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Duragesic

Last reviewed on RxList: 5/5/2020
Duragesic Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Duragesic?

Duragesic (fentanyl) Transdermal System for transdermal administration is an opioid analgesic 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. Duragesic (fentanyl) Transdermal System is available in generic form.

What Are Side Effects of Duragesic?

Common side effects of Duragesic (fentanyl) Transdermal System include:

Dosage for Duragesic

Duragesic (fentanyl) Transdermal System is available in doses of 12 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, and 100 mcg/hr.

What Drugs, Substances, or Supplements Interact with Duragesic?

Duragesic (fentanyl) Transdermal System may interact with other CNS depressants (including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol), CYP3A4 inhibitors or inducers, monoamine oxidase (MAO) inhibitors, pentazocine, nalbuphine, butorphanol, buprenorphine, and anticholinergics. Tell your doctor all medications and supplements you use. Duragesic (fentanyl) Transdermal System is not recommended for use during pregnancy; it may harm a fetus.

Duragesic During Pregnancy and Breastfeeding

Duragesic (fentanyl) Transdermal System passes into breast milk and may cause undesirable side effects in a nursing infant. Breastfeeding is not recommended while using Duragesic (fentanyl) Transdermal System. Withdrawal symptoms may occur if you suddenly stop taking Duragesic (fentanyl) Transdermal System.

Additional Information

Our Duragesic (fentanyl) Transdermal System for transdermal administration Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Duragesic Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Remove the skin patch and call your doctor at once if you have:

  • slow heart rate, sighing, weak or shallow breathing (up to several days after removing the skin patch);
  • breathing that stops during sleep;
  • confusion, severe drowsiness, feeling like you might pass out;
  • chest pain, fast or pounding heartbeats; or
  • low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common side effects may include:

  • headache, dizziness, drowsiness, tiredness;
  • nausea, vomiting, stomach pain, diarrhea, constipation;
  • itching, redness, or rash where a patch was worn;
  • sleep problems (insomnia); or
  • increased sweating, or cold feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Duragesic (Fentanyl Transdermal)

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Duragesic Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trial Experience

The safety of DURAGESIC was evaluated in 216 patients who took at least one dose of DURAGESIC in a multicenter, double-blind, randomized, placebo-controlled clinical trial of DURAGESIC. This trial examined patients over 40 years of age with severe pain induced by osteoarthritis of the hip or knee and who were in need of and waiting for joint replacement.

The most common adverse reactions ( ≥ 5%) in a double-blind, randomized, placebo-controlled clinical trial in patients with severe pain were nausea, vomiting, somnolence, dizziness, insomnia, constipation, hyperhidrosis, fatigue, feeling cold, and anorexia. Other common adverse reactions ( ≥ 5%) reported in clinical trials in patients with chronic malignant or nonmalignant pain were headache and diarrhea. Adverse reactions reported for ≥ 1% of DURAGESIC-treated patients and with an incidence greater than placebo-treated patients are shown in Table 3.

The most common adverse reactions that were associated with discontinuation in patients with pain (causing discontinuation in ≥ 1% of patients) were depression, dizziness, somnolence, headache, nausea, vomiting, constipation, hyperhidrosis, and fatigue.

Table 3: Adverse Reactions Reported by ≥ 1% of DURAGESIC-treated Patients and With an Incidence Greater Than Placebo-treated Patients in 1 Double-Blind, Placebo-Controlled Clinical Trial of DURAGESIC

System/Organ Class
Adverse Reaction
DURAGESIC %
(N=216)
Placebo %
(N=200)
Cardiac disorders
Palpitations 4 1
Ear and labyrinth disorders
Vertigo 2 1
Gastrointestinal disorders
Nausea 41 17
Vomiting 26 3
Constipation 9 1
Abdominal pain upper 3 2
Dry mouth 2 0
General disorders and administration site conditions
Fatigue 6 3
Feeling cold 6 2
Malaise 4 1
Asthenia 2 0
Edema peripheral 1 1
Metabolism and nutrition disorders
Anorexia 5 0
Musculoskeletal and connective tissue disorders
Muscle spasms 4 2
Nervous system disorders
Somnolence 19 3
Dizziness 10 4
Psychiatric disorders
Insomnia 10 7
Depression 1 0
Skin and subcutaneous tissue disorders
Hyperhidrosis 6 1
Pruritus 3 2
Rash 2 1

Adverse reactions not reported in Table 1 that were reported by ≥ 1% of DURAGESIC-treated adult and pediatric patients (N=1854) in 11 controlled and uncontrolled clinical trials of DURAGESIC used for the treatment of chronic malignant or nonmalignant pain are shown in Table 4.

Table 4: Adverse Reactions Reported by ≥ 1% of DURAGESIC-treated Patients in 11 Clinical Trials of DURAGESIC

System/Organ Class
Adverse Reaction
DURAGESIC %
(N=1854)
Gastrointestinal disorders
Diarrhea 10
Abdominal pain 3
Immune system disorders
Hypersensitivity 1
Nervous system disorders
Headache 12
Tremor 3
Paresthesia 2
Psychiatric disorders
Anxiety 3
Confusional state 2
Hallucination 1
Renal and urinary disorders
Urinary retention 1
Skin and subcutaneous tissue disorders
Erythema 1

The following adverse reactions occurred in adult and pediatric patients with an overall frequency of < 1% and are listed in descending frequency within each System/Organ Class:

Cardiac disorders: cyanosis

Eye disorders: miosis

Gastrointestinal disorders: subileus

General disorders and administration site conditions: application site reaction, influenza-like illness, application site hypersensitivity, drug withdrawal syndrome, application site dermatitis

Musculoskeletal and connective tissue disorders: muscle twitching

Nervous system disorders: hypoesthesia

Psychiatric disorders: disorientation, euphoric mood

Reproductive system and breast disorders: erectile dysfunction, sexual dysfunction

Respiratory, thoracic and mediastinal disorders: respiratory depression

Skin and subcutaneous tissue disorders: eczema, dermatitis allergic, dermatitis contact

Pediatrics

The safety of DURAGESIC was evaluated in three open-label trials in 289 pediatric patients with chronic pain, 2 years of age through 18 years of age. Adverse reactions reported by ≥ 1% of DURAGESIC-treated pediatric patients are shown in Table 5.

Table 5: Adverse Reactions Reported by ≥ 1% of DURAGESIC-treated Pediatric Patients in 3 Clinical Trials of DURAGESIC

System/Organ Class
Adverse Reaction
DURAGESIC %
(N=289)
Gastrointestinal disorders
Vomiting 34
Nausea 24
Constipation 13
Diarrhea 13
Abdominal pain 9
Abdominal pain upper 4
Dry mouth 2
General disorders and administration site conditions
Edema peripheral 5
Fatigue 2
Application site reaction 1
Asthenia 1
Immune system disorders
Hypersensitivity 3
Metabolism and nutrition disorders
Anorexia 4
Musculoskeletal and connective tissue disorders
Muscle spasms 2
Nervous system disorders
Headache 16
Somnolence 5
Dizziness 2
Tremor 2
Hypoesthesia 1
Psychiatric disorders
Insomnia 6
Anxiety 4
Depression 2
Hallucination 2
Renal and urinary disorders
Urinary retention 3
Respiratory, thoracic and mediastinal disorders
Respiratory depression 1
Skin and subcutaneous tissue disorders
Pruritus 13
Rash 6
Hyperhidrosis 3
Erythema 3

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of DURAGESIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Cardiac Disorders: tachycardia, bradycardia

Eye Disorders: vision blurred

Gastrointestinal Disorders: ileus, dyspepsia

General Disorders and Administration Site Conditions: pyrexia

Immune System Disorders: anaphylactic shock, anaphylactic reaction, anaphylactoid reaction

Investigations: weight decreased

Nervous System Disorders: convulsions (including clonic convulsions and grand mal convulsion), amnesia, depressed level of consciousness, loss of consciousness

Psychiatric Disorders: agitation

Respiratory, Thoracic, and Mediastinal Disorders: respiratory distress, apnea, bradypnea, hypoventilation, dyspnea

Vascular Disorders: hypotension, hypertension

Read the entire FDA prescribing information for Duragesic (Fentanyl Transdermal)

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