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

  • Abuse Potential [see WARNINGS AND PRECAUTIONS]
  • Respiratory Depression [see WARNINGS AND PRECAUTIONS]
  • Accidental Exposure [see WARNINGS AND PRECAUTIONS]
  • Elderly, Cachetic, and Debilitated Patients [see WARNINGS AND PRECAUTIONS]
  • Chronic Pulmonary Disease [see WARNINGS AND PRECAUTIONS]
  • Head Injuries and Increased Intracranial Pressure [see WARNINGS AND PRECAUTIONS]
  • Interactions with Other CNS Depressants, Alcohol, and Drugs of Abuse [see WARNINGS AND PRECAUTIONS]
  • Interactions with CYP3A4 Inhibitors [see WARNINGS AND PRECAUTIONS]
  • Application of External Heat [see WARNINGS AND PRECAUTIONS]
  • Patients with Fever [see WARNINGS AND PRECAUTIONS]
  • Cardiac Disease [see WARNINGS AND PRECAUTIONS]
  • Hepatic Impairment [see WARNINGS AND PRECAUTIONS]
  • Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Use in Pancreatic/Biliary Tract Disease [see WARNINGS AND PRECAUTIONS]
  • Avoidance of Withdrawal [see WARNINGS AND PRECAUTIONS]
  • Driving and Operating Machinery [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 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