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Fentanyl (Fentanyl Citrate) - Side Effects and Adverse Reactions



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

Pre-Marketing Clinical Trial Experience

Although fentanyl transdermal system use in post-operative or acute pain and in patients who are not opioid-tolerant is CONTRAINDICATED, the safety of fentanyl transdermal system 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 fentanyl transdermal system use varied in cancer patients; 56% of patients used fentanyl transdermal system for over 30 days, 28% continued treatment for more than 4 months, and 10% used fentanyl transdermal system for more than 1 year.

Hypoventilation was the most serious adverse reaction observed in 13 (4%) postoperative 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 fentanyl transdermal system was not always determined. The frequencies presented here reflect the actual frequency of each adverse effect in patients who received fentanyl transdermal system. 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 fentanyl transdermal system has been evaluated in 291 patients with chronic pain 2 to 18 years of age. The duration of fentanyl transdermal system use varied; 20% of pediatric patients were treated for ≤ 15 days; 46% for 16 to 30 days; 16% for 31 to 60 days; and 17% for at least 61 days. Twenty-five patients were treated with fentanyl transdermal system for at least 4 months and 9 patients for more than 9 months.

There was no apparent pediatric-specific risk associated with fentanyl transdermal system 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% to 10% of fentanyl transdermal system patients
**Reactions occurring in 10% or more of fentanyl transdermal system 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 fentanyl transdermal system 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


Below is a sample of reports where side effects / adverse reactions may be related to Fentanyl. The information is not vetted and should not be considered as verified clinical evidence.

Possible Fentanyl side effects / adverse reactions in 61 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-03

Patient: 61 year old female weighing 78.0 kg (171.6 pounds)

Reactions: Hypoventilation, Tachycardia, Anaphylactic Reaction, Ventricular Fibrillation

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Amoxicillin and Clavulanate Potassium
    Dosage: 1.2 g, unk
    Indication: Prophylaxis
    Start date: 2011-09-15

Rocuronium Bromide
    Dosage: unk
    Indication: Neuromuscular Blockade
    Start date: 2011-09-15

    Dosage: unk
    Indication: Induction of Anaesthesia
    Start date: 2011-09-15

    Indication: Induction of Anaesthesia

Other drugs received by patient: Acetaminophen; Ibuprofen; Morphine Sulfate

Possible Fentanyl side effects / adverse reactions in 49 year old female

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 49 year old female weighing 49.4 kg (108.8 pounds)

Reactions: Product Quality Issue, Pain, Abasia, Intentional Drug Misuse, Treatment Noncompliance, Malaise, Hot Flush, Insomnia, Withdrawal Syndrome

Suspect drug(s):
    Dosage: 100 ug/hr + 25 ug/hr =125 ug/hr
    Indication: Fibromyalgia
    End date: 2011-08-01

    Indication: Fibromyalgia
    Start date: 2011-08-01
    End date: 2011-08-01

Other drugs received by patient: Premarin; Pain Medication (Unknown)

Possible Fentanyl side effects / adverse reactions in 45 year old female

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 45 year old female weighing 73.5 kg (161.7 pounds)

Reactions: Weight Decreased, Dysphoria, Wrong Technique in Drug Usage Process, Pain, Product Adhesion Issue, Hyperhidrosis, Gastritis, Abdominal Discomfort, Malaise, Neck Pain, Ileus, Gallbladder Disorder, Stress Ulcer, Blood Glucose Increased, Back Pain, Vomiting, Dyspnoea, Chest Discomfort, Nausea, Urinary Tract Infection, Skin Disorder, Hepatic Enzyme Increased, Diarrhoea, NO Therapeutic Response, Application Site Ulcer, Asthenia

Suspect drug(s):
    Indication: Pain

    Indication: Pain

    Indication: Pain

    Dosage: 50 mg;tid
    Start date: 2010-06-22
    End date: 2010-06-24

Other drugs received by patient: Prilosec; Lyrica; Milk OF Magnesia TAB; Dicyclomine; Glucophage; Promethazine; Humulin R; Xanax; Oxycontin; Ciprofloxacin; Ortho TRI-Cyclen; Paxil; Humulin N; Lisinopril; Enablex; Valtrex; Januvia; Diflucan

See index of all Fentanyl side effect reports >>

Drug label data at the top of this Page last updated: 2014-07-10

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