Risperdal Side Effects

As of September 30, 2024, the Risperdal side effects most frequently reported to the FDA were enlarged breasts in men, abnormal weight gain and emotional disorders.

The FDA has classified over 57% of the adverse event reports it has received as serious side effects.

FAERS data represents all reported cases of adverse reactions observed in patients taking Risperdal. This data may not provide an accurate picture of the drug’s safety. You should discuss any concerns about possible side effects with your health care provider before taking a new medication.

Off-Label Use of Risperdal

Risperdal is an atypical antipsychotic used to treat schizophrenia, specific types of bipolar disorder and autism-associated irritability. However, doctors frequently prescribe Risperdal for attention-deficit/hyperactivity disorder, anxiety disorders, depression and sleep disorders, although it is not FDA-approved to treat these conditions.

This off-label use represents nearly 23% of the reported adverse effects received by the FDA. Because side effects can be serious, you should discuss the risks and benefits with your health care provider before using Risperdal for an unapproved condition.

Drowsiness, headaches, cold-like symptoms, gastrointestinal upset and increased prolactin production are among the most common Risperdal side effects, according to the latest prescribing information. Many of these symptoms are dose-dependent, with more severe symptoms reported among patients taking higher doses.

Many medication side effects will go away as your body adjusts to the drug, but this can take several weeks. However, some common side effects are serious and can be permanent.

Report any symptoms that become severe or last for more than a couple of weeks to your doctor. You may need to consider an alternative antipsychotic medication to manage your condition. Do not stop taking Risperdal unless instructed to by a health care professional.

Serious side effects associated with taking Risperdal include severe allergic reaction, gynecomastia, tardive dyskinesia, and in rare cases, death.

Although very rare, severe allergic reactions to Risperdal have occurred in a small number of patients. Severe allergies can cause anaphylaxis, a condition that may be fatal. Symptoms of anaphylaxis include swelling of the face, mouth, throat or eyes, difficulty breathing, whistling when breathing, hives, and pale, gray or flushed skin.

Packaging information warns against using the medication if you have a known allergy to risperidone, the active ingredient in Risperdal. Let your doctor know if you are allergic to risperidone or any other ingredients in the medication, as you may need to find an alternative.

Tardive Dyskinesia and Other Movement Disorders

Risperidone and other antipsychotic medications may cause neurological movement disorders and extrapyramidal symptoms, or EPS. However, Risperdal and similar atypical antipsychotics tend to be less closely associated with movement disorders than older medications.

When movement disorders do occur with Risperdal use, they can be distressing to patients. A review published in European Neuropsychopharmacology showed that patients taking oral risperidone were more likely to require antiparkinsonian medication than those taking other antipsychotics.

Some people may also misinterpret these neurological effects as psychotic symptoms, which may further stigmatize patients with psychiatric illnesses.

Tardive dyskinesia (TD) is a type of EPS that can occur with Risperdal use. The most common signs of TD include involuntary facial movements such as tongue clicking, lip smacking and cheek puffing. The condition can also cause jerky movements throughout the body.

TD can develop shortly after you start taking Risperdal, but symptoms are more likely to worsen and become permanent the longer you take the medication. Some symptoms may lessen or resolve on their own after you discontinue Risperdal, but in many cases, the symptoms become permanent even with early intervention.

Hyperprolactinemia and Gynecomastia

Hyperprolactinemia is one of the most common side effects of Risperdal. According to a 2024 analysis published in European Neuropsychopharmacology, risperidone produced higher prolactin levels compared to other drugs within the same class.

Some patients may not experience any symptoms from elevated prolactin levels, but many do. Higher levels of this peptide hormone can cause disturbances in menstrual cycles for women, decreased libido and impotence for men, low bone mass and a milky discharge from the nipples.

Increased prolactin production, which can cause enlarged breast tissue or gynecomastia in men, is a common and serious side effect of Risperdal. Gynecomastia can lead to social stigma and emotional distress. A 2022 review shows that hyperprolactinemia may occur in as many as 90% of patients taking Risperdal, although it’s less common in males. There are limited treatments available for the condition, and surgery may be the only option to reduce enlarged breasts caused by hyperprolactinemia.

Risk of Death

Older adults who use Risperdal for dementia-related psychosis face a 1.6 to 1.7 times greater risk of death than individuals not taking an antipsychotic. The medication packaging contains a boxed warning about this risk. According to that warning, most deaths have involved cardiovascular events or infection.

Risperdal Lawsuits

Multiple lawsuits alleged that Risperdal manufacturers Johnson & Johnson and Janssen Pharmaceuticals hid evidence of breast development and failed to adequately warn patients of this side effect. Some lawsuits also claimed the companies promoted off-label use of the drug.

Manufacturers settled the majority of remaining Risperdal lawsuits in 2021. Prior to that, some plaintiffs won jury awards, including one for $70 million, against the companies, which also paid several settlements.