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Duragesic

"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...

Duragesic

Duragesic

Duragesic Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Duragesic (fentanyl) is an opioid analgesic that is used for patients with chronic pain that is persistent, not managed by other opioids or non-steroidal analgesics, and are opioid-tolerant (patients who have been taking opioids daily for at least a week in relatively high concentrations such as 60 mg morphine, 30 mg of oxycodone or 8 mg of oral hydromorphone daily). Duragesic format should not be used in patients that are not opioid-tolerant or in patients that need short-term pain control as the side effect of hypoventilation can be serious enough to cause brain damage or death.

Duragesic is available in transdermal patches (patches impregnated with Duragesic that is absorbed through the skin) of various sizes that deliver about 25 micrograms per hour per every 10.5 cm2 of patch (23 mcg/h/10.5 cm2). Each patch lasts for about 72 hours. The patches are available in 12, 25, 50, 75 and 100 mcg/h sizes. Initial dosages can be equated to morphine and other opioids by tables available in the medical literature (Dose Conversion Tables). Patients should not alter the dosage of Duragesic without discussing changes with the physician that prescribed the drug. Patches should be placed on normal, unshaven skin, usually on the back or side. Do not use any Duragesic patch that has been opened previously or is damaged in any way. Safe use in children below age 2 is not established, and above age two, Duragesic is used only in those children known to be opioid-tolerant. While women who are breastfeeding infants transfer very small amounts of the drug to their infants, the American Academy of Pediatrics consider Duragesic patches on the mother compatible with breastfeeding. Studies done on pregnant women are less clear so the treating physician and patient should realize there may be some fetal and maternal risks if this drug is used. Duragesic should not be used with monoamine oxidase inhibitors (MAOIs), other opioids, sedatives, or any respiratory depressants because its respiratory depression may be enhanced. Duragesic, like other opioids, can and is easily abused (sometimes causing unexpected death in otherwise healthy individuals, including a few physicians); it also can lead to drug dependence. Duragesic use, like other opioids, can be complicated by the situation that opioid users should not have the drug stopped suddenly; they can develop an opioid withdrawal syndrome (patients can develop anxiety, restlessness, nausea, abdominal pain, rapid heartbeats, high blood pressure, increased respiratory rate and other symptoms).

Our Duragesic 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Duragesic in Detail - Patient Information: Side Effects

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

Remove the skin patch and call your doctor at once if you have any of these serious side effects:

  • slow heart rate, weak or shallow breathing, sighing;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe weakness, feeling like you might pass out;
  • cold, clammy skin; or
  • pale skin, easy bruising or bleeding.

Less serious side effects may include:

  • fever;
  • constipation, diarrhea;
  • dry mouth, nausea, vomiting, upset stomach;
  • headache;
  • drowsiness, weakness, tired feeling;
  • feeling anxious or nervous;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • sweating, skin rash; or
  • itching, blistering, redness, or swelling where the patch was worn.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Duragesic Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Mild irritation, itching, or redness at the application site may also occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.

Get medical help right away if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Duragesic (Fentanyl Transdermal)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Duragesic FDA Prescribing Information: Side Effects
(Adverse Reactions)

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: Feeling of body temperature change

Immune System Disorders: Anaphylactic shock, Anaphylactic reaction, Anaphylactoid reaction

Investigations: Weight decreased

Nervous System Disorders: Convulsions (including Clonic convulsions and Grand mal convulsion), Amnesia

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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Duragesic - User Reviews

Duragesic User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Duragesic sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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