risperidone: the legal and safety record

The settled record: the 2013 DOJ resolution

In November 2013, Johnson & Johnson and its subsidiary Janssen agreed to pay more than $2.2 billion to resolve criminal and civil investigations covering Risperdal and two other drugs [1]. The criminal piece is the part with a plea: Janssen pleaded guilty to a misdemeanor for misbranding Risperdal — promoting it to elderly patients with dementia, a use the FDA had not approved and had specifically flagged for mortality risk. The larger civil allegations — marketing to children and people with developmental disabilities before any pediatric approval existed, and payments to the nursing-home pharmacy Omnicare — were settled without a determination of liability, and precision about that distinction is the difference between reporting and insinuating.

The gynecomastia litigation: verdicts, reductions, settlements

Thousands of young men alleged Risperdal caused gynecomastia — breast tissue growth — and that the risk was understated to them and their prescribers. The number everyone remembers is the $8 billion punitive verdict a Philadelphia jury returned for one plaintiff in October 2019. The number almost nobody quotes with it: in January 2020 the court reduced that award to $6.8 million — a fact stated plainly in J&J’s own SEC filing [2]. Both numbers are the record. A page that gives you the first without the second is marketing, whichever side it is marketing for.

Beginning in 2021, the mass tort largely resolved in settlements whose terms are confidential. Media reports describe roughly 6,000 claims and totals around $1.1 billion [3]; we could not verify those figures in any filing, so this page reports them as reported — the order of magnitude is probably reliable, the digits are not checkable, and we say so rather than rounding confidence upward.

The underlying association does not rest on litigation: risperidone raises prolactin more than most antipsychotics and gynecomastia is on the label as a listed adverse reaction. It is also the single most-reported reaction for risperidone in the FDA’s public adverse-event data [5] — visible on our risperidone page with the reporting system’s limits stated above the counts, because litigation advertising demonstrably drives reporting and an honest page says that out loud.

What is not in the record

• No Class I recall. The openFDA enforcement database holds six risperidone recall records — four Class II, two Class III, all terminated, for manufacturing and labeling problems [4]. FDA’s most serious recall category has never been applied to this drug.
• No standing $8 billion judgment. The award that headlines most articles about this drug was reduced by three orders of magnitude within ninety days [2]. If a page quotes it without the reduction, read the rest of that page accordingly.

What this means if you take risperidone

Nothing on this page is a reason to change a dose on your own — stopping an antipsychotic abruptly carries real risks, and the marketing conduct settled in 2013 says nothing about whether the drug is right for you in 2026. What the record hands you is a fair question for your prescriber: risperidone’s prolactin effect is better documented than most side effects ever get — “is prolactin something we are monitoring, and what would we switch to if it became a problem?” That conversation is the entire practical content of a decade of litigation.

Common questions

Did Johnson & Johnson really get an $8 billion verdict over Risperdal?

Yes — a Philadelphia jury awarded $8 billion in punitive damages to one plaintiff in October 2019. And in January 2020 the court reduced it to $6.8 million, a fact J&J states in its own SEC filings. Both numbers are the record; quoting only the first is how this story is usually mis-told.

What did the Department of Justice case establish?

In November 2013, J&J and its subsidiary Janssen agreed to pay more than $2.2 billion to resolve criminal and civil investigations covering Risperdal, Invega and Natrecor. Janssen pleaded guilty to a misdemeanor for misbranding Risperdal — promoting it to elderly patients with dementia for uses the FDA had not approved. The civil allegations, including marketing to children and people with developmental disabilities and kickbacks to pharmacy provider Omnicare, were settled without a determination of liability.

What happened to the thousands of gynecomastia lawsuits?

Most were resolved in settlements beginning in 2021 whose terms are confidential. Media reports describe totals around $1.1 billion across roughly 6,000 claims; we could not verify those figures in any filing, so we report them as reported figures, not facts.

Is the gynecomastia risk itself real?

The association is on the FDA label — risperidone raises prolactin more than most antipsychotics, and gynecomastia is a listed adverse reaction. It is also the single most-reported reaction for risperidone in the FDA’s public adverse event database, which our risperidone page shows with the reporting system’s limits stated. Litigation likely inflates that reporting; the underlying association does not depend on it.

Has risperidone ever had a serious recall?

No Class I recall — FDA’s most serious category — appears in the openFDA enforcement database. Six records exist: four Class II and two Class III, all terminated, for manufacturing and labeling problems rather than anything about the molecule.

Sources

Last verified 2026-08-31. Corrections change this date.