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Fentanyl Side Effects

The most commonly reported side effects of fentanyl include death, toxicity to various agents, and drug abuse, based on 188,102 FDA adverse event reports from 2004 to 2025. 5.0% of reports found the drug to be ineffective.

Fentanyl side effects

Percentages show how often each reaction appears relative to total reports for fentanyl.

1
Death10.3%19,464
2
Toxicity To Various Agents9.1%17,106
3
Drug Abuse7.4%13,906
4
Overdose7.3%13,749
5
Drug Ineffective5.0%9,482
6
Pain4.8%9,014
7
Drug Dependence4.4%8,303
8
Nausea3.2%5,957
9
Wrong Technique In Drug Usage Process2.8%5,315
10
Dependence2.4%4,496
11
Off Label Use2.3%4,373
12
Product Adhesion Issue2.3%4,359
13
Vomiting2.2%4,154
14
Fatigue2.2%4,099
15
Drug Withdrawal Syndrome2.0%3,807

These are voluntary reports and do not establish that fentanyl caused these reactions.

Report severity

79.6%Serious149,661 reports
27.0%Hospitalizations50,867 reports
32.6%Fatal61,251 reports

Seriousness is determined by the reporter, not by OpenClaim.

Fentanyl drug interactions

Other drugs that appear in adverse event reports alongside fentanyl. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Oxycodone21.0%39,471
2
Acetaminophen18.8%35,373
3
Morphine-sulfate16.3%30,625
4
Hydromorphone-hydrochloride15.5%29,126
5
Hydrocodone14.8%27,750
6
Oxymorphone-hydrochloride13.8%26,019
7
Buprenorphine13.6%25,665
8
Aspirin12.9%24,324
9
Tapentadol12.2%22,948
10
Ibuprofen4.4%8,279
11
Propofol3.2%5,928
12
Tramadol-hydrochloride3.1%5,776
13
Lenalidomide2.2%4,184
14
Amphetamine2.2%4,178
15
Apomorphine-hydrochloride2.2%4,157

Taken alongside

1
Acetaminophen11.8%22,249
2
Oxycodone8.8%16,582
3
Gabapentin5.6%10,568
4
Ondansetron5.5%10,411
5
Furosemide5.5%10,357
6
Omeprazole5.1%9,606
7
Aspirin5.1%9,602
8
Dexamethasone4.7%8,797
9
Pantoprazole-sodium4.6%8,639
10
Hydrocodone4.5%8,474
11
Levothyroxine-sodium4.5%8,398
12
Midazolam4.4%8,276
13
Propofol4.0%7,481
14
Lorazepam3.8%7,210
15
Hydromorphone-hydrochloride3.7%6,962

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports fentanyl side effects

43.3% of fentanyl adverse event reports involve female patients and 37.0% involve male patients. The largest age group is adult at 65%. These figures reflect who reports side effects, not underlying risk.

Sex

Female43.3%
Male37.0%
Unknown19.7%

Age group

< 22.6%
2–111.7%
12–171.7%
18–6465.4%
65+28.6%

What is fentanyl used for

Conditions and purposes for which patients were taking fentanyl when the adverse event was reported.

Abdominal AdhesionsAbdominal DiscomfortAbdominal HerniaAbdominal MassAbdominal NeoplasmAbdominal OperationAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbdominal SepsisAbdominoplastyAbortion InducedAbscess DrainageAbscess NeckAccelerated Hypertension

Showing 15 of 2,156 indications

Fentanyl brand names and reporting trend

Fentanyl is sold under brand names including Duragesic-50, Innovar, Ionsys.

Brand names

Duragesic-50147,346
Innovar20,403
Ionsys13

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking fentanyl with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.