risperidone

Score breakdown (63/100)

Safety: 55

• Carries an FDA boxed warning, the strongest warning the FDA issues (-30)
• FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2011 (-8)
• 3,665 FDA reports naming it as the suspect drug per million Medicare fills, 1.3x the median drug on this site (-2)
• Death share in reports is near or below the FAERS average (0.7x)
• Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)

Evidence: 73

• 700 randomized trials and 77 systematic reviews/meta-analyses indexed in PubMed
• On the WHO Model List of Essential Medicines (shown for context; no score effect)
• 12 independent Cochrane review(s) exist
• Only 31% of completed registered trials posted results (-15)

Regulatory history: 87

• No recalls on record since 2016
• 20 label changes approved since 2021: the safety story is still moving (-8)
• Label lists recent major changes to warnings or indications (-5)

Money & lawsuits: 35

• Maker paid $2.2 billion in 2013 to settle federal allegations naming this drug (Off-label promotion, kickbacks) (-35)
• Pharma paid doctors $5,619,955 tied to this drug last year (-30)
• Not named in any pending federal MDL

Options: 70

• Generic versions approved (48 applications)
• No same-class alternatives found: little leverage to switch (-30)

Independent reviews and post-approval warnings

FDA Drug Safety Communications

• 06/2011 Risperdal and Requip - Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip)

Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.

WHO Essential Medicine

Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.

What the FDA label says

Approved uses

Risperidone is an atypical antipsychotic agent indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia Risperidone oral solution is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1) ]. 1.2 Bipolar Mania Monotherapy Risperidone oral solution is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2) ]. Adjunctive Therapy Risperidone oral solution adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studi...

Contraindications

Risperidone oral solution is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperidone oral solution formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone. Known hypersensitivity to risperidone, paliperidone, or to any excipients in risperidone oral solution. ( 4 )

Source: FDA SPL label for Risperidone (APOZEAL PHARMACEUTICALS INC), effective 20260830. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

Problems reported most often

Reports per year

3,665 reports blaming this drug for every million Medicare prescriptions filled, which is 1.3× the typical drug on this site. (13,971 reports in 2024–2026, against 3,811,919 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.

Evidence base

Independent Cochrane reviews

• Risperidone for psychosis-induced aggression or agitation (rapid tranquillisation) (2018)
• Risperidone versus other antipsychotics for people with severe mental illness and co-occurring substance misuse (2018)
• Risperidone versus placebo for schizophrenia (2016)
• WITHDRAWN: Risperidone versus other atypical antipsychotic medication for schizophrenia (2016)
• Risperidone (depot) for schizophrenia (2016)
• Risperidone versus other atypical antipsychotics for schizophrenia (2011)
• Risperidone versus placebo for schizophrenia (2010)
• Risperidone dose for schizophrenia (2009)
• Risperidone for attention-deficit hyperactivity disorder in people with intellectual disabilities (2009)
• Risperidone for autism spectrum disorder (2007)
• Risperidone in long-term treatment for bipolar disorder (2006)
• Risperidone versus olanzapine for schizophrenia (2006)

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $5,619,955 in payments to US physicians and hospitals tied to this drug across 51,079 transactions (Uzedy $5,373,811, Perseris $246,144).

No pending federal MDL names this drug or its brands.

Settlements of federal marketing and pricing allegations

• 2013 · Johnson & Johnson · $2.2 billion
  Off-label promotion, kickbacks Record

Settlements of $100M+ in which this drug (Risperdal) was a named product, as recorded by the Department of Justice. A settlement resolves allegations; civil settlements are not admissions and not findings of wrongdoing. They are shown because off-label promotion cases describe how the evidence many prescribers saw was shaped.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

Same-class alternatives

No same-class alternatives found in RxClass.

Questions to ask your prescriber

1. In 2011 the FDA issued a safety communication about this drug (Risperdal and Requip - Medication errors resulting from confusion between risperidone (Risperdal) and ropiniro). Does that risk apply to me?
2. The maker paid $2.2 billion in 2013 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?
3. This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
4. The most-reported problems in FDA's adverse event data are gynaecomastia, abnormal weight gain, weight increased. How would we recognize and handle those?
5. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
6. The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?
7. What result are we expecting, by when, and what is the plan if it does not happen?
8. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)