Actiq Side Effects

Generic Name: fentanyl

Please note - some side effects for Actiq may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Actiq - for the Consumer

Actiq Lozenge

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Actiq Lozenge:

Accidental injury; anxiety; confusion; constipation; difficulty walking; dizziness; drowsiness; dry mouth; headache; indigestion; itching; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive dizziness; excessive drowsiness; fainting; fatigue; hallucinations; muscle rigidity; seizures; shock (changes in skin color); slow heartbeat; slowed breathing; trouble breathing; weakness.

Actiq Side Effects - for the Professional

Actiq

Most common adverse reactions during titration phase (frequency ≥5%): nausea, dizziness, somnolence, vomiting, asthenia, and headache. (6.1)

Most common adverse reactions during treatment (frequency ≥5%): dyspnea, constipation, anxiety, confusion, depression, rash, and insomnia. (6.1)

Dental decay has been reported. (6.2)

Side Effects by Body System

Nervous system

Nervous system side effects have included mental and respiratory depression (particularly in the elderly), stupor, delirium, somnolence, and dysphoria. Muscle rigidity (involving the respiratory musculature including the glottis) may also occur and further aggravate the respiratory depression associated with fentanyl therapy. Myoclonus has been reported with the use of transdermal therapy. A case of severe hemiplegic migraine attack precipitated by fentayl sedation has also been reported.

Cases of seizures have occasionally been reported, but some investigators have suggested that the seizure-like events reported may have been episodes of fentanyl induced-rigidity.

Other

Fentanyl shares the potential for abuse associated with other narcotic analgesics. Cases of inhalation of the contents of fentanyl patches and oral ingestion of intravenous preparations have been reported.

Other side effects have included withdrawal symptoms (agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, and sweating) after either abrupt cessation or fast tapering of narcotic analgesics.

Cardiovascular

Cardiovascular side effects have included hypotension, bradycardia, and arrhythmias rarely.

One report has suggested that epidural fentanyl may mask the pain of myocardial ischemia in patients treated with fentanyl for other reasons. Another report has suggested that QTc interval prolongation may occur in some patients receiving the related narcotic sufentanil. Another report has implicated fentanyl as a potential cause of pulsus alternans in a patient with aortic stenosis and congestive heart failure.

Nevertheless, fentanyl has been advocated by some as a satisfactory agent for coronary artery surgery.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and constipation have been reported to have occurred commonly. Dental decay of varying severity including dental caries, tooth loss, and gum line erosion have been reported. Choledochoduodenal sphincter spasm has been reported rarely.

Respiratory

Respiratory side effects have included respiratory depression which has been frequently observed with fentanyl therapy and one case of acute noncardiogenic pulmonary edema. Coughing has been reported following fentanyl administration for anesthesia induction.

Genitourinary

Genitourinary side effects including urinary retention have been reported for other narcotic analgesics. A case of priapism has been associated with fentanyl anesthesia.

Dermatologic

Dermatologic side effects have included pruritus which has been reported frequently. Localized rashes (associated with the use of transdermal fentanyl patches) and, less commonly, systemic rashes have also been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported rarely.

Hematologic

The hemolysis observed may have been related to rapid injection of large volumes of hypotonic fentanyl solution. The authors therefore recommend slower injection rates and/or mixture in isotonic fluid.

Hematologic side effects have included one study which suggested that a small amount of hemolysis (of uncertain clinical significance) may occur in patients treated with fentanyl.

Immunologic

Immunologic side effects including a case of recurrent herpes simplex infection have been reported following epidural administration of fentanyl. Intravenous fentanyl has been reported to increase natural killer cell cytotoxicity and circulating CD16+ lymphocyte levels.

Metabolic

Metabolic side effects including a case of syndrome of inappropriate antidiuretic hormone have been reported.

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