🇺🇸 Paliperidone ER in United States

40 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Drug Ineffective — 6 reports (15%)
  2. Product Substitution Issue — 5 reports (12.5%)
  3. Treatment Noncompliance — 5 reports (12.5%)
  4. Aggression — 4 reports (10%)
  5. Akathisia — 4 reports (10%)
  6. Insomnia — 4 reports (10%)
  7. Extrapyramidal Disorder — 3 reports (7.5%)
  8. Nausea — 3 reports (7.5%)
  9. Psychotic Disorder — 3 reports (7.5%)
  10. Weight Increased — 3 reports (7.5%)

Source database →

Paliperidone ER in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Paliperidone ER approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Paliperidone ER in United States?

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the originator. The local marketing authorisation holder may differ — check the official source linked above.