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Acetaminophen Side Effects

The most commonly reported side effects of acetaminophen include pain, drug dependence, and fatigue, based on 852,618 FDA adverse event reports from 2004 to 2025. 5.9% of reports found the drug to be ineffective.

Acetaminophen side effects

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

1
Pain6.6%56,558
2
Drug Dependence6.0%51,238
3
Drug Ineffective5.9%50,036
4
Fatigue5.5%47,170
5
Overdose5.4%46,060
6
Nausea5.0%42,835
7
Off Label Use4.8%40,533
8
Death4.5%38,706
9
Headache4.5%38,364
10
Diarrhoea3.9%33,476
11
Toxicity To Various Agents3.7%31,282
12
Dyspnoea3.5%30,121
13
Vomiting3.5%29,482
14
Arthralgia3.4%28,584
15
Dependence2.9%25,055

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

Report severity

75.5%Serious643,729 reports
32.4%Hospitalizations275,822 reports
14.7%Fatal125,290 reports

Seriousness is determined by the reporter, not by OpenClaim.

Acetaminophen drug interactions

Other drugs that appear in adverse event reports alongside acetaminophen. 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
Oxycodone14.1%120,585
2
Hydrocodone10.1%86,099
3
Morphine-sulfate6.4%54,301
4
Hydromorphone-hydrochloride5.9%49,910
5
Aspirin5.7%48,451
6
Fentanyl4.7%40,085
7
Buprenorphine4.6%39,627
8
Tramadol-hydrochloride4.3%36,382
9
Rituximab4.0%34,530
10
Oxymorphone-hydrochloride3.7%31,313
11
Adalimumab3.6%30,946
12
Ibuprofen3.5%29,585
13
Lenalidomide3.3%28,331
14
Tapentadol2.7%23,294
15
Infliximab2.6%21,927

Taken alongside

1
Hydrocodone11.9%101,168
2
Aspirin11.8%100,533
3
Ergocalciferol10.3%87,449
4
Omeprazole9.3%79,286
5
Oxycodone9.2%78,366
6
Diphenhydramine8.4%71,711
7
Levothyroxine-sodium8.3%70,930
8
Albuterol8.2%69,723
9
Furosemide7.9%67,471
10
Gabapentin7.7%66,066
11
Ibuprofen7.7%65,987
12
Prednisone7.5%63,799
13
Atorvastatin-calcium7.0%59,903
14
Ondansetron6.9%59,247
15
Pantoprazole-sodium6.8%58,183

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 acetaminophen side effects

54.4% of acetaminophen adverse event reports involve female patients and 32.2% involve male patients. The largest age group is adult at 56%. These figures reflect who reports side effects, not underlying risk.

Sex

Female54.4%
Male32.2%
Unknown13.4%

Age group

< 21.8%
2–112.4%
12–172.6%
18–6455.9%
65+37.4%

What is acetaminophen used for

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

Abdominal AbscessAbdominal AdhesionsAbdominal DiscomfortAbdominal DistensionAbdominal HerniaAbdominal MigraineAbdominal OperationAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbdominal RigidityAbnormal BehaviourAbnormal FaecesAbnormal Sensation In EyeAbortion Induced

Showing 15 of 3,754 indications

Acetaminophen brand names and reporting trend

Acetaminophen is sold under the brand name Vicodin Es.

Brand names

Vicodin Es421,202

Quarterly reports (20042025)

20052010201520202025

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

Taking acetaminophen with another medication?

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