Fentanyl Citrate
Injection · Intravenous, Intramuscular
• Fentanyl Citrate Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. ( 5.1 )
• Serious, life-threatening, or fatal respiratory depression may occur with use Fentanyl Citrate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Fentanyl Citrate Injection are essential. ( 5.2 )
• Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in…
Current shortage
Fentanyl Citrate, Injection, 100 mcg/2 mL (50 ug/1 mL) (NDC 0409-9094-22) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6030-01) – Available (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released.
Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-50) – Available (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Check wholesalers for inventory
Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6029-25) – Available (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released.
Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 63323-808-11) – Available (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Check wholesalers for inventory
Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-02) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Next release September 2026. Check wholesalers for inventory.
Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6027-25) – Available (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released.
Fentanyl Citrate, Injection, 2500 mcg/50 mL (50 ug/1 mL) (NDC 0409-9094-61) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6247-25) – Available (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released.
Fentanyl Citrate, Injection, 250 mcg/5 mL (50 ug/1 mL) (NDC 0409-9094-25) – Available (Hospira, Inc., a Pfizer Company, updated Sep 9, 2026)
Uses
Fentanyl Citrate Injection is indicated for:
• analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.
• use as an opioid analgesic supplement in general or regional anesthesia.
• administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
• use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. Fentanyl Citrate Injection is an opioid agonist indicated for ( 1 ):
• analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.
• use as an opioid analgesic supplement in general or regional anesthesia.
• administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
• use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.
Dosage and administration
• Fentanyl Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids. ( 2.1 )
• Ensure that an opioid overdose reversal agent, resuscitative and intubation equipment, and oxygen are readily available. ( 2.1 )
• Individualize dosing based on the factors such as age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved. ( 2.1 )
• Initiate treatment in adults with 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL). ( 2.2 )
• Initiate treatment in children 2 to 12 years of age with a reduced dose as low as 2 to 3 mcg/kg. ( 2.2 ) 2.1 Important Dosage and Administration Instructions Fentanyl Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids.
• Ensure that an opioid overdose reversal agent (e.g., naloxone, nalmefene) , resuscitative and intubation equipment, and oxygen are readily available.
• Individualize dosage based on factors such as age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved.
• Monitor vital signs routinely. As with other potent opioids, the respiratory depressant effect of fentanyl may persist longer than the measured analgesic effect. The total dose of all opioid agonists administered should be considered by the practitioner before ordering opioid analgesics during recovery from anesthesia. If Fentanyl Citrate Injection is administered with a CNS depressant, become familiar with the properties of each drug, particularly each product's duration of action. In addition, when such a combination is used, fluids and other countermeasures to manage hypotension should be available [see Warnings and Precautions (5.3) ] . Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 2.2 Dosage 50 mcg = 0.05 mg = 1 mL Premedication in Adults 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL) may be administered intramuscularly 30 to 60 minutes prior to surgery. Adjunct to General Anesthesia See Dosage Range Charts below. Table 1: Dosage Range Chart TOTAL DOSAGE (expressed as fentanyl base) Low Dose – Moderate Dose – High Dose – 2 mcg/kg (0.002 mg/kg) (0.04 mL/kg). For use in minor, but painful, surgical procedures. May also provide some pain relief in the immediate postoperative period. 2–20 mcg/kg (0.002–0.02 mg/kg) (0.04–0.4 mL/kg). For use in major surgical procedures, in addition to adequate analgesia, may abolish some of the stress response. Expect respiratory depression requiring artificial ventilation during anesthesia and careful observation of ventilation postoperatively is essential. 20–50 mcg/kg (0.02–0.05 mg/kg) (0.4–1 mL/kg). For open heart surgery and certain more complicated neurosurgical and orthopedic procedures where surgery is more prolonged, and the stress response to surgery would be detrimental to the wellbeing of the patient. In conjunction with nitrous oxide/oxygen has been shown to attenuate the stress response as defined by increased levels of circulating growth hormone, catecholamine, ADH and prolactin. Expect the need for postoperative ventilation and observation are essential due to extended postoperative respiratory depression. MAINTENANCE DOSE (expressed as fentanyl base) Low Dose – Moderate Dose – High Dose – 2 mcg/kg (0.002 mg/kg) (0.04 mL/kg). Additional dosages are infrequently needed in these minor procedures. 2–20 mcg/kg (0.002–0.02 mg/kg) (0.04–0.4 mL/kg). 25 to 100 mcg (0.025 to 0.1 mg) (0.5 to 2 mL) Administer intravenously or intramuscularly as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. 20–50 mcg/kg (0.02–0.05 mg/kg) (0.4–1 mL/kg). Maintenance dosage [ranging from 25 mcg (0.025 mg) (0.5 mL) to one half the initial loading dose] as needed based on vital signs changes indicative of stress and lightening of analgesia. Individualize dosage especially if the anticipated remaining operative time is short. Adjunct to Regional Anesthesia 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL) may be administered intramuscularly or slowly intravenously, over one to two minutes, when additional analgesia is required. Postoperatively (recovery room) 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL) may be administered intramuscularly for the control of pain, tachypnea and emergence delirium. The dose may be repeated in one to two hours as needed. For Induction and Maintenance in Children 2 to 12 Years of Age A reduced dose as low as 2 to 3 mcg/kg is recommended. As a General Anesthetic As a technique to attenuate the responses to surgical stress without the use of additional anesthetic agents, doses of 50 to 100 mcg/kg (0.05 to 0.1 mg/kg) (1 to 2 mL/kg) may be administered with oxygen and a muscle relaxant. In certain cases, doses up to 150 mcg/kg (0.15 mg/kg) (3 mL/kg) may be necessary to produce this anesthetic effect. It has been used for open heart surgery and certain other major surgical procedures in patients for whom protection of the myocardium from excess oxygen demand is particularly indicated, and for certain complicated neurological and orthopedic procedures.
Dosage forms and strengths
• Injection: 50 mcg (0.05 mg)/mL in single-dose Fliptop vial.
• Injection: 50 mcg (0.05 mg)/mL in single-dose ampule.
• Injection: 50 mcg (0.05 mg)/mL in single-dose Fliptop vial. ( 3 )
• Injection: 50 mcg (0.05 mg)/mL in single-dose ampule. ( 3 )
Contraindications
Fentanyl Citrate Injection is contraindicated in patients with:
• Hypersensitivity to fentanyl (e.g., anaphylaxis) [see Adverse Reactions (6) ].
• Hypersensitivity to fentanyl. ( 4 )
Warnings and precautions
• Risks of Skeletal Muscle Rigidity and Skeletal Muscle Movement : Manage with neuromuscular blocking agent. See full prescribing information for more detail on managing these risks. ( 5.5 )
• Severe Cardiovascular Depression : Monitor during dosage initiation and titration. ( 5.6 )
• Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. ( 5.7 )
• Serotonin Syndrome : Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue Fentanyl Citrate Injection if serotonin syndrome is suspected. ( 5.8 )
• Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 )
• Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness : Monitor for sedation and respiratory depression. ( 5.10 ) 5.1 Addiction, Abuse, and Misuse Fentanyl Citrate Injection contains fentanyl, a Schedule CII controlled substance. As an opioid, Fentanyl Citrate Injection exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9) ]. Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when handling Fentanyl Citrate Injection. Strategies to reduce these risks include proper product storage and control practices for a C-II drug. Contact local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product. 5.2 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Adequate facilities should be available for postoperative monitoring and ventilation of patients administered anesthetic doses of Fentanyl Citrate Injection. It is essential that these facilities be fully equipped to handle all degrees of respiratory depression. Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone, nalmefene) , depending on the patient's clinical status [see Overdosage (10) ] . Carbon dioxide (CO 2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. To reduce the risk of respiratory depression, proper dosing and titration of Fentanyl Citrate Injection are essential [see Dosage and Administration (2) ] . As with other potent opioids, the respiratory depressant effect of fentanyl may persist longer than the measured analgesic effect. The total dose of all opioid agonists administered should be considered by the practitioner before ordering opioid analgesics during recovery from anesthesia. Certain forms of conduction anesthesia, such as spinal anesthesia and some peridural anesthetics, can alter respiration by blocking intercostal nerves. Through other mechanisms [see Clinical Pharmacology (12.2) ] Fentanyl Citrate Injection can also alter respiration. Therefore, when Fentanyl Citrate Injection is used to supplement these forms of anesthesia, the anesthetist should be familiar with the physiological alterations involved and be prepared to manage them in the patients selected for these forms of anesthesia. Patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of Fentanyl Citrate Injection. Elderly, cachectic, or debilitated patients may have altered pharmacokinetics or altered clearance compared to younger, healthier patients resulting in greater risk for respiratory depression. Monitor such patients closely including vital signs, particularly when initiating and titrating Fentanyl Citrate Injection and when Fentanyl Citrate Injection is given concomitantly with other drugs that depress respiration. To reduce the risk of respiratory depression, proper dosing and titration of Fentanyl Citrate Injection are essential [see Dosage and Administration (2) ] . Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see Dosage and Administration (2.1) ] . 5.3 Risks from Concomitant Use with Benzodiazepines or Other Central Nervous System Depressants When benzodiazepines or other CNS depressants are used with Fentanyl Citrate Injection, pulmonary arterial pressure may be decreased. This fact should be considered by those who conduct diagnostic and surgical procedures where interpretation of pulmonary arterial pressure measurements might determine final management of the patient. When high dose or anesthetic dosages of Fentanyl Citrate Injection are employed, even relatively small dosages of diazepam may cause cardiovascular depression. When Fentanyl Citrate Injection is used with CNS depressants, hypotension can occur. If it occurs, consider the possibility of hypovolemia and manage with appropriate parenteral fluid therapy. When operative conditions permit, consider repositioning the patient to improve venous return to the heart. Exercise care in moving and repositioning of patients because of the possibility of orthostatic hypotension.
Side effects
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). 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 [see Warnings and Precautions (5.11) ] . Most common serious adverse reactions were respiratory depression, apnea, rigidity, and bradycardia. ( 6 ) 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 .
Drug interactions
Table 2 includes clinically significant drug interactions with Fentanyl Citrate Injection. Table 2: Clinically Significant Drug Interactions with Fentanyl Citrate Injection Inhibitors of CYP3A4 Clinical Impact: The concomitant use of Fentanyl Citrate Injection and CYP3A4 inhibitors can increase the plasma concentration of fentanyl, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of Fentanyl Citrate Injection is achieved [see Warnings and Precautions (5.4) ] . After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the fentanyl plasma concentration will decrease [see Clinical Pharmacology (12.3) ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to fentanyl. Intervention: If concomitant use is necessary, consider dosage reduction of Fentanyl Citrate Injection until stable drug effects are achieved [see Dosage and Administration (2) ] . Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the Fentanyl Citrate Injection dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice. CYP3A4 Inducers Clinical Impact: The concomitant use of Fentanyl Citrate Injection and CYP3A4 inducers can decrease the plasma concentration of fentanyl [see Clinical Pharmacology (12.3) ] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to fentanyl [see Warnings and Precautions (5.4) ] . After stopping a CYP3A4 inducer, as the effects of the inducer decline, the fentanyl plasma concentration will increase [see Clinical Pharmacology (12.3) ] , which could increase or prolong both the therapeutic effects and adverse reactions and may cause serious respiratory depression. Intervention: If concomitant use is necessary, consider increasing the Fentanyl Citrate Injection dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Fentanyl Citrate Injection dosage reduction and monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: The concomitant use of Fentanyl Citrate Injection with CNS depressants may result in decreased pulmonary artery pressure and may cause hypotension. Even small dosages of diazepam may cause cardiovascular depression when added to high dose or anesthetic dosages of Fentanyl Citrate Injection. As postoperative analgesia, concomitant use of Fentanyl Citrate Injection can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Intervention: As postoperative analgesia, start with a lower dose of Fentanyl Citrate Injection and monitor patients for signs of respiratory depression, sedation, and hypotension. Fluids or other measures to counter hypotension should be available. [see Warnings and Precautions (5.3) ] . Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome [see Warnings and Precautions (5.8) ]. Intervention: If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Fentanyl Citrate Injection if serotonin syndrome is suspected. Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Monoamine Oxidase Inhibitors Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome [see Warnings and Precautions (5.8) ] or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.2) ] Intervention: The use of Fentanyl Citrate Injection is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Examples: Phenelzine, tranylcypromine, linezolid Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics Clinical Impact: May reduce the analgesic effect of Fentanyl Citrate Injection and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: Butorphanol, nalbuphine, pentazocine, buprenorphine. Muscle Relaxants Clinical Impact: Fentanyl may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Fentanyl Citrate Injection and/or the muscle relaxant as necessary. Examples: Cyclobenzaprine, metaxalone. Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Intervention: Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. Anticholinergic Drugs Clinical Impact: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
Use in specific populations
• Pregnancy : May cause fetal harm. ( 8.1 )
• Lactation : Infants exposed to Fentanyl Citrate Injection through breast milk should be monitored for excess sedation and respiratory depression. ( 8.2 )
• Geriatric Patients : Titrate slowly and monitor for CNS and respiratory depression. ( 8.5 ) 8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause Neonatal Opioid Withdrawal Syndrome. Available data with Fentanyl Citrate Injection in pregnant women are insufficient to inform a drug‑associated risk for major birth defects and miscarriage or adverse maternal outcomes. There are adverse outcomes reported with fetal exposure to opioid analgesics [see Clinical Considerations ] . In animal reproduction studies, fentanyl administration to pregnant rats during organogenesis was embryocidal at doses within the range of the human recommended dosing. No evidence of malformations was noted in animal studies completed to date [see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Fentanyl Citrate Injection is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Fentanyl Citrate Injection, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data Fentanyl has been shown to embryocidal in pregnant rats at doses of 30 mcg/kg intravenously (0.05 times the human dose of 100 mcg/kg on a mg/m 2 basis) and 160 mcg/kg subcutaneously (0.26 times the human dose of 100 mcg/kg on a mg/m 2 basis). There was no evidence of teratogenicity reported. No evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered fentanyl continuously via subcutaneously implanted osmotic minipumps at doses of 10, 100, or 500 mcg/kg/day starting 2-weeks prior to breeding and throughout pregnancy. The high dose was approximately 0.81 times the human dose of 100 mcg/kg on a mg/m 2 basis. 8.2 Lactation Risk Summary Fentanyl is present in breast milk. However, there is insufficient information to determine the effects of fentanyl on the breastfed infant and the effects of fentanyl on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Fentanyl Citrate Injection and any potential adverse effects on the breastfed infant from Fentanyl Citrate Injection or from the underlying maternal condition. Clinical Considerations Monitor infants exposed to Fentanyl Citrate Injection through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. 8.3 Females and Males of Reproductive Potential Infertility Use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6) , Clinical Pharmacology (12.2) , Nonclinical Toxicology (13.1) ]. 8.4 Pediatric Use The safety and efficacy of Fentanyl Citrate Injection in children under two years of age has not been established. Rare cases of unexplained clinically significant methemoglobinemia have been reported in premature neonates undergoing emergency anesthesia and surgery which included the combined use of fentanyl, pancuronium and atropine. A direct cause and effect relationship between the combined use of these drugs and the reported cases of methemoglobinemia has not been established. 8.5 Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity to fentanyl. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
Pregnancy
8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause Neonatal Opioid Withdrawal Syndrome. Available data with Fentanyl Citrate Injection in pregnant women are insufficient to inform a drug‑associated risk for major birth defects and miscarriage or adverse maternal outcomes. There are adverse outcomes reported with fetal exposure to opioid analgesics [see Clinical Considerations ] . In animal reproduction studies, fentanyl administration to pregnant rats during organogenesis was embryocidal at doses within the range of the human recommended dosing. No evidence of malformations was noted in animal studies completed to date [see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Fentanyl Citrate Injection is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Fentanyl Citrate Injection, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data Fentanyl has been shown to embryocidal in pregnant rats at doses of 30 mcg/kg intravenously (0.05 times the human dose of 100 mcg/kg on a mg/m 2 basis) and 160 mcg/kg subcutaneously (0.26 times the human dose of 100 mcg/kg on a mg/m 2 basis). There was no evidence of teratogenicity reported. No evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered fentanyl continuously via subcutaneously implanted osmotic minipumps at doses of 10, 100, or 500 mcg/kg/day starting 2-weeks prior to breeding and throughout pregnancy. The high dose was approximately 0.81 times the human dose of 100 mcg/kg on a mg/m 2 basis.
Pediatric use
8.4 Pediatric Use The safety and efficacy of Fentanyl Citrate Injection in children under two years of age has not been established. Rare cases of unexplained clinically significant methemoglobinemia have been reported in premature neonates undergoing emergency anesthesia and surgery which included the combined use of fentanyl, pancuronium and atropine. A direct cause and effect relationship between the combined use of these drugs and the reported cases of methemoglobinemia has not been established.
Geriatric use
8.5 Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity to fentanyl. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of Fentanyl Citrate Injection slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.2) ] . Fentanyl is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Overdosage
Clinical Presentation Acute overdose with fentanyl can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2) ] . Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication. Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures. For clinically significant respiratory or circulatory depression secondary to fentanyl overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. Because the duration of opioid reversal is expected to be less than the duration of action of fentanyl in Fentanyl Citrate Injection, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent as directed by the product's prescribing information. In an individual physically-dependent on opioids, administration of the recommended usual dosage of the opioid overdose reversal agent will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the reversal agent administered. If a decision is made to treat serious respiratory depression in the physically-dependent patient, administration of the reversal agent should be initiated with care and by titration with smaller than usual doses of the reversal agent.
Description
Fentanyl Citrate Injection is an opioid agonist. Fentanyl Citrate Injection, is a sterile, nonpyrogenic solution of fentanyl citrate in water for injection, available as 50 mcg (0.05 mg) per mL which is administered only by the intravenous or intramuscular routes of injection. The chemical name is N-(1-phenethyl-4-piperidyl) propionanilide citrate (1:1). The molecular weight is 528.60. Its molecular formula is C 22 H 28 N 2 O∙C 6 H 8 O 7 , and it has the following chemical structure. Fentanyl citrate, a white powder which is sparingly soluble in water. Each milliliter contains fentanyl (as the citrate) 50 mcg (0.05 mg). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 4.7 (4.0 to 7.5). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded in an appropriate manner. Chemical Structure
Mechanism of action
12.1 Mechanism of Action Fentanyl is an opioid agonist whose principal actions of therapeutic value are analgesic and sedation.
How supplied
Fentanyl Citrate Injection, USP equivalent to 50 mcg (0.05 mg) fentanyl per mL, is supplied in single-dose ampules and single-dose vials for intramuscular and intravenous administration, and available as follows: Unit of Sale Concentration NDC 0409-9094-22 Tray containing 25, 2 mL Single-dose Fliptop Vials 100 mcg Fentanyl/2 mL (50 mcg/mL) NDC 0409-9094-25 Tray containing 25, 5 mL Single-dose Fliptop Vials 250 mcg Fentanyl/5 mL (50 mcg/mL) NDC 0409-9093-36 Carton containing 5, 10 mL Single-dose Ampules 500 mcg Fentanyl/10 mL (50 mcg/mL) NDC 0409-9094-28 Tray containing 25, 10 mL Single-dose Fliptop Vials 500 mcg Fentanyl/10 mL (50 mcg/mL) NDC 0409-9093-38 Carton containing 5, 20 mL Single-dose Ampules 1000 mcg Fentanyl/20 mL (50 mcg/mL) NDC 0409-9094-31 Tray containing 25, 20 mL Single-dose Fliptop Vials 1000 mcg Fentanyl/20 mL (50 mcg/mL) NDC 0409-9094-61 Tray containing 25, 50 mL Single-dose Fliptop Vials 2500 mcg Fentanyl/50 mL (50 mcg/mL) NDC 0409-9094-55 Carton containing 1, 50 mL Single-dose Fliptop Vial 2500 mcg Fentanyl/50 mL (50 mcg/mL) Protect from light. Retain in carton until time of use. Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature.]
Storage
Protect from light. Retain in carton until time of use. Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature.]
Patient information
Addiction, Abuse, and Misuse Inform patients that the use of Fentanyl Citrate Injection, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1) ] . Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Fentanyl Citrate Injection or when the dosage is increased, and that it can occur even at recommended dosages [see Warnings and Precautions (5.2) ]. Hyperalgesia and Allodynia Advise patients to inform their healthcare provider if they experience symptoms of hyperalgesia, including worsening pain, increased sensitivity to pain, or new pain [see Warnings and Precautions (5.7) , Adverse Reactions (6) ]. Serotonin Syndrome Inform patients that opioids could cause a rare but potentially life-threatening condition called serotonin syndrome resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop after discharge from the hospital. Instruct patients to inform their healthcare provider if they are taking, or plan to take serotonergic medications [see Warnings and Precautions (5.8) , Drug Interactions (7) ] . Constipation Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Clinical Pharmacology (12.2) ] .
Label text from the FDA structured product label by Hospira, Inc. (revised Aug 24, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Fentanyl Citrate in 18 products
Fentanyl Citrate NDC products (18)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 63323-806 | Fentanyl Citrate .05 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA · DEA CII |
| 63323-808 | Fentanyl Citrate 50 ug/mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA · DEA CII |
| 63323-810 | Fentanyl Citrate 100 ug/2mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA · DEA CII |
| 72572-172 | Fentanyl Citrate 50 ug/mL Injection | Civica, Inc. | NDA · DEA CII |
| 72572-170 | Fentanyl Citrate 50 ug/mL Injection | Civica, Inc. | NDA · DEA CII |
| 72572-171 | Fentanyl Citrate 50 ug/mL Injection | Civica, Inc. | NDA · DEA CII |
| 0641-6027 | Fentanyl Citrate 50 ug/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0641-6028 | Fentanyl Citrate 50 ug/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0641-6029 | Fentanyl Citrate 50 ug/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0641-6030 | Fentanyl Citrate 50 ug/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0641-6247 | Fentanyl Citrate 50 ug/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0641-6248 | Fentanyl Citrate 50 ug/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0641-6249 | Fentanyl Citrate 50 ug/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0641-6289 | Fentanyl Citrate 50 ug/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0641-6290 | Fentanyl Citrate 50 ug/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0409-9094 | Fentanyl Citrate 50 ug/mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 0409-9093 | Fentanyl Citrate 50 ug/mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 81565-205 | Fentanyl Citrate 50 ug/mL Injection | Phlow Corp. | NDA · DEA CII |
Fentanyl Citrate recalls
- D-1446-2020 Aug 12, 2020 · Class II · Terminated
Lack of Assurance of Sterility; potential loose metal overseal crimp defects. - D-1139-2015 Jun 24, 2015 · Class III · Terminated
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548). - D-0420-2015 Apr 1, 2015 · Class III · Terminated
Failed Impurities/Degradation Specifications; 12 month stability testing. - D-0294-2015 Dec 17, 2014 · Class II · Terminated
Lack of Assurance of Sterility; improperly crimped fliptop vials - D-1433-201 Jul 23, 2014 · Class II · Terminated
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Frequently asked questions
What is Fentanyl Citrate used for?
Fentanyl Citrate Injection is indicated for: • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. • use as an opioid analgesic supplement in general or regional anesthesia. • administration with a neuroleptic as an anesthetic premedication, for the induction of…
What are the side effects of Fentanyl Citrate?
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… See the full label for the complete list.
Who makes Fentanyl Citrate?
Fentanyl Citrate is listed by 5 labelers in the FDA NDC directory, including Fresenius Kabi USA, LLC, Civica, Inc., Hikma Pharmaceuticals USA Inc., Hospira, Inc..
Has Fentanyl Citrate been recalled?
The FDA enforcement database lists 5 recalls for Fentanyl Citrate, most recently D-1446-2020 (class ii): Lack of Assurance of Sterility; potential loose metal overseal crimp defects.