Drug Safety Information for FENTANYL-100 (Fentanyl)
REMS for FENTANYL (FENTANYL CITRATE) Rx Drug: Safety Information Link
Shared FDA Risk Evaluation and Mitigation Strategy
REMS for Actiq (FENTANYL CITRATE) Rx Drug: Safety Information Link
Shared FDA Risk Evaluation and Mitigation Strategy
REMS for ABSTRAL (FENTANYL CITRATE) Discontinued Drug: Safety Information Link
Shared FDA Risk Evaluation and Mitigation Strategy
REMS for Subsys (FENTANYL) Rx Drug: Safety Information Link
Shared FDA Risk Evaluation and Mitigation Strategy
FDA Safety-related Labeling Changes for SUBSYS (FENTANYL) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for LAZANDA (FENTANYL CITRATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for ACTIQ (FENTANYL CITRATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for IONSYS (FENTANYL HYDROCHLORIDE) Discontinued Drug: Safety Information Link
FDA Safety-related Labeling Changes for FENTORA (FENTANYL CITRATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for ONSOLIS (FENTANYL CITRATE) Discontinued Drug: Safety Information Link
FDA Safety-related Labeling Changes for ABSTRAL (FENTANYL CITRATE) Discontinued Drug: Safety Information Link
FDA Safety-related Labeling Changes for SUBLIMAZE PRESERVATIVE FREE (FENTANYL CITRATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for FENTANYL CITRATE PRESERVATIVE FREE (FENTANYL CITRATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for FENTANYL CITRATE (FENTANYL CITRATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for DURAGESIC-100 (FENTANYL) Rx Drug: Safety Information Link
Adverse Drug Reactions for FENTANYL-100* (Fentanyl)
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 FENTANYL-100
(reported in FDA Medwatch/FAERS Reports)
| Side Effect | # of FDA Reports | |
|---|---|---|
| 1 | Wrong technique in drug usage process | 6530 |
| 2 | Product quality issue | 5135 |
| 3 | Pain | 3785 |
| 4 | Drug ineffective | 3617 |
| 5 | Nausea* | 3018 |
| 6 | Vomiting | 2327 |
| 7 | Inappropriate schedule of drug administration | 2257 |
| 8 | Death | 2047 |
| 9 | Product adhesion issue | 1945 |
| 10 | Hyperhidrosis* | 1723 |
| 11 | Dyspnoea | 1708 |
| 12 | Toxicity to various agents | 1578 |
| 13 | Overdose | 1495 |
| 14 | Somnolence* | 1481 |
| 15 | Drug dose omission | 1478 |
| 16 | Dizziness* | 1441 |
| 17 | Fatigue* | 1389 |
| 18 | Fall | 1340 |
| 19 | Weight decreased | 1314 |
| 20 | Drug withdrawal syndrome | 1260 |
* This side effect also appears in "Top 10 Side Effects of FENTANYL-100 " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking FENTANYL-100
(associated with FDA Medwatch/FAERS Reports)
| Reason | # of FDA Reports | |
|---|---|---|
| 1 | Pain* | 43350 |
| 2 | Product used for unknown indication | 25022 |
| 3 | Back pain* | 13710 |
| 4 | Cancer pain | 3900 |
| 5 | Fibromyalgia* | 2936 |
| 6 | Arthralgia | 2426 |
| 7 | Neck pain | 1805 |
| 8 | Pain management | 1782 |
| 9 | Analgesic therapy | 1687 |
| 10 | Neuralgia* | 1217 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for FENTANYL-100
Total Reports Filed with FDA: 208260
Number of FDA Adverse Event Reports by Patient Age for FENTANYL-100
Total Reports Filed with FDA: 208260*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fentanyl (Fentanest, Fentanyl-12, Fentanyl-50, Duragesic-25, Fentanyl-25, Fentanyl-87, Fentanyl-62, Fentanyl-37, Fentanyl - novaplus, Subsys, Duragesic-50, Duragesic, Fentanyl-75, Durogesic, Duragesic-75, Fentanyl-100, Duragesic-12, Duragesic-100)
Charts are based on 208260 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.
Click to go back to search results and FENTANYL-100 Reviews and Review Summary .
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.