Fentanyl transdermal Side Effects

Please note - some side effects for Fentanyl transdermal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

For the professional

Fentanyl Transdermal

In post-marketing experience, deaths from hypoventilation due to inappropriate use of Fentanyl Transdermal system have been reported.

Pre-marketing Clinical Trial Experience

Although Fentanyl Transdermal system use in post-operative or acute pain and in patients who are not opioid-tolerant is CONTRAINDICATED, the safety of Fentanyl Transdermal system was originally evaluated in 357 post-operative adult patients for 1 to 3 days and 153 cancer patients for a total of 510 patients. The duration of Fentanyl Transdermal system use varied in cancer patients; 56% of patients used Fentanyl Transdermal system for over 30 days, 28% continued treatment for more than 4 months, and 10% used Fentanyl Transdermal system for more than 1 year.

Hypoventilation was the most serious adverse reaction observed in 13 (4%) post-operative patients and in 3 (2%) of the cancer patients. Hypotension and hypertension were observed in 11 (3%) and 4 (1%) of the opioid-naïve patients.

Various adverse events were reported; a causal relationship to Fentanyl Transdermal system was not always determined. The frequencies presented here reflect the actual frequency of each adverse effect in patients who received Fentanyl Transdermal system. There has been no attempt to correct for a placebo effect, concomitant use of other opioids, or to subtract the frequencies reported by placebo-treated patients in controlled trials.

Adverse reactions reported in 153 cancer patients at a frequency of 1% or greater are presented in Table 1; similar reactions were seen in the 357 post-operative patients.

In the pediatric population, the safety of Fentanyl Transdermal system has been evaluated in 291 patients with chronic pain 2 to 18 years of age. The duration of Fentanyl Transdermal system use varied; 20% of pediatric patients were treated for ≤ 15 days; 46% for 16 to 30 days; 16% for 31 to 60 days; and 17% for at least 61 days. Twenty-five patients were treated with Fentanyl Transdermal system for at least 4 months and 9 patients for more than 9 months.

There was no apparent pediatric-specific risk associated with Fentanyl Transdermal system use in children as young as 2 years old when used as directed. The most common adverse events were fever (35%), vomiting (33%) , and nausea (24%).

Adverse events reported in pediatric patients at a rate of ≥ 1% are presented in Table 1.

The following adverse effects have been reported in less than 1% of the 510 adult post-operative and cancer patients studied:
Cardiovascular: bradycardia
Digestive: abdominal distention
Nervous: aphasia, hypertonia, vertigo, stupor, hypotonia, depersonalization, hostility
Respiratory: stertorous breathing, asthma, respiratory disorder
Skin and Appendages, General: exfoliative dermatitis, pustules
Special Senses: amblyopia
Urogenital: bladder pain, oliguria, urinary frequency

Post-Marketing Experience - Adults

The following adverse reactions have been reported in association with the use of Fentanyl Transdermal system and not reported in the pre-marketing adverse reactions section above:
Body as a Whole: Edema
Cardiovascular: tachycardia
Metabolic and Nutritional: weight loss
Special Senses: blurred vision
Urogenital: decreased libido, anorgasmia, ejaculatory difficulty

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