involuntary motions of the head, neck, arms, body, or eyes, as well as dizziness, tiredness, fatigue, fever, and nausea. Weight gain, sleep problems, and stomach issues are also minor side effects that can accompany Risperdal use.

Risperdal can also increase the amount of prolactin in the blood. This hormone is related to breast development and lactation in girls and women, and high levels in men can lead to gynecomastia (excessive growth of breast tissue), loss of libido and erectile problems. In women, high prolactin levels can cause a disruption of menstruation and stimulate lactation. Long-term exposure to excessive prolactin is also linked to osteoporosis and bone fractures.

Side effects associated with long-term Risperdal use include a movement disorder called Tardive Dyskinesia, as well as an increased risk of diabetes, weight gain, and high cholesterol. The Risperdal label also bears a Black Box Warning regarding its association with an increased risk of death when used to treat elderly dementia patients.

Risperdal Legal Issues

Controversy over the way Risperdal was marketed, as well as some of its side effects, has caused a number of legal issues for the manufacturers of the drug. In November 2013, Johnson & Johnson and Janssen Pharmaceuticals reached a settlement agreement with the U.S. Department of Justice (DOJ) to resolve criminal and civil charges over the marketing of Risperdal and other medications. The $2.2 billion accord ranked among the largest healthcare fraud settlements in U.S. history. Among other things, the government had charged the companies with illegally promoting Risperdal for non-approved uses, including for use in elderly people with dementia. The Department of Justice also claimed that the drug makers marketed Risperdal for pediatric uses before those indications were approved by the FDA.

Risperdal has also been named in hundreds of product liability claims filed on behalf of people who allegedly suffered gynecomastia, diabetes and other side effects associated with its use.