Most frequent complaints reported(multiple complaints per patient are possible)

Adverse effect may be due to disease and/or other underlying condition and medication/treatment may not be causative factor




DRUG RATING DETAILS (RANK BASED ON RATINGS OF SIMILAR DRUGS; SEE TABLE AT BOTTOM)


Drug Brand Name Abstral
Drug Substance/Generic Name fentanyl
Number of Patients Complaining 35,370
Serious Reactions to Substance 30,329
Non Serious Reactions to Substance 7,466
Substance Not Effective Complaints 1,893
At-Ray Ratio (NSR/SR); Safety indicator, higher is safer 0.25
PP Ratio (Patients Complaining/Not Effective), higher is more effective 18.68
Drug Rating = PP Ratio* At-Ray Ratio 3.08

Summary (from Wikipedia)




Indications and Usage (from FDA label)


1 INDICATIONS AND USAGE ABSTRAL (fentanyl) sublingual tablets are indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid medication daily for a week or longer. Patients must remain on around-the-clock opioids when taking ABSTRAL. ABSTRAL is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could result at any dose in patients not on a chronic regimen of opioids. For this reason, ABSTRAL is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. ABSTRAL is intended to be prescribed only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain. Limitations of Use: As a part of the TIRF REMS Access program, ABSTRAL may be dispensed only to outpatients enrolled in the program [see Warnings and Precautions (5.10)]. For inpatient administration of ABSTRAL (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required. ABSTRAL is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. (1) Limitations of Use: ABSTRAL may be dispensed only to patients enrolled in the TIRF REMS Access program.

Copyright for images below belongs to manufacturer mentioned in label, presented for information only


Opioid anesthetics,Phenylpiperidine derivatives
(9) Similar Drugs to Abstral ; Comparison Table Below
(Best drugs have high rating/ranking,high safety ratio and high effectivity ratio)
Brand Name (Click for details) Active Ingredient Drug ATC Class Price Found (US $) OVERALL
Drug Rating

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