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Actiq Side Effects

Generic name: fentanyl

Medically reviewed by Drugs.com. Last updated on Jun 3, 2024.

Note: This document provides detailed information about Actiq Side Effects associated with fentanyl. Some dosage forms listed on this page may not apply specifically to the brand name Actiq.

Applies to fentanyl: transdermal patch extended release.

Other dosage forms:

Important warnings This medicine can cause some serious health issues

Transdermal route (patch, extended release)

Addiction, Abuse, and Misuse; Risk Evaluation and Mitigation Strategy (REMS); Life-threatening Respiratory Depression; Accidental Exposure; Neonatal Opioid Withdrawal Syndrome; Cytochrome P450 3A4 Interaction; Risk of Increased Fentanyl Absorption with Application of External Heat; and Risks From Concomitant Use of Benzodiazepines or Other CNS Depressants. Fentanyl exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.

Assess patient’s risk before prescribing, and monitor regularly for these behaviors or conditions.To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.Serious, life-threatening, or fatal respiratory depression may occur.

Monitor closely, especially upon initiation or following a dose increase.Accidental exposure to fentanyl, especially in children, can result in fatal overdose of fentanyl.Prolonged use of fentanyl during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.

If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl.Exposure of the fentanyl application site and surrounding area to direct external heat sources has resulted in fatal overdose of fentanyl.

Warn patients to avoid exposing the fentanyl application site and surrounding area to direct external heat sources.Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Transdermal route (patch, device assisted)

Warning: Life-Threatening Respiratory Depression; Ionsys REMS; Addiction, Abuse, and Misuse; Cytochrome P450 3A4 Interaction; and Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants. Serious, life-threatening, or fatal respiratory depression may occur.

Monitor closely, especially upon initiation.

Only the patient should activate dosing.Fentanyl iontophoretic transdermal system is for use only in patients in the hospital.

Discontinue fentanyl iontophoretic transdermal system before patients leave the hospital.Because of the risk of respiratory depression from accidental exposure, fentanyl iontophoretic transdermal system is available through a restricted program called the fentanyl iontophoretic transdermal system REMS Program.

Healthcare facilities that dispense fentanyl iontophoretic transdermal system must be certified in this program and comply with the REMS requirements.Fentanyl iontophoretic transdermal system exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.

Assess patient’s risk before prescribing, and monitor regularly for these behaviors and conditions.Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl.Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Common side effects of Actiq

Some side effects of fentanyl may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • constipation
  • feeling cold
  • sleepiness or unusual drowsiness
  • trouble sleeping

Less common

  • dry mouth
  • feeling of constant movement of self or surroundings
  • feeling of crawling, tingling, or burning of the skin
  • lack or loss of strength
  • memory loss
  • sensation of spinning
  • unusual dreams

Rare

  • abnormal ejaculation
  • decreased interest in sexual intercourse
  • decreased sexual performance or desire
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • muscle twitching

Incidence not known

  • belching
  • heartburn
  • indigestion
  • stomach discomfort or upset

Serious side effects of Actiq

Along with its needed effects, fentanyl (the active ingredient contained in Actiq) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fentanyl:

Less common

  • anxiety
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • confusion
  • decrease in urine volume
  • difficulty in breathing or swallowing
  • difficulty in passing urine (dribbling)
  • fast, irregular, pounding, or racing heartbeat or pulse
  • painful urination
  • rapid weight gain
  • seeing, hearing, or feeling things that are not there
  • skin itching, rash, or redness
  • swelling of the face, throat, or tongue
  • tremor
  • unusual weight gain or loss
  • upper stomach pain

Rare

  • bluish color of the fingernails, lips, skin, palms, or nail beds
  • burning, itching, redness, skin rash, swelling, or soreness at the application site
  • confusion about identity, place, and time
  • false or unusual sense of well-being
  • irregular, fast or slow, or shallow breathing

Incidence not known

  • agitation
  • blurred vision
  • chest pain or discomfort
  • cough
  • darkening of the skin
  • diarrhea
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fever
  • headache
  • hives
  • lightheadedness, dizziness, or fainting
  • loss of appetite
  • mental depression
  • nausea
  • nervousness
  • overactive reflexes
  • poor coordination
  • pounding in the ears
  • restlessness
  • severe constipation
  • severe vomiting
  • shivering
  • sweating
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting

Get emergency help immediately if any of the following symptoms of overdose occur while taking fentanyl:

Symptoms of overdose

For healthcare professionals

Applies to fentanyl: buccal film, buccal tablet, compounding powder, injectable solution, intravenous solution, nasal spray, oral lozenge, oral transmucosal lozenge, sublingual spray, sublingual tablet, transdermal device, transdermal film extended release.

General

The most commonly reported adverse reactions included headache, nausea, vomiting, ,dizziness, and constipation.[Ref]

Nervous system

Cases of seizures have occasionally been reported, but some investigators have suggested that the seizure-like events reported may have been episodes of fentanyl induced-rigidity.[Ref]

Cardiovascular

One report has suggested that epidural fentanyl may mask the pain of myocardial ischemia in patients treated with fentanyl for other reasons. Another report has suggested that QTc interval prolongation may occur in some patients receiving the related narcotic sufentanil. Another report has implicated fentanyl as a potential cause of pulsus alternans in a patient with aortic stenosis and congestive heart failure.

Nevertheless, fentanyl has been advocated by some as a satisfactory agent for coronary artery surgery.[Ref]

Gastrointestinal

Genitourinary

Dermatologic

Approximately 60% of patients had some redness at the skin site 24-hours after removal of the iontophoretic transdermal system. The majority of skin events were categorized as mild, erythema and papules were observed; 2 patients had hyperpigmentation at the application site lasting 2 to 3 weeks; 3 patients had a rectangular mark at the application site which persisted for up to 3 months.[Ref]

Hypersensitivity

Hematologic

The hemolysis observed may have been related to rapid injection of large volumes of hypotonic fentanyl (the active ingredient contained in Actiq) solution. The authors therefore recommend slower injection rates and/or mixture in isotonic fluid.[Ref]

Immunologic

Metabolic

Endocrine

Musculoskeletal

Ocular

Psychiatric

Respiratory

References

1. (2006) "Product Information. Ionsys (fentanyl)." Ortho McNeil Pharmaceutical

2. Sebel PS, Bovill JG (1983) "Fentanyl and convulsions." Anesth Analg, 62, p. 858-9

3. Rao TL, Mummaneni N, El-Etr AA (1982) "Convulsions: an unusual response to intravenous fentanyl administration." Anesth Analg, 61, p. 1020-1

4. Comstock MK, Carter JG, Moyers JR, Stevens WC (1981) "Rigidity and hypercarbia associated with high dose fentanyl induction of anesthesia." Anesth Analg, 60, p. 362-3

5. Weinger MB, Swerdlow NR, Millar WL (1988) "Acute postoperative delirium and extrapyramidal signs in a previously healthy parturient." Anesth Analg, 67, p. 291-5

6. Goroszeniuk T, Albin M, Jones RM (1986) "Generalized grand mal seizure after recovery from uncomplicated fentanyl-etomidate anesthesia." Anesth Analg, 65, p. 979-81

7. Steinberg RB, Gilman DE, Johnson F, 3d (1992) "Acute toxic delirium in a patient using transdermal fentanyl." Anesth Analg, 75, p. 1014-6

8. Eisenach JC (1991) "Respiratory depression following intrathecal opioids." Anesthesiology, 75, p. 712

9. Palmer CM (1991) "Early respiratory depression following intrathecal fentanyl-morphine combination." Anesthesiology, 74, p. 1153-5

10. Hoien AO (1984) "Another case of grand mal seizure after fentanyl administration." Anesthesiology, 60, p. 387-8

11. Safwat AM, Daniel D (1983) "Grand mal seizure after fentanyl administration." Anesthesiology, 59, p. 78

12. Crawford RD, Baskoff JD (1980) "Fentanyl-associated delirium in man." Anesthesiology, 53, p. 168-9

13. Smith NT, Benthuysen JL, Bickford RG, Sanford TJ, Blasco T, Duke PC, Head N, Dec-Silver H (1989) "Seizures during opioid anesthetic induction--are they opioid-induced rigidity?" Anesthesiology, 71, p. 852-62

14. Mirenda J, Tabatabai M, Wong K (1988) "Delayed and prolonged rigidity greater than 24 h following high-dose fentanyl anesthesia." Anesthesiology, 69, p. 624-5

15. Arandia HY, Patil VU (1987) "Glottic closure following large doses of fentanyl." Anesthesiology, 66, p. 574-5

16. Benthuysen JL, Stanley TH (1985) "Concerning the possible nature of reported fentanyl seizures." Anesthesiology, 62, p. 205

17. Streisand JB, Bailey PL, LeMaire L, Ashburn MA, Tarver SD, Varvel J, Stanley TH (1993) "Fentanyl-induced rigidity and unconsciousness in human volunteers. Incidence, duration, and plasma concentrations." Anesthesiology, 78, p. 629-34

18. Hays LR, Stillner V, Littrell R (1992) "Fentanyl dependence associated with oral ingestion." Anesthesiology, 77, p. 819-20

19. Brockway MS, Noble DW, Sharwood-Smith GH, McClure JH (1990) "Profound respiratory depression after extradural fentanyl." Br J Anaesth, 64, p. 243-5

20. Harper MH, Hickey RF, Cromwell TH, Linwood S (1976) "The magnitude and duration of respiratory depression produced by fentanyl and fentanyl plus droperidol in man." J Pharmacol Exp Ther, 199, p. 464-8

21. Varrassi G, Celleno D, Capogna G, et al. (1992) "Ventilatory effects of subarachnoid fentanyl in the elderly." Anaesthesia, 47, p. 558-62

22. Noble DW, Morrison LM, Brockway MS, Mcclure JH (1994) "Respiratory depression after extradural fentanyl." Br J Anaesth, 72, p. 251

23. Jackson FW (1994) "Fentanyl and the wooden chest." Gastroenterology, 106, p. 820-1

24. Sandler AN, Baxter AD, Katz J, Samson B, Friedlander M, Norman P, Koren G, Roger S, Hull K, Klein J (1994) "A double-blind, placebo-controlled trial of transdermal fentanyl after abdominal hysterectomy: analgesic, respiratory, and pharmacokinetic effects." Anesthesiology, 81, p. 1169-80

25. Bernstein KJ, Klausner MA (1994) "Potential dangers related to transdermal fentanyl (duragesic(r)) when used for postoperative pain." Dis Colon Rectum, 37, p. 1339-40

26. Gil-Gouveia R, Wilkinson PA, Kaube H (2004) "Severe hemiplegic migraine attack precipitated by fentanyl sedation for esophagogastroscopy." Neurology, 63, p. 2446-7

27. Cerner Multum, Inc. "UK Summary of Product Characteristics."

28. Hilgenberg JC, Johantgen WC (1980) "Bradycardia after intravenous fentanyl during subarachnoid anesthesia." Anesth Analg, 59, p. 162-3

29. Oden RV, Karagianes TG (1991) "Postoperative myocardial ischemia possibly masked by epidural fentanyl analgesia." Anesthesiology, 74, p. 941-3

30. Blair JR, Pruett JK, Crumrine RS, Balser JJ (1987) "Prolongation of QT interval in association with the administration of large doses of opiates." Anesthesiology, 67, p. 442-3

31. Sebel PS, Bovill JG, Boekhorst RA, Rog N (1982) "Cardiovascular effects of high-dose fentanyl anaesthesia." Acta Anaesthesiol Scand, 26, p. 308-15

32. Freeman AB, Steinbrook RA (1985) "Recurrence of pulsus alternans after fentanyl injection in a patient with aortic stenosis and congestive heart failure." Can Anaesth Soc J, 32, p. 654-7

33. McCammon RL, Viegas OJ, Stoelting RK, Dryden GE (1978) "Naloxone reversal of choledochoduodenal sphincter spasm associated with narcotic administration." Anesthesiology, 48, p. 437

34. Gaskey NJ, Ferriero L, Pournaras L, Seecof J (1986) "Use of fentanyl markedly increases nausea and vomiting in gynecological short stay patients." AANA J, 54, p. 309-11

35. Sosis M (1985) "Fentanyl and emesis." Can Anaesth Soc J, 32, p. 314-5

36. White MJ, Berghausen EJ, Dumont SW, Tsueda K, Schroeder JA, Vogel RL, Heine MF, Huang KC (1992) "Side effects during continuous epidural infusion of morphine and fentanyl." Can J Anaesth, 39, p. 576-82

37. Chin JL, Sharpe JR (1983) "Priapism and anesthesia: new considerations." J Urol, 130, p. 371

38. "Multum Information Services, Inc. Expert Review Panel"

39. Stoukides CA, Stegman M (1992) "Diffuse rash associated with transdermal fentanyl." Clin Pharm, 11, p. 222

40. Zucker-Pinchoff B, Ramanathan S (1989) "Anaphylactic reaction to epidural fentanyl." Anesthesiology, 71, p. 599-601

41. Bennett MJ, Anderson LK, McMillan JC, Ebertz JM, Hanifin JM, Hirshman CA (1986) "Anaphylactic reaction during anaesthesia associated with positive intradermal skin test to fentanyl." Can Anaesth Soc J, 33, p. 75-8

42. Furuya H, Okumura F (1986) "Hemolysis after administration of high-dose fentanyl." Anesth Analg, 65, p. 207-8

43. Valley MA, Bourke DL, McKenzie AM (1992) "Recurrence of thoracic and labial herpes simplex virus infection in a patient receiving epidural fentanyl." Anesthesiology, 76, p. 1056-7

44. Kokko H, Hall PD, Afrin LB (2002) "Fentanyl-associated syndrome of inappropriate antidiuretic hormone secretion." Pharmacotherapy, 22, p. 1188-92

45. Ananthanarayan C (1990) "Tussive effect of fentanyl." Anaesthesia, 45, p. 595

46. Bohrer H, Fleischer F, Werning P (1990) "Tussive effect of a fentanyl bolus administered through a central venous catheter." Anaesthesia, 45, p. 18-21

47. Soto J, Sacristan JA, Alsar MJ (1992) "Pulmonary oedema due to fentanyl?." Anaesthesia, 47, p. 913-4

48. Phua WT, Teh BT, Jong W, Lee TL, Tweed WA (1991) "Tussive effect of a fentanyl bolus." Can J Anaesth, 38, p. 330-4

49. Tweed WA, Dakin D (2001) "Explosive coughing after bolus fentanyl injection." Anesth Analg, 92, p. 1442-3

Frequently asked questions

Further information

Actiq side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.