Drug Safety Information for OXYMORPHONE HYDROCHLORIDE (Oxymorphone hydrochloride)
FDA Safety-related Labeling Changes for OPANA (OXYMORPHONE HYDROCHLORIDE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for OPANA ER (OXYMORPHONE HYDROCHLORIDE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for OPANA (OXYMORPHONE HYDROCHLORIDE) Rx Drug: Safety Information Link
Adverse Drug Reactions for OXYMORPHONE HYDROCHLORIDE* (Oxymorphone hydrochloride)
These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).
Top 20 Adverse Effects Associated with OXYMORPHONE HYDROCHLORIDE
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Drug abuse | 681 |
2 | Drug ineffective | 626 |
3 | Toxicity to various agents | 333 |
4 | Nausea* | 268 |
5 | Drug effect decreased | 250 |
6 | Wrong technique in drug usage process | 234 |
7 | Vomiting | 203 |
8 | Intentional drug misuse | 178 |
9 | Incorrect route of drug administration | 169 |
10 | Withdrawal syndrome | 158 |
11 | Malaise | 158 |
12 | Overdose | 151 |
13 | Death | 149 |
14 | Pain* | 144 |
15 | Headache | 137 |
16 | Feeling abnormal | 129 |
17 | Drug diversion | 129 |
18 | Completed suicide | 118 |
19 | Cardiac arrest | 117 |
20 | Diarrhoea | 115 |
* This side effect also appears in "Top 10 Side Effects of OXYMORPHONE HYDROCHLORIDE " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking OXYMORPHONE HYDROCHLORIDE
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Pain* | 3442 |
2 | Product used for unknown indication | 3344 |
3 | Drug abuse | 1050 |
4 | Back pain* | 748 |
5 | Breakthrough pain | 444 |
6 | Arthralgia | 138 |
7 | Pain in extremity | 112 |
8 | Fibromyalgia* | 107 |
9 | Neck pain | 91 |
10 | Drug diversion | 78 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for OXYMORPHONE HYDROCHLORIDE
Total Reports Filed with FDA: 14962
Number of FDA Adverse Event Reports by Patient Age for OXYMORPHONE HYDROCHLORIDE
Total Reports Filed with FDA: 14962*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Oxymorphone hydrochloride (Opanaer, Oxymorphone, Opana, Numorphan, Opana er)
Charts are based on 14962 reports filed with the FDA between 2004 and June 2015.
Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.
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Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.