OpenClaim

Caffeine Side Effects

The most commonly reported side effects of caffeine include product use in unapproved indication, headache, and fatigue, based on 46,546 FDA adverse event reports from 2004 to 2025. 12.6% of reports found the drug to be ineffective.

Caffeine side effects

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

1
Drug Ineffective12.6%5,849
2
Product Use In Unapproved Indication10.5%4,874
3
Headache8.1%3,784
4
Fatigue7.4%3,438
5
Pain7.3%3,399
6
Drug Effective For Unapproved Indication7.2%3,341
7
Nausea6.7%3,129
8
Off Label Use5.2%2,440
9
Diarrhoea5.0%2,348
10
Arthralgia4.8%2,213
11
Abdominal Discomfort4.7%2,184
12
Vomiting4.7%2,183
13
Dyspnoea4.6%2,120
14
Dizziness4.5%2,088
15
Migraine4.4%2,062

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

Report severity

54.7%Serious25,452 reports
21.0%Hospitalizations9,795 reports
11.7%Fatal5,459 reports

Seriousness is determined by the reporter, not by OpenClaim.

Caffeine drug interactions

Other drugs that appear in adverse event reports alongside caffeine. 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
Acetaminophen42.7%19,878
2
Aspirin31.2%14,524
3
Oxycodone7.5%3,482
4
Adalimumab7.0%3,281
5
Etanercept5.8%2,698
6
Abatacept5.5%2,555
7
Methotrexate5.3%2,482
8
Diclofenac5.3%2,477
9
Prednisone5.3%2,471
10
Infliximab5.1%2,380
11
Certolizumab-pegol5.0%2,345
12
Rituximab5.0%2,327
13
Sodium-oxybate5.0%2,325
14
Leflunomide5.0%2,320
15
Tocilizumab4.9%2,302

Taken alongside

1
Acetaminophen45.5%21,169
2
Aspirin25.1%11,674
3
Butalbital24.3%11,311
4
Codeine18.0%8,388
5
Ergocalciferol14.0%6,515
6
Ibuprofen11.9%5,558
7
Levothyroxine-sodium8.9%4,156
8
Albuterol7.9%3,682
9
Pantoprazole-sodium7.7%3,570
10
Lisinopril7.3%3,394
11
Gabapentin7.1%3,308
12
Lorazepam7.0%3,237
13
Omeprazole6.8%3,167
14
Ondansetron6.3%2,939
15
Fluticasone5.8%2,692

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 caffeine side effects

61.6% of caffeine adverse event reports involve female patients and 19.2% involve male patients. The largest age group is adult at 73%. These figures reflect who reports side effects, not underlying risk.

Sex

Female61.6%
Male19.2%
Unknown19.2%

Age group

< 22.9%
2–110.6%
12–171.7%
18–6473.2%
65+21.5%

What is caffeine used for

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

Abdominal DiscomfortAbdominal DistensionAbdominal MigraineAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbortionAbortion InducedAccident At WorkAccidental Drug Intake By ChildAccidental ExposureAcute Coronary SyndromeAcute LeukaemiaAcute Myeloid LeukaemiaAdcy5-related Dyskinesia

Showing 15 of 719 indications

Caffeine brand names and reporting trend

Caffeine is sold under brand names including Triad, Cafcit.

Brand names

Triad9,772
Cafcit2,497

Quarterly reports (20042025)

20052010201520202025

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

Taking caffeine with another medication?

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