Fentanylside effects

The following serious adverse reactions are described, or described in greater detail, in other sections:

Addiction, Abuse, and Misuse

Life-Threatening Respiratory Depression

Interactions with Benzodiazepines or Other CNS Depressants

Severe Cardiovascular Depression

Opioid-Induced Hyperalgesia and Allodynia ‎

Serotonin Syndrome

Gastrointestinal Adverse Reactions

Seizures The following adverse reactions associated with the use of fentanyl were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. As with other opioid agonists, the most common serious adverse reactions reported to occur with fentanyl are respiratory depression, apnea, rigidity, and bradycardia; if these remain untreated, respiratory arrest, circulatory depression or cardiac arrest could occur. Other adverse reactions that have been reported are hypertension, hypotension, dizziness, blurred vision, nausea, emesis, diaphoresis, pruritus, urticarial, laryngospasm, and anaphylaxis. It has been reported that secondary rebound respiratory depression may occasionally occur postoperatively. When a tranquilizer is used with fentanyl, the following adverse reactions can occur: chills and/or shivering, restlessness, and postoperative hallucinatory episodes (sometimes associated with transient periods of mental depression); extrapyramidal symptoms (dystonia, akathisia, and oculogyric crisis) have been observed up to 24 hours postoperatively. When they occur, extrapyramidal symptoms can usually be controlled with anti-parkinson agents. Postoperative drowsiness is also frequently reported following the use of neuroleptics with Fentanyl Citrate Injection. Cases of cardiac dysrhythmias, cardiac arrest, and death have been reported following the use of Fentanyl Citrate Injection with a neuroleptic agent. Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Anaphylaxis: Anaphylaxis has been reported with ingredients contained in Fentanyl Citrate Injection. Androgen deficiency: Cases of androgen deficiency have occurred with use of opioids for an extended period of time. Hyperalgesia and allodynia: Cases of hyperalgesia and allodynia have been ‎reported with opioid therapy of any duration ‎. Hypoglycemia: Cases of hypoglycemia have been reported in patients ‎taking opioids. Most reports were in ‎patients with at least one ‎predisposing risk factor (e.g., diabetes).‎ Opioid-induced esophageal dysfunction (OIED): Cases of OIED have been reported in patients taking opioids and may occur more frequently in patients taking higher doses of opioids, and/or in patients taking opioids longer term. Most common serious adverse reactions were respiratory depression, apnea, rigidity, and bradycardia. To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.