Drug Safety Information for FENTANYL-100 (Fentanyl)

REMS for Actiq (FENTANYL CITRATE) Rx Drug: FDA Link

Shared FDA Risk Evaluation and Mitigation Strategy

REMS for FENTANYL (FENTANYL CITRATE) Rx Drug: FDA Link

Shared FDA Risk Evaluation and Mitigation Strategy

REMS for ABSTRAL (FENTANYL CITRATE) Discontinued Drug: FDA Link

Shared FDA Risk Evaluation and Mitigation Strategy

REMS for Subsys (FENTANYL) Rx Drug: FDA Link

Shared FDA Risk Evaluation and Mitigation Strategy

Safety-related Labeling Changes for LAZANDA (FENTANYL CITRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for SUBSYS (FENTANYL) Rx Drug: FDA Link

Safety-related Labeling Changes for ACTIQ (FENTANYL CITRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for IONSYS (FENTANYL HYDROCHLORIDE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for FENTORA (FENTANYL CITRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ONSOLIS (FENTANYL CITRATE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for ABSTRAL (FENTANYL CITRATE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for SUBLIMAZE PRESERVATIVE FREE (FENTANYL CITRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for FENTANYL CITRATE PRESERVATIVE FREE (FENTANYL CITRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for FENTANYL CITRATE (FENTANYL CITRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for DURAGESIC-100 (FENTANYL) Rx Drug: FDA 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
1Wrong technique in drug usage process6530
2Product quality issue5135
3Pain3785
4Drug ineffective3617
5Nausea*3018
6Vomiting2327
7Inappropriate schedule of drug administration2257
8Death2047
9Product adhesion issue1945
10Hyperhidrosis*1723
11Dyspnoea1708
12Toxicity to various agents1578
13Overdose1495
14Somnolence*1481
15Drug dose omission1478
16Dizziness*1441
17Fatigue*1389
18Fall1340
19Weight decreased1314
20Drug withdrawal syndrome1260

* 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
1Pain*43350
2Product used for unknown indication25022
3Back pain*13710
4Cancer pain3900
5Fibromyalgia*2936
6Arthralgia2426
7Neck pain1805
8Pain management1782
9Analgesic therapy1687
10Neuralgia*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 .

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.

Visit   DrugInformer.com more on FENTANYL-100's side effects.