Drug Landscape ›
Hydromorphone PCA ›
Regulatory · United States
Marketing authorisation
FDA
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.
Window: 20 April 2025 – 20 April 2026
Total reports: 17
Most-reported reactions
Mental Status Changes — 3 reports (17.65%) Disease Progression — 2 reports (11.76%) Drug Ineffective — 2 reports (11.76%) Dyspnoea — 2 reports (11.76%) Hospice Care — 2 reports (11.76%) Oxygen Saturation Decreased — 2 reports (11.76%) Abdominal Pain — 1 report (5.88%) Apnoea — 1 report (5.88%) Ataxia — 1 report (5.88%) Back Pain — 1 report (5.88%)
Source database →
Hydromorphone PCA 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 Hydromorphone PCA approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Hydromorphone PCA in United States?
M.D. Anderson Cancer Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.