Medical Editor: John P. Cunha, DO, FACOEP
What Is Fentanyl Transdermal System?
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. Fentanyl Transdermal System is available in generic form.
What Are Side Effects of Fentanyl Transdermal System?
Common side effects of Fentanyl Transdermal System include:
- nausea
- vomiting
- drowsiness
- dizziness
- vertigo
- insomnia
- constipation
- increased sweating
- fatigue
- feeling cold
- weight loss
- headache
- diarrhea
- palpitations
- ear problems
- abdominal pain
- dry mouth
- feeling unwell (malaise)
- weakness
- swelling of the extremities
- muscle spasms
- depression
- itching, and
- rash
Dosage for Fentanyl Transdermal System
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 Fentanyl Transdermal System?
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.
Fentanyl Transdermal System During Pregnancy or Breastfeeding
Fentanyl Transdermal System is not recommended for use during pregnancy; it may harm a fetus. Fentanyl Transdermal System passes into breast milk and may cause undesirable side effects in a nursing infant. Breastfeeding is not recommended while using Fentanyl Transdermal System. Withdrawal symptoms may occur if you suddenly stop taking Fentanyl Transdermal System.
Additional Information
Our 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.
SLIDESHOW
Back Pain: 16 Back Pain Truths and Myths See SlideshowGet 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 Fentanyl Transdermal System (Fentanyl Transdermal System for Transdermal Administration)
QUESTION
Medically speaking, the term "myalgia" refers to what type of pain? See AnswerSIDE EFFECTS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Accidental Exposure [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Interactions with Central Nervous System Depressants [see WARNINGS AND PRECAUTIONS]
- Hypotensive Effects [see WARNINGS AND PRECAUTIONS]
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 fentanyl transdermal system was evaluated in 216 patients who took at least one dose of fentanyl transdermal system in a multicenter, double-blind, randomized, placebo-controlled clinical trial of fentanyl transdermal system. 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, placebocontrolled 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 fentanyl transdermal system-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
Fentanyl Transdermal System-treated Patients and With an Incidence Greater Than
Placebo-treated Patients in 1 Double-Blind, Placebo-Controlled Clinical Trial
of Fentanyl Transdermal System
| System/Organ Class Adverse Reaction | Fentanyl Transdermal System % (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 3 that were reported by ≥ 1% of fentanyl transdermal system-treated adult and pediatric patients (N=1854) in 11 controlled and uncontrolled clinical trials of fentanyl transdermal system used for the treatment of chronic malignant or nonmalignant pain are shown in Table 4.
Table 4: Adverse Reactions Reported by ≥ 1% of
Fentanyl Transdermal System-treated Patients in 11 Clinical Trials of Fentanyl
Transdermal System
| System/Organ Class Adverse Reaction | Fentanyl Transdermal System % (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 fentanyl transdermal system 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 fentanyl transdermal system-treated pediatric patients are shown in Table 5.
Table 5: Adverse Reactions Reported by ≥ 1% of
Fentanyl Transdermal System-treated Pediatric Patients in 3 Clinical Trials of
Fentanyl Transdermal System
| System/Organ Class Adverse Reaction | Fentanyl Transdermal System % (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 fentanyl transdermal system. 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 Fentanyl Transdermal System (Fentanyl Transdermal System for Transdermal Administration)
© Fentanyl Transdermal System Patient Information is supplied by Cerner Multum, Inc. and Fentanyl Transdermal System Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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