CAFFEINE CITRATE

N/A

Manufactured by Hikma Pharmaceuticals USA Inc.

60,859 FDA adverse event reports analyzed

Last updated: 2026-04-15

About CAFFEINE CITRATE

CAFFEINE CITRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Hikma Pharmaceuticals USA Inc.. The most commonly reported adverse reactions for CAFFEINE CITRATE include PEMPHIGUS, PERICARDITIS, HEPATIC ENZYME INCREASED, ALOPECIA, GLOSSODYNIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CAFFEINE CITRATE.

Top Adverse Reactions

PEMPHIGUS947 reports
PERICARDITIS912 reports
HEPATIC ENZYME INCREASED900 reports
ALOPECIA896 reports
GLOSSODYNIA890 reports
PAIN883 reports
JOINT SWELLING882 reports
HAND DEFORMITY874 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE870 reports
ARTHROPATHY865 reports
RHEUMATOID ARTHRITIS864 reports
FATIGUE854 reports
ABDOMINAL DISCOMFORT847 reports
SYSTEMIC LUPUS ERYTHEMATOSUS843 reports
DISCOMFORT840 reports
WOUND840 reports
HYPERSENSITIVITY823 reports
SYNOVITIS818 reports
INFUSION RELATED REACTION816 reports
RASH806 reports
RHEUMATOID FACTOR POSITIVE799 reports
DUODENAL ULCER PERFORATION792 reports
ARTHRALGIA779 reports
HELICOBACTER INFECTION779 reports
SWELLING776 reports
CONDITION AGGRAVATED757 reports
GENERAL PHYSICAL HEALTH DETERIORATION738 reports
BLISTER730 reports
OFF LABEL USE720 reports
INJURY718 reports
DRUG INEFFECTIVE717 reports
BLOOD CHOLESTEROL INCREASED714 reports
LIVER INJURY712 reports
PSORIATIC ARTHROPATHY686 reports
MOBILITY DECREASED679 reports
HEADACHE678 reports
MUSCULOSKELETAL STIFFNESS672 reports
HYPERTENSION667 reports
DRUG INTOLERANCE663 reports
TYPE 2 DIABETES MELLITUS657 reports
DECREASED APPETITE646 reports
MATERNAL EXPOSURE DURING PREGNANCY644 reports
RHEUMATIC FEVER644 reports
FIBROMYALGIA643 reports
HYPOAESTHESIA637 reports
DIARRHOEA634 reports
TREATMENT FAILURE614 reports
MALAISE611 reports
INFECTION585 reports
CONTRAINDICATED PRODUCT ADMINISTERED561 reports
NASOPHARYNGITIS561 reports
PRODUCT USE ISSUE559 reports
LOWER RESPIRATORY TRACT INFECTION554 reports
IMPAIRED HEALING548 reports
FOLLICULITIS546 reports
DRUG HYPERSENSITIVITY540 reports
WEIGHT INCREASED539 reports
CONFUSIONAL STATE538 reports
STOMATITIS538 reports
NAUSEA535 reports
OEDEMA532 reports
DYSPNOEA531 reports
URTICARIA525 reports
SWOLLEN JOINT COUNT INCREASED522 reports
THERAPEUTIC PRODUCT EFFECT DECREASED521 reports
PYREXIA517 reports
MUSCLE INJURY514 reports
SINUSITIS513 reports
PERIPHERAL SWELLING510 reports
IRRITABLE BOWEL SYNDROME509 reports
ABDOMINAL PAIN UPPER508 reports
CONTUSION501 reports
VOMITING473 reports
HYPERCHOLESTEROLAEMIA466 reports
CHEST PAIN451 reports
INTENTIONAL PRODUCT USE ISSUE450 reports
GAIT DISTURBANCE445 reports
PRURITUS445 reports
GASTROINTESTINAL DISORDER443 reports
ILL DEFINED DISORDER435 reports
MIGRAINE433 reports
DYSPEPSIA429 reports
PNEUMONIA429 reports
PRODUCT USE IN UNAPPROVED INDICATION428 reports
WHEEZING428 reports
PAIN IN EXTREMITY419 reports
JOINT RANGE OF MOTION DECREASED404 reports
PULMONARY FIBROSIS385 reports
DIZZINESS384 reports
SLEEP DISORDER376 reports
SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE376 reports
MEMORY IMPAIRMENT368 reports
ADJUSTMENT DISORDER WITH DEPRESSED MOOD363 reports
AMNESIA357 reports
ADVERSE EVENT356 reports
ASTHENIA350 reports
DELIRIUM349 reports
DISLOCATION OF VERTEBRA345 reports
OSTEOARTHRITIS345 reports
C REACTIVE PROTEIN ABNORMAL344 reports

Report Outcomes

Out of 2,137 classified reports for CAFFEINE CITRATE:

Serious 96.4%Non-Serious 3.6%

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

Female1,433 (84.5%)
Male257 (15.2%)
Unknown6 (0.4%)

Reports by Age

Age 43310 reports
Age 44269 reports
Age 59145 reports
Age 9763 reports
Age 052 reports
Age 5049 reports
Age 3930 reports
Age 122 reports
Age 4817 reports
Age 7716 reports
Age 513 reports
Age 2512 reports
Age 811 reports
Age 4111 reports
Age 1010 reports
Age 5310 reports
Age 69 reports
Age 249 reports
Age 499 reports
Age 48 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 CITRATE?

This profile reflects 60,859 FDA FAERS reports that mention CAFFEINE CITRATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CAFFEINE CITRATE?

Frequently reported terms in FAERS include PEMPHIGUS, PERICARDITIS, HEPATIC ENZYME INCREASED, ALOPECIA, GLOSSODYNIA, PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CAFFEINE CITRATE?

Labeling and FAERS entries often list Hikma Pharmaceuticals USA Inc. in connection with CAFFEINE 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.