DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Duragesic (Fentanyl Citrate Transdermal) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

In post-marketing experience, deaths from hypoventilation due to inappropriate use of DURAGESIC ® (fentanyl transdermal system) have been reported (see BOX WARNING and CONTRAINDICATIONS).

Pre-Marketing Clinical Trial Experience

Although DURAGESIC® use in post-operative or acute pain and in patients who are not opioid-tolerant is CONTRAINDICATED, the safety of DURAGESIC® was originally evaluated in 357 post-operative adult patients for 1 to 3 days and 153 cancer patients for a total of 510 patients. The duration of DURAGESIC® use varied in cancer patients; 56% of patients used DURAGESIC® for over 30 days, 28% continued treatment for more than 4 months, and 10% used DURAGESIC® for more than 1 year.

Hypoventilation was the most serious adverse reaction observed in 13 (4%) post-operative patients and in 3 (2%) of the cancer patients. Hypotension and hypertension were observed in 11 (3%) and 4 (1%) of the opioid-naive patients.

Various adverse events were reported; a causal relationship to DURAGESIC® was not always determined. The frequencies presented here reflect the actual frequency of each adverse effect in patients who received DURAGESIC®. There has been no attempt to correct for a placebo effect, concomitant use of other opioids, or to subtract the frequencies reported by placebo-treated patients in controlled trials.

Adverse reactions reported in 153 cancer patients at a frequency of 1% or greater are presented in Table 1; similar reactions were seen in the 357 post-operative patients.

In the pediatric population, the safety of DURAGESIC® has been evaluated in 291 patients with chronic pain 2-18 years of age. The duration of DURAGESIC® use varied; 20% of pediatric patients were treated for ≤ 15 days; 46% for 16-30 days; 16% for 31-60 days; and 17% for at least 61 days. Twenty-five patients were treated with DURAGESIC® for at least 4 months and 9 patients for more than 9 months.

There was no apparent pediatric-specific risk associated with DURAGESIC® use in children as young as 2 years old when used as directed.

The most common adverse events were fever (35%), vomiting (33%), and nausea (24%).

Adverse events reported in pediatric patients at a rate of ≥1% are presented in Table 1.

TABLE 1: ADVERSE EVENTS (at rate of ≥ 1%) Adult (N=380) and Pediatric (N=291) Clinical Trial Experience

*Reactions occurring in 3% - 10% of DURAGESIC® patients

**Reactions occurring in 10% or more of DURAGESIC® patients

Body System Adults Pediatrics

Body as a Whole Abdominal pain*, headache*, fatigue*, back pain, fever, influenza-like symptoms*, accidental injury, rigors Pain*, headache*, fever, syncope, abdominal pain, allergic reaction, flushing
Cardiovascular Arrhythmia, chest pain Hypertension, tachycardia
Digestive Nausea**, vomiting**, constipation**, dry mouth**, anorexia*, diarrhea*, dyspepsia*, flatulence Nausea**, vomiting**, constipation*, dry mouth, diarrhea
Nervous Somnolence**, insomnia, confusion**, asthenia**, dizziness*, nervousness*, hallucinations*, anxiety*, depression*, euphoria*, tremor, abnormal coordination, speech disorder, abnormal thinking, abnormal gait, abnormal dreams, agitation, paresthesia, amnesia, syncope, paranoid reaction Somnolence*, nervousness*, insomnia*, asthenia*, hallucinations, anxiety, depression, convulsions, dizziness, tremor, speech disorder, agitation, stupor, confusion, paranoid reaction
Respiratory Dyspnea*, hypoventilation*, apnea*, hemoptysis, pharyngitis, hiccups, bronchitis, rhinitis, sinusitis, upper respiratory tract infection* Dyspnea, respiratory depression, rhinitis, coughing
Skin and Appendages Sweating**, pruritus*, rash, application site reaction – erythema, papules, itching, edema Pruritus*, application site reaction*, sweating increased, rash, rash erythematous, skin reaction localized
Urogenital Urinary retention*, Micturition disorder Urinary retention

The following adverse effects have been reported in less than 1% of the 510 adult post-operative and cancer patients studied:

Cardiovascular: bradycardia

Digestive: abdominal distention

Nervous: aphasia, hypertonia, vertigo, stupor, hypotonia, depersonalization, hostility

Respiratory: stertorous breathing, asthma, respiratory disorder

Skin and Appendages, General: exfoliative dermatitis, pustules

Special Senses: amblyopia

Urogenital: bladder pain, oliguria, urinary frequency

Post-Marketing Experience - Adults

The following adverse reactions have been reported in association with the use of DURAGESIC® and not reported in the pre-marketing adverse reactions section above:

Body as a Whole: edema

Cardiovascular: tachycardia

Metabolic and Nutritional: weight loss

Special Senses: blurred vision

Urogenital: decreased libido, anorgasmia, ejaculatory difficulty

Drug label data at the top of this Page last updated: 2008-04-14

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017