Fentanyl: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Fentanyl. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Nausea | 41% |
| Vomiting | 26% |
| Somnolence | 19% |
| Headache | 12% |
| Dizziness | 10% |
| Insomnia | 10% |
| Diarrhea | 10% |
| Constipation | 9% |
| Fatigue | 6% |
| Feeling cold | 6% |
| Hyperhidrosis | 6% |
| Anorexia | 5% |
| Palpitations | 4% |
| Malaise | 4% |
| Muscle spasms | 4% |
| Abdominal pain upper | 3% |
| Pruritus | 3% |
| Abdominal pain | 3% |
| Tremor | 3% |
| Anxiety | 3% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long- term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Medical disclaimer: Always consult a qualified healthcare professional about any medication.