fentanyl citrate injection, USP VIAL , AMPULE Adverse Reactions

()

6 ADVERSE REACTIONS

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

Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)]
Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)]
Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3)]
Severe Cardiovascular Depression [see Warnings and Precautions (5.6)]
Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7)]‎
Serotonin Syndrome [see Warnings and Precautions (5.8)]
Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.11)]
Seizures [see Warnings and Precautions (5.12)]

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 [see Clinical Pharmacology (12.2)].

Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been ‎reported with opioid therapy of any duration [see Warnings and Precautions ‎‎(5.7)]‎.

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).‎

Find fentanyl citrate injection, USP VIAL , AMPULE medical information:

Find fentanyl citrate injection, USP VIAL , AMPULE medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

fentanyl citrate injection, USP VIAL , AMPULE Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Adverse Reactions

6 ADVERSE REACTIONS

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

Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)]
Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)]
Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3)]
Severe Cardiovascular Depression [see Warnings and Precautions (5.6)]
Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7)]‎
Serotonin Syndrome [see Warnings and Precautions (5.8)]
Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.11)]
Seizures [see Warnings and Precautions (5.12)]

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 [see Clinical Pharmacology (12.2)].

Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been ‎reported with opioid therapy of any duration [see Warnings and Precautions ‎‎(5.7)]‎.

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).‎

Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Contact Medical Information. 8AM-9PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.