Prescription medication · Opioid Analgesic
fentanyl
Also sold as Duragesic, Actiq. Fentanyl Citrate Injection is used to manage pain during and after surgery.
Data updated 2026-05-15
- 95,293
- FDA reportsOften reported
- 28
- InteractionsSeveral interactions
- In shortage
- FDA status
What the data shows
fentanyl (Duragesic) is a prescription Opioid Analgesic, more reported than most tracked drugs (95,293 FDA reports), with 28 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
fentanyl (Duragesic) is a prescription Opioid Analgesic. Fentanyl Citrate Injection is used to manage pain during and after surgery.
Fentanyl Citrate Injection is a strong opioid pain medicine. It is used to provide short-term pain relief, often during and after surgery.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
fentanyl is currently listed as in shortage by the FDA. Affected manufacturer: Fresenius Kabi USA, LLC. Status: Unavailable.
View all drug shortages →Drug Pricing (NADAC)
Generic Price
$0.72/unit
Generic Available
Yes (6 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Fentanyl Citrate Injection is used to manage pain during and after surgery.
Common side effects
Nausea, Vomiting, Dizziness
Key warnings
Fentanyl Citrate Injection can cause serious and life-threatening risks: * Addiction, abuse, and misuse can lead to overdose and death.
The sections below are summarized in plain English from fentanyl's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Fentanyl is an opioid that works by binding to receptors in the brain and spinal cord. This binding decreases the feeling of pain. It can also cause sleepiness and slow breathing.
How to Take It
Fentanyl Citrate Injection is given by a healthcare provider through a vein or muscle. The dose will be based on your age, weight, medical condition, and the type of surgery you are having. Your vital signs will be monitored closely while you receive this medicine. Be sure to tell your doctor about all other medicines you are taking.
This is a plain-language summary of fentanyl's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Using fentanyl for a long time during pregnancy can cause withdrawal symptoms in the newborn. Fentanyl is not recommended during labor or delivery because it can cause breathing problems in the baby.
This is a plain-language summary of fentanyl's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
Since Fentanyl Citrate Injection is administered by a healthcare professional, missing a dose is not applicable.
This is a plain-language summary of fentanyl's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature, away from light.
Side Effects (from patient reports)
Based on 95,293 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for fentanyl, by number of reports
- Misuse of drugs
Misuse of drugs
10,453 reports
- Pain
Pain
7,248 reports
- Drug addiction
Drug addiction
6,027 reports
- Harmful effect from drugs
Harmful effect from drugs
5,847 reports
- Taking too much of a drug
Taking too much of a drug
5,722 reports
- Death
Death
5,352 reports
- Feeling sick to your stomach
Feeling sick to your stomach
5,082 reports
- Throwing up 3,691
Throwing up
3,691 reports
- Feeling tired 3,525
Feeling tired
3,525 reports
- Symptoms when stopping a drug 2,968
Symptoms when stopping a drug
2,968 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for fentanyl each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where fentanyl sits
fentanyl has more FDA adverse-event reports than 85% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is fentanyl; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 95,293 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1997–2025.
Total Reports
95,293
Reports Mentioning Death
27,119
28.5% of reports — not proof of cause
Hospitalization Reports
32,091
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG ABUSE | 10,453 |
| 2 | PAIN | 7,250 |
| 3 | DRUG DEPENDENCE | 6,027 |
| 4 | TOXICITY TO VARIOUS AGENTS | 5,846 |
| 5 | OVERDOSE | 5,720 |
| 7 | DEATH | 5,353 |
| 8 | NAUSEA | 5,081 |
| 9 | VOMITING | 3,688 |
| 10 | FATIGUE | 3,525 |
| 12 | DRUG WITHDRAWAL SYNDROME | 2,968 |
| 13 | DYSPNOEA | 2,962 |
| 14 | DIARRHOEA | 2,938 |
| 15 | EMOTIONAL DISTRESS | 2,937 |
| 16 | HYPOTENSION | 2,926 |
| 17 | DRUG INTERACTION | 2,755 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Fentanyl Citrate Injection can cause serious and life-threatening risks: * Addiction, abuse, and misuse can lead to overdose and death. Your doctor will assess your risk before prescribing and monitor you regularly. * Life-threatening respiratory depression (slowed or stopped breathing) can occur, especially when starting the medicine or after a dose increase. Proper dosing is essential. * Taking fentanyl with benzodiazepines (like Valium or Xanax) or other CNS depressants (including alcohol) can cause severe sleepiness, slowed breathing, coma, and death. This combination should be avoided unless there are no other options. * Using fentanyl with certain other medicines (CYP3A4 inhibitors or inducers) can change the amount of fentanyl in your blood, leading to dangerous side effects or withdrawal symptoms. Your doctor will monitor you closely if these medicines are used together.
Known Drug Interactions
Fentanyl Not recommended during and 2 weeks after itraconazole treatment.
Mechanism: Itraconazole prevents your body from breaking down this powerful painkiller. This can cause the drug to reach dangerous levels, which might affect your breathing.
What to do: Do not use this combination during your itraconazole treatment or for two weeks after you finish it.
Product Clinical Comment on Concomitant Use [See Contraindications (4.1)] ; Predominant Effect/Risk [Hypertensive Reaction (HR) [See Warnings and Precautions (5.3)] ; or Serotonin Syndrome (SS) [See Warnings and Precautions (5.7)] ] Altretamine Use with caution If not otherwise specified in this table, consider avoiding concomitant use (see also information on medication-free intervals , use agent at the lowest appropriate dose, monitor for effects of the interaction, advise the patient to report potential effects, and be prepared to discontinue the agent and treat effects of the...
Mechanism: Combining these drugs can cause a dangerous buildup of serotonin or a sudden, severe spike in blood pressure. This happens because both medications change how your body handles certain brain chemicals.
What to do: Avoid using these medications together if possible. If they are necessary, your doctor should use the lowest dose and monitor you closely for any bad reactions.
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).
Mechanism: Both drugs increase a brain chemical called serotonin, and taking them together can cause serotonin levels to become dangerously high.
What to do: Monitor closely for symptoms like confusion, sweating, or shivering, and tell your doctor if you feel unwell.
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).
Mechanism: Both drugs increase the level of a brain chemical called serotonin. Taking them together can cause too much serotonin to build up in your body, which can be dangerous.
What to do: Your doctor should monitor you closely for signs of serotonin syndrome, such as confusion, a fast heartbeat, or muscle stiffness.
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 )] .
Mechanism: This combination can change how your body processes fentanyl, which may lower the amount of medicine in your blood. This can make the pain relief less effective or cause withdrawal symptoms.
What to do: Your doctor may need to adjust your fentanyl dose and watch you closely to ensure the medicine is still working for your pain.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I tell my doctor before receiving Fentanyl Citrate Injection?
Can I drive after receiving Fentanyl Citrate Injection?
What are the signs of an overdose?
Can I drink alcohol while receiving Fentanyl Citrate Injection?
What should I do if I experience side effects?
Is Fentanyl Citrate Injection addictive?
How long will the pain relief last?
Will I experience withdrawal symptoms if I stop receiving Fentanyl Citrate Injection?
Can Fentanyl Citrate Injection cause constipation?
What should I do if I have trouble breathing after receiving Fentanyl Citrate Injection?
What are the common side effects of fentanyl?
Does fentanyl interact with other medications?
What drug class is fentanyl?
Is fentanyl safe during pregnancy?
Has fentanyl been recalled?
Is fentanyl currently in shortage?
Active Recalls
Subpotent Drug
IntegraDose Compounding Services LLC
cGMP deviations.
Wells Pharma of Houston LLC
cGMP deviations.
Wells Pharma of Houston LLC
cGMP deviations.
Wells Pharma of Houston LLC
cGMP deviations.
Wells Pharma of Houston LLC
cGMP deviations.
Wells Pharma of Houston LLC
Lack of Assurance of Sterility
QuVa Pharma, Inc.
Lack of Assurance of Sterility: leaking bags
IntegraDose Compounding Services LLC
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Denver Solutions, LLC DBA Leiters Health
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Denver Solutions, LLC DBA Leiters Health
Lack of Assurance of Sterility
Apollo Care, LLC
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for fentanyl
The FDA label for fentanyl (sold under brand names such as Duragesic, Actiq) classifies it as a prescription-only medication in the Opioid Analgesic class. Fentanyl Citrate Injection is used to manage pain during and after surgery. Official labeling lists 4 commonly reported side effects, including Nausea, Vomiting, Dizziness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 95,293 voluntary reports. The database also lists 28 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.72.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 12 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: September 24, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages