Risperdal (risperidone) is an antipsychotic drug used to treat schizophrenia and bipolar disorder. It can also help reduce irritability in autistic patients.
While this drug has proven effective for many patients, it has been associated with a number of side effects, some of which can be serious and potentially fatal. Risperdal’s manufacturer, Janssen Pharmaceuticals, has faced several lawsuits relating to the drug’s side effects and marketing.
Uses of Risperdal
Risperdal is an antipsychotic drug that can be used to treat the symptoms of certain mental disorders. It can improve a patient’s mood, behavior, and thinking. The drug is prescribed primarily to treat schizophrenia and bipolar disorder (manic depression), but can also be used to relieve autism-related irritability in children.
In patients with schizophrenia, risperdal can help treat many common symptoms of the condition, including:
- A desire to be isolated from other people
- Incoherent speech
- Difficulty organizing or making sense of your thoughts
- Low motivation
For bipolar patients, Risperdal is a short-term treatment option for managing manic episodes, and may be taken along with valproate or lithium. In children with autism, the drug is commonly used to alleviate aggressive behavior toward others, temper tantrums, mood swings, and self-harming actions.
How Risperdal Works
In effect, Risperdal balances the brain’s activity by blocking its receptors for serotonin and dopamine. This contributes to clearer thinking, more regulated moods, and improved behavior. Risperdal comes in various forms, including tablets, an oral solution, long-acting injections, and orally disintegrating tablets.
When prescribed to treat schizophrenic adults, Risperdal should be taken once or twice daily. Most doses start at two milligrams (mg) per day, after which patients may slowly increase the dosage amount. Your doctor can advise you on the correct dose for you, but oral doses tend to be no more than six mg at a time.
Orally disintegrating tablets can be taken with or without water, since these will quickly dissolve in your mouth. If your doctor recommends administering Risperdal in the form of a long-acting injection, a fresh injection will be needed every two weeks.
While Risperdal has proven effective for treating schizophrenia, there is no known time frame for how long any patient should continue taking the drug. Your doctor should periodically assess whether the dosage needs to be increased or if you should stop taking the medication.
In its use as a short-term treatment method for bipolar disorder, Risperdal should be taken once daily at a starting dose of two or three mg. Patients generally feel Risperdal working within three weeks.
Side Effects of Risperdal
Both Risperdal and its generic form risperidone can sometimes cause side effects.
Since risperidone tends to increase a patient’s appetite, many children gain weight while on the drug, at an average of six pounds in eight weeks. Adults may also experience an increase in appetite while taking the drug. In rarer cases, this weight gain can lead to hyperglycemia or diabetes mellitus, with this risk being especially high among patients with obesity or a family history of diabetes.
Common Side Effects of Risperdal in Children and Adults
- Low blood pressure
- Increased heart rate
- Sexual dysfunction
While rare, taking risperidone can cause hormonal changes due to the increased amount of prolactin in the body. This can sometimes lead to sexual and menstrual problems, lactation in girls, and breast development in boys (gynecomastia).
In patients with dementia, Risperdal can cause strokes and transient ischemic attacks, which can be fatal. For this reason, the U.S. Food and Drug Administration (FDA) discourages the use of Risperdal or risperidone in treating elderly patients, specifically those aged 73 to 97.
Some patients taking Risperdal have developed extrapyramidal effects (EPS) and tardive dyskinesia (TD), conditions which often cause tremors, stiffness, restlessness, and uncontrollable muscle movements. These side effects are more likely in elderly patients, especially women.
Risperdal has also been known to lead to Neuroleptic Malignant Syndrome (NMS). NMS is a rare but potentially fatal reaction to Risperdal and similar antipsychotic drugs. Symptoms include rigid muscles, an impaired mental state, and an irregular pulse or irregular blood pressure. If you develop any of these symptoms, stop taking Risperdal immediately and seek medical attention.
Other possible Risperdal side effects include:
- Involuntary movements
- Increased cholesterol levels
- Increased blood sugar levels
- Disrupted body temperature
If you experience any severe side effects while taking risperidone, contact your doctor immediately.
Can Children Take Risperdal?
The FDA has approved Risperdal for children under certain circumstances. In autistic patients, Risperdal is approved for treating children aged five to 16. When used as a treatment for schizophrenia, teens aged between 13 and 17 can take the drug. As a treatment for bipolar disorder, Risperdal can be taken by children aged 10 to 17. Risperdal may not be safe for children outside these age ranges.
While Risperdal does not inherently “cure” autism, the drug has proven effective in many cases for reducing repetitive behavior, aggression, and hyperactivity. This can allow autistic children to more easily participate in everyday activities like school, therapy, and social interactions.
For children with autism, Risperdal treatment generally starts at a daily dosage of 0.5 mg. Depending on the drug’s effectiveness, this dosage may later be increased. The drug can be taken once a day, or the dose can be split in half and taken twice daily. The doctor may lower the dosage gradually when the patient shows signs of improvement, and will re-assess the treatment’s effectiveness and check for side effects.
For children with schizophrenia, Risperdal should be administered once daily at a starting dose of 0.5 mg per day. The highest recommended dose is four mg per day. At higher doses, children are more likely to experience negative side effects from the drug.
When treating bipolar disorder in children, Risperdal doses should begin at 0.5 mg, and should be taken once a day in either the morning or the evening. The recommended dose is 2.5 mg per day, with side effects being more likely above that dosage.
Due to the various side effects associated with Risperdal, doctors will typically put children on the lowest possible dosage of the drug and end treatment as soon as the child no longer needs it.
Around 2013, Risperdal manufacturer Janssen Pharmaceuticals faced lawsuits from 500 patients arguing that the drug had resulted in personal injuries. Eventually, this led to Johnson & Johnson (Janssen’s parent company) paying over $2.2 billion in response to claims that the company had marketed Risperdal and other drugs improperly.
In particular, Janssen faced claims that it had marketed Risperdal to children and the elderly without properly informing these patients of the risks associated with Risperdal use. To increase sales, the company had partnered with Omnicare to promote the use of Risperdal in nursing homes, leading to many Omnicare doctors prescribing the drug to their patients. Although the FDA did not approve Risperdal for elderly patients and noted that it could result in an increased risk of death, Janssen continued to promote the drug to these patients.
Janssen also faced claims that it had failed to warn patients of the risk of gynecomastia, or breast development in boys. In 2015, one of these cases resulted in a settlement amount of $2.5 million.