Opioids are powerful medications that can help manage pain when prescribed for the right condition and when used properly. But when prescribed by physicians to patients who should not receive them, or when used improperly or for recreational purposes, they can cause serious harm, including overdose and death.
To report any serious adverse events associated with the use of these drugs, please contact the FDA MedWatch program using the contact information at the bottom of this page.
Information on Opioid Medications
- New Safety Measures Announced for Extended-release and Long-acting Opioids
- Naloxone Auto-Injector to Reverse Opioid Overdose
Addressing Prescription Drug Abuse in the United States, Current Activities and Future Opportunities
The FDA participated in the development of this report that reviews current federal initiatives and literature focused on ensuring the safe use of prescription drugs with the potential for abuse and the treatment of prescription drug dependence.
FDA Approves Zohydro ER and Responds to CLAAD Citizen Petition
Statement on Proposed Hydrocodone Reclassification from Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research
FDA Statement: Original Opana ER Relisting Determination
FDA Actions on OxyContin Products, 4/16/2013 Abuse-Deterrent Opioid Analgesics When Pain Relievers Cause Pain, Society Must React
FDA Voice Blog (4/3/2013)
- Attention Prescribers: FDA seeks your help in curtailing the U.S. opioid epidemic
FDA joins with health professional organizations in encouraging prescribers to seek training to safely prescribe opioid pain medicines
FDA Voice Blog (3/1/2013)
- Timeline of Significant FDA Activities Addressing Opioid Misuse and Abuse
(updated through 4/11/2014)
FDA’s Efforts to Address the Misuse and Abuse of Opioids
Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids FDA Works to Reduce Risk of Opioid Pain Relievers
FDA Consumer Update article