Drug Safety Information for ACTIQ (Fentanyl citrate)

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

Shared FDA Risk Evaluation and Mitigation Strategy

REMS for Actiq (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

Safety-related Labeling Changes for LAZANDA (FENTANYL CITRATE) Rx 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 ACTIQ (FENTANYL CITRATE) Rx 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

Adverse Drug Reactions for ACTIQ* (Fentanyl citrate)

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 ACTIQ
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain*2104
2Death1532
3Nausea*1510
4Vomiting1234
5Drug ineffective1101
6Product quality issue1049
7Anxiety1033
8Renal failure993
9Toxicity to various agents990
10Wrong technique in drug usage process956
11Hypotension953
12Somnolence*886
13Dyspnoea882
14Injury789
15Cardiac arrest723
16Drug interaction698
17Unevaluable event688
18Pyrexia670
19Diarrhoea667
20Overdose660

* This side effect also appears in "Top 10 Side Effects of ACTIQ " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ACTIQ
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Pain*12839
2Product used for unknown indication12437
3Back pain*3829
4Cancer pain2571
5Anaesthesia2212
6Breakthrough pain1331
7Analgesic therapy1329
8Induction of anaesthesia1036
9Sedation912
10Fibromyalgia*877

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ACTIQ

Total Reports Filed with FDA: 120358


Number of FDA Adverse Event Reports by Patient Age for ACTIQ

Total Reports Filed with FDA: 120358*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fentanyl citrate (Fentanyl buccal, Fentyl, Sublimaze, Lazanda, Fentora, Phentanyl, Fentanyl citrate, Onsolis, Fentanyl, Fentanilo, Abstral, Actiq)

Charts are based on 120358 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 ACTIQ 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 ACTIQ's side effects.