FENTANYL CITRATE

N/A

Manufactured by Civica, Inc.

34,048 FDA adverse event reports analyzed

Last updated: 2026-04-14

About FENTANYL CITRATE

FENTANYL CITRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Civica, Inc.. The most commonly reported adverse reactions for FENTANYL CITRATE include DEPENDENCE, OVERDOSE, DEATH, DRUG ABUSE, TOXICITY TO VARIOUS AGENTS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FENTANYL CITRATE.

Top Adverse Reactions

DEPENDENCE3,935 reports
OVERDOSE2,441 reports
DEATH2,050 reports
DRUG ABUSE1,692 reports
TOXICITY TO VARIOUS AGENTS1,362 reports
ILL DEFINED DISORDER1,288 reports
CARDIAC ARREST871 reports
DRUG INEFFECTIVE709 reports
RESPIRATORY ARREST697 reports
DRUG HYPERSENSITIVITY627 reports
NAUSEA594 reports
PAIN572 reports
WRONG TECHNIQUE IN DRUG USAGE PROCESS487 reports
ACCIDENTAL OVERDOSE455 reports
OFF LABEL USE446 reports
VOMITING413 reports
HYPOTENSION405 reports
DRUG DEPENDENCE385 reports
DRUG INTERACTION369 reports
FOETAL EXPOSURE DURING PREGNANCY342 reports
DYSPNOEA340 reports
WITHDRAWAL SYNDROME336 reports
DEPRESSION327 reports
DRUG WITHDRAWAL SYNDROME NEONATAL320 reports
COMPLETED SUICIDE292 reports
SOMNOLENCE290 reports
ANXIETY280 reports
PYREXIA279 reports
CONSTIPATION278 reports
PRODUCT QUALITY ISSUE273 reports
HEADACHE268 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION260 reports
MALAISE256 reports
CARDIO RESPIRATORY ARREST242 reports
FATIGUE241 reports
DIARRHOEA239 reports
DYSPHAGIA230 reports
RESPIRATORY DEPRESSION229 reports
DRUG WITHDRAWAL SYNDROME218 reports
BACK PAIN208 reports
ABDOMINAL PAIN207 reports
DIZZINESS207 reports
WEIGHT DECREASED207 reports
UNRESPONSIVE TO STIMULI197 reports
PNEUMONIA195 reports
HYPERTENSION192 reports
BRADYCARDIA184 reports
ANAEMIA183 reports
ASTHENIA176 reports
OXYGEN SATURATION DECREASED175 reports
DEPRESSED LEVEL OF CONSCIOUSNESS172 reports
CONFUSIONAL STATE170 reports
TACHYCARDIA166 reports
PULMONARY OEDEMA165 reports
GASTROINTESTINAL DISORDER162 reports
PRODUCT ADHESION ISSUE162 reports
AGITATION158 reports
ASTHMA154 reports
ARTHRALGIA153 reports
SEROTONIN SYNDROME153 reports
SEPSIS147 reports
DEVELOPMENTAL DELAY146 reports
DELIRIUM145 reports
FALL145 reports
GASTROOESOPHAGEAL REFLUX DISEASE145 reports
LOSS OF CONSCIOUSNESS145 reports
PREMATURE BABY141 reports
INSOMNIA140 reports
ANAPHYLACTIC REACTION139 reports
LEARNING DISORDER139 reports
RESPIRATORY FAILURE139 reports
SPEECH DISORDER DEVELOPMENTAL138 reports
CONDITION AGGRAVATED137 reports
HYPERHIDROSIS135 reports
DRUG PRESCRIBING ERROR133 reports
PRURITUS131 reports
MATERNAL EXPOSURE DURING PREGNANCY130 reports
RENAL FAILURE130 reports
ACUTE KIDNEY INJURY129 reports
DECREASED APPETITE129 reports
COLITIS127 reports
COMA125 reports
VISUAL IMPAIRMENT123 reports
ERYTHEMA122 reports
CARDIAC DISORDER117 reports
HYPOXIA114 reports
INCORRECT ROUTE OF DRUG ADMINISTRATION114 reports
GAIT DISTURBANCE111 reports
PRODUCT USE IN UNAPPROVED INDICATION110 reports
BLOOD PRESSURE DECREASED109 reports
EMOTIONAL DISTRESS108 reports
RASH107 reports
MIOSIS104 reports
FEELING ABNORMAL103 reports
DISTURBANCE IN ATTENTION102 reports
PAIN IN EXTREMITY102 reports
SEIZURE102 reports
DYSPEPSIA101 reports
CHEST PAIN100 reports
RHABDOMYOLYSIS100 reports

Report Outcomes

Out of 17,548 classified reports for FENTANYL CITRATE:

Serious 88.3%Non-Serious 11.7%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male7,376 (51.3%)
Female6,866 (47.7%)
Unknown144 (1.0%)

Reports by Age

Age 37191 reports
Age 36186 reports
Age 50169 reports
Age 35163 reports
Age 65162 reports
Age 30160 reports
Age 32159 reports
Age 53159 reports
Age 57159 reports
Age 49156 reports
Age 63153 reports
Age 23149 reports
Age 58147 reports
Age 47142 reports
Age 44140 reports
Age 29139 reports
Age 52139 reports
Age 33137 reports
Age 31136 reports
Age 34136 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with FENTANYL CITRATE?

This profile reflects 34,048 FDA FAERS reports that mention FENTANYL CITRATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FENTANYL CITRATE?

Frequently reported terms in FAERS include DEPENDENCE, OVERDOSE, DEATH, DRUG ABUSE, TOXICITY TO VARIOUS AGENTS, ILL-DEFINED DISORDER. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FENTANYL CITRATE?

Labeling and FAERS entries often list Civica, Inc. in connection with FENTANYL CITRATE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.