CAFFEINE

N/A

Manufactured by Kobayashi Healthcare International, Inc.

77,880 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CAFFEINE

CAFFEINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kobayashi Healthcare International, Inc.. The most commonly reported adverse reactions for CAFFEINE include TOXICITY TO VARIOUS AGENTS, FATIGUE, PAIN, OFF LABEL USE, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CAFFEINE.

Top Adverse Reactions

TOXICITY TO VARIOUS AGENTS1,329 reports
FATIGUE1,201 reports
PAIN1,077 reports
OFF LABEL USE1,038 reports
VOMITING1,014 reports
DRUG INEFFECTIVE1,011 reports
ALOPECIA1,001 reports
ARTHRALGIA996 reports
ABDOMINAL DISCOMFORT979 reports
CONDITION AGGRAVATED978 reports
DYSPNOEA969 reports
HEADACHE955 reports
NAUSEA955 reports
DIARRHOEA941 reports
ARTHROPATHY913 reports
HEPATIC ENZYME INCREASED902 reports
CONFUSIONAL STATE892 reports
PEMPHIGUS891 reports
PERICARDITIS889 reports
INFUSION RELATED REACTION888 reports
URTICARIA887 reports
ABDOMINAL PAIN UPPER882 reports
RASH882 reports
DIZZINESS874 reports
HAND DEFORMITY871 reports
MOBILITY DECREASED867 reports
STOMATITIS864 reports
JOINT SWELLING863 reports
DUODENAL ULCER PERFORATION862 reports
RHEUMATOID ARTHRITIS858 reports
NASOPHARYNGITIS855 reports
HELICOBACTER INFECTION853 reports
SWELLING853 reports
PYREXIA850 reports
DISCOMFORT848 reports
GENERAL PHYSICAL HEALTH DETERIORATION823 reports
GLOSSODYNIA822 reports
BLOOD CHOLESTEROL INCREASED819 reports
DRUG HYPERSENSITIVITY819 reports
BLISTER818 reports
SYSTEMIC LUPUS ERYTHEMATOSUS815 reports
HYPERSENSITIVITY814 reports
SYNOVITIS814 reports
WEIGHT INCREASED803 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE801 reports
FIBROMYALGIA798 reports
DRUG INTOLERANCE793 reports
SINUSITIS790 reports
ANXIETY787 reports
FOLLICULITIS786 reports
HYPERTENSION779 reports
ASTHENIA776 reports
LOWER RESPIRATORY TRACT INFECTION776 reports
PSORIATIC ARTHROPATHY773 reports
MUSCULOSKELETAL STIFFNESS771 reports
PRURITUS761 reports
CHEST PAIN759 reports
TYPE 2 DIABETES MELLITUS754 reports
MATERNAL EXPOSURE DURING PREGNANCY748 reports
OEDEMA742 reports
MUSCLE INJURY737 reports
WOUND737 reports
IMPAIRED HEALING734 reports
ASTHMA730 reports
PERIPHERAL SWELLING730 reports
CONTUSION726 reports
INJURY719 reports
LIVER INJURY719 reports
IRRITABLE BOWEL SYNDROME718 reports
DECREASED APPETITE711 reports
HYPOAESTHESIA707 reports
GASTROINTESTINAL DISORDER704 reports
INSOMNIA701 reports
RHEUMATOID FACTOR POSITIVE701 reports
MALAISE690 reports
INFECTION671 reports
DEEP VEIN THROMBOSIS POSTOPERATIVE653 reports
AUTOIMMUNE DISORDER652 reports
ROAD TRAFFIC ACCIDENT652 reports
WHEEZING648 reports
C REACTIVE PROTEIN ABNORMAL635 reports
TREATMENT FAILURE632 reports
LOWER LIMB FRACTURE605 reports
OSTEOARTHRITIS604 reports
DRY MOUTH595 reports
RHEUMATIC FEVER594 reports
PNEUMONIA579 reports
CONTRAINDICATED PRODUCT ADMINISTERED571 reports
SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE563 reports
SWOLLEN JOINT COUNT INCREASED559 reports
SLEEP DISORDER558 reports
GAIT INABILITY550 reports
SCIATICA549 reports
LIVER DISORDER544 reports
BURSITIS541 reports
PRODUCT USE IN UNAPPROVED INDICATION533 reports
PRODUCT USE ISSUE530 reports
OVERDOSE527 reports
MUSCULOSKELETAL PAIN524 reports
ABDOMINAL PAIN518 reports

Report Outcomes

Out of 7,451 classified reports for CAFFEINE:

Serious 88.9%Non-Serious 11.1%

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

Female4,316 (64.7%)
Male2,333 (35.0%)
Unknown18 (0.3%)

Reports by Age

Age 44605 reports
Age 43567 reports
Age 37127 reports
Age 38113 reports
Age 50110 reports
Age 77106 reports
Age 48105 reports
Age 3399 reports
Age 5392 reports
Age 2891 reports
Age 4290 reports
Age 3089 reports
Age 3186 reports
Age 3285 reports
Age 3984 reports
Age 4084 reports
Age 5284 reports
Age 2983 reports
Age 2181 reports
Age 4575 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 CAFFEINE?

This profile reflects 77,880 FDA FAERS reports that mention CAFFEINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CAFFEINE?

Frequently reported terms in FAERS include TOXICITY TO VARIOUS AGENTS, FATIGUE, PAIN, OFF LABEL USE, VOMITING, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CAFFEINE?

Labeling and FAERS entries often list Kobayashi Healthcare International, Inc. in connection with CAFFEINE. 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.