Invega – Male Breast Side Effects, Drug Info & Settlements

Invega, a drug used to treat depression and anxiety in men is suspected of causing breast cancer. The FDA has issued warnings about Invega for the increased risk of developing breast cancer or other hormonal cancers.

Invega is a drug that has been prescribed for the treatment of male breast cancer. The side effects of this drug can include pain and swelling at the site of injection, as well as changes in skin pigmentation. In addition to these side effects, it can also cause nausea, vomiting, diarrhea and cramps.

Invega - Male Breast Side Effects, Drug Info & Settlements

Invega (paliperidone) is a close descendant of Risperdal (risperidone), an antipsychotic drug designed to treat schizophrenia and other mental disorders. Risperdal received FDA approval in 1994, under a Johnson & Johnson/Janssen Pharmaceuticals patent that expired in 2003.

Invega may lead to the development of feminine breast tissue in young males, a condition known as gynecomastia.

Invega, a generic equivalent of Risperdal, was created by Janssen in anticipation of Risperdal’s patent expiry (and a slew of rival generic copies of the medicine).

Unfortunately, both Invega and Risperdal may lead to the development of feminine breast tissue in young males, which is known as gynecomastia. Janssen never updated Invega labeling to include a warning about the risk of gynecomastia, which has resulted in a slew of Invega (and Risperdal) lawsuits from patients who developed gynecomastia or other adverse effects.

Hundreds of patients nationwide have filed lawsuits against J&J/Janssen, alleging that the company understood the gynecomastia risks but did not warn consumers adequately.

Invega’s Brief History

Janssen launched Invega, a near-identical medicine, a few years after the Risperdal patent expired in December 2003, to cushion the financial shock of fighting against generic versions of Risperdal.

Invega was licensed by the FDA in 2006 for the treatment of schizophrenia. The FDA amended the list of authorized uses in 2009 to include the treatment of schizoaffective disorder. Invega Sustenna, a long-acting, injectable version of Invega, was also authorized by the FDA that summer.

Invega Trinza, an extended-release variant of Invega, was authorized by the FDA in May 2015. For patients who have taken Invega Sustenna for at least four months, Trinza is a three-month injectable, “suspension-suitable” variant of Invega.

Invega’s Operation

Invega, like other antipsychotics, works by balancing the body’s natural hormones. It comes in three varieties:

  • Oral pill should be taken once a day
  • An injectable formulation with a longer release time (Invega Sustenna)
  • A newer injectable version with a longer duration of action (Invega Trinza)

Paliperidone (Invega) and risperidone (Risperdal) have chemical structures that are quite similar and, regrettably, have very comparable adverse effects. Risperidone’s main active metabolite is paliperidone. In other words, when the body breaks down Risperdal into its active chemical constituents, paliperidone is one among them.

Risperdal and Invega regulate patients’ emotions by adjusting hormones in the body such as dopamine and serotonin. Increases in the hormone prolactin, which drives breast development and milk production in women, have been linked to undesired side effects in males, including the growth of breast tissue, according to research (gynecomastia).

J&J Illegally Marketed Invega, Other Drugs

Johnson & Johnson paid a large settlement to the federal government in 2013 for illegally marketing Invega and other drugs. The government says that J&J made false and misleading statements about the safety and effectiveness of Invega, and promoted it for off-label uses.

J&J engaged in similarly questionable practices with Risperdal, which it marketed to children prior to FDA approval for that use, and despite research showing the drug could cause gynecomastia.


To maximize earnings, Janssen intended to broaden the popularity of its medications. According to Steven Brill of The Huffington Post, the firm engaged in misleading and illegal techniques for over a decade.

From 1999 to 2005, the FDA repeatedly warned J&J about promoting Risperdal for use by young people. During this time, the Justice Department says that Janssen promoted Risperdal for use in children and individuals with mental disabilities, despite knowing that Risperdal posed “certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development.” (In 2006, the FDA finally approved Risperdal for use by children and adolescents, specifically those suffering from autism.)

In 2012, Johnson & Johnson settled a Justice Department investigation into its promotion and marketing of Risperdal (and related state investigations, lawsuits, and probes) by paying a $2.2 billion fine, one of the largest in American pharmaceutical history.

But by then, the company had made nearly $30 billion (20 domestic, ten abroad) off the drug. Two billion dollars represented a tiny fraction of this profit—a slap on the wrist given all the kickbacks, unlawful marketing tactics, and data manipulation in which Johnson & Johnson engaged, to the detriment of consumers.

Risperdal and Invega are said to have caused hundreds, if not thousands, of boys to develop breasts. 

Invega has been linked to gynecomastia in studies.

Gynecomastia is caused by a hormonal imbalance, and it may result in the development of male breasts as well as considerable weight gain. Invega is thought to produce gynecomastia in young male users by increasing levels of prolactin, a hormone that encourages female breast growth and breastfeeding.

In at least two investigations, Invega has been related to gynecomastia:

  • Men who took risperidone or paliperidone had a 69 percent greater chance of developing gynecomastia than nonusers, according to research presented at the American Association for Geriatric Psychiatry (AAGP) Annual Meeting in 2014.
  • According to an FDA study of Invega side effects, 3% of patients receiving a daily dosage of paliperidone of 12 mg developed gynecomastia, including a 16-year-old male who developed signs barely two months after starting therapy.

Several studies have connected Risperdal (risperidone), Invega’s precursor and a close chemical related (if not twin) to an increased incidence of gynecomastia.

A 2006 research by a Duke psychiatrist showed a substantial link between Risperdal and gynecomastia in children and adolescents, which drew attention to the problem. When risperidone is given to teenagers for psychotic symptoms, the medicine raises prolactin levels and causes gynecomastia, according to the findings.

Janssen must be held accountable.

Another 2006 research on risperidone and gynecomastia came to the same result, stating that the drug should be used with care in young individuals.

A more recent research published in the Journal of Child and Adolescent Psychopharmacology concluded that risperidone usage and gynecomastia in young adult men are linked. Children and adolescents who used risperidone had a five-fold increased risk of gynecomastia as compared to non-users. Gynecomastia has a “severe psychological cost,” according to the research.

Thousands of lawsuits have been filed as a result of traumatic side effects.

Many young men who have suffered severe and lasting injury from Invega or Risperdal have filed lawsuits against Johnson & Johnson seeking compensation for physical injury, medical bills, financial losses, and pain and suffering. While each case is different, lawsuits involving Invega usually seek compensation for some combination of the following:

  • Anguish/pain and sorrow in the mind*
  • Medical costs in the present and future, including the cost of a mastectomy
  • Wages that have been lost
  • Damages for retaliation (an additional monetary award to the plaintiff to serve as punishment for the defendant)
  • Fees for lawyers

*Pain and suffering reimbursement covers the embarrassment and psychological anguish connected with breast enlargement as a result of using Invega.

Plaintiffs in the Risperdal case have been awarded millions of dollars by juries.

In November 2015, the Philadelphia Court of Common Pleas merged over 1,500 Risperdal gynecomastia cases as part of a mass tort. All of the claims claim that Risperdal induced gynecomastia in young males and that Janssen failed to warn users about the risk.

Invega victims may be eligible for large compensation, according to early Risperdal settlements:

  • In April 2015, a jury awarded $2.5 million in damages to a young man who got size 44D breasts after taking Risperdal. Janssen failed to adequately warn about Risperdal’s tendency to induce gynecomastia, according to the verdict.
  • In November 2015, a jury awarded $1.75 million to a man who acquired gynecomastia while using Risperdal for schizophrenia in 2003.

According to a Bloomberg News report, Janssen is dealing with around 5,400 Risperdal cases throughout the country (not all of which are connected to gynecomastia) and has put aside a significant sum to settle litigation.

In addition to Invega and Risperdal, Johnson & Johnson faces massive lawsuits over its talc-based powders, which have been linked to an increased risk of ovarian cancer.

We Can Assist

Our lawyers at assist customers in holding drug makers responsible for hazardous and faulty products. We’ve handled these issues for decades and have a proven track record of obtaining victims the recompense they deserve.

Our lawyers have assisted over 200,000 clients in receiving $5 billion in settlements and awards. Importantly, we do not need a retainer and only charge a fee if your matter is satisfactorily resolved.

Please contact us if you have had unanticipated adverse effects after using a drug. Don’t put it off; some instances are time-sensitive, and you might be eligible to compensation if you act quickly.

Invega is a drug that has been prescribed to men with breast cancer. The side effects of this drug include sexual dysfunction, and withdrawal symptoms. Settlements for the injuries caused by Invega are available in some cases. Reference: invega side effects, withdrawal.

Frequently Asked Questions

Can psych meds cause gynecomastia?

A: Yes, it can.

Is gynecomastia a side effect of antipsychotics?

A: Some people are prescribed antipsychotics as part of their treatment for schizophrenia, bipolar disorder, and other mental illnesses. Gynecomastia is a type of body-wide enlargement that can be caused by the use of these drugs. The more common side effects include weight gain, increased appetite and difficulty sleeping at night.

Does Invega cause swelling?

A: Invega is a type of medication that treats narcolepsy, obstructive sleep apnea, and some types of epilepsy. It does not cause swelling in any way.

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