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 Actiq
Drug Substance/Generic Name fentanyl
Number of Patients Complaining 6,727
Serious Reactions to Substance 5,548
Non Serious Reactions to Substance 1,803
Substance Not Effective Complaints 403
At-Ray Ratio (NSR/SR); Safety indicator, higher is safer 0.32
PP Ratio (Patients Complaining/Not Effective), higher is more effective 16.69
Drug Rating = PP Ratio* At-Ray Ratio 3.61

Summary (from Wikipedia)




Indications and Usage (from FDA label)


1 INDICATIONS AND USAGE ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: •Not for use in opioid non-tolerant patients. •Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]. •As a part of the TIRF REMS Access program, ACTIQ may be dispensed only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required. ACTIQ is an opioid agonist indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids while taking ACTIQ. Limitations of Use •Not for use in opioid non-tolerant patients. •Not for use in the management of acute or postoperative pain, including headache/migraine or dental pain. (4) •As a part of the TIRF REMS Access program, ACTIQ may be dispensed only to outpatients enrolled in the program. (5.7) For inpatient administration of ACTIQ (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required.

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Drug Rating

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