ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE

N/A

Manufactured by OPMX LLC

712 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE

ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by OPMX LLC. The most commonly reported adverse reactions for ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE include ABDOMINAL PAIN, VOMITING, DIARRHOEA, NAUSEA, MUCOSAL INFLAMMATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE.

Top Adverse Reactions

ABDOMINAL PAIN22 reports
VOMITING22 reports
DIARRHOEA18 reports
NAUSEA18 reports
MUCOSAL INFLAMMATION15 reports
PAIN15 reports
ABDOMINAL PAIN UPPER14 reports
ASTHENIA14 reports
INSOMNIA13 reports
DIZZINESS12 reports
MALAISE12 reports
DECREASED APPETITE11 reports
GASTRITIS11 reports
PAIN IN EXTREMITY11 reports
CONSTIPATION10 reports
HEADACHE10 reports
PYREXIA10 reports
COUGH9 reports
HYPERSENSITIVITY9 reports
TACHYCARDIA9 reports
WEIGHT DECREASED9 reports
ABDOMINAL DISCOMFORT8 reports
ANXIETY8 reports
CATARACT8 reports
DRUG INEFFECTIVE8 reports
DYSPNOEA8 reports
FEELING ABNORMAL8 reports
PRURITUS8 reports
ALOPECIA7 reports
ANAEMIA7 reports
DISCOMFORT7 reports
DYSURIA7 reports
FEBRILE NEUTROPENIA7 reports
FLATULENCE7 reports
GENERAL PHYSICAL HEALTH DETERIORATION7 reports
TREMOR7 reports
VISUAL IMPAIRMENT7 reports
ABDOMINAL DISTENSION6 reports
BACK PAIN6 reports
BONE PAIN6 reports
CHEST PAIN6 reports
DEATH6 reports
ERYTHEMA6 reports
EYE PAIN6 reports
FATIGUE6 reports
HAEMOGLOBIN DECREASED6 reports
INFLUENZA6 reports
LIP DRY6 reports
OROPHARYNGEAL PAIN6 reports
PLATELET COUNT DECREASED6 reports
PRODUCT USE IN UNAPPROVED INDICATION6 reports
RASH6 reports
SKIN ULCER6 reports
TONGUE DRY6 reports
URINARY TRACT INFECTION6 reports
ARTHRALGIA5 reports
ARTHRITIS5 reports
BLISTER5 reports
BLOOD PRESSURE INCREASED5 reports
BURNING SENSATION5 reports
CONTUSION5 reports
CYSTITIS5 reports
DRUG INTOLERANCE5 reports
DRY EYE5 reports
DYSPHONIA5 reports
EYE IRRITATION5 reports
FOOD INTOLERANCE5 reports
GAIT INABILITY5 reports
GLAUCOMA5 reports
HEPATOTOXICITY5 reports
HYPERHIDROSIS5 reports
INCORRECT DOSE ADMINISTERED5 reports
INFLAMMATION5 reports
LACRIMATION INCREASED5 reports
LIMB DISCOMFORT5 reports
MATERNAL EXPOSURE DURING PREGNANCY5 reports
METASTASES TO LIVER5 reports
MUSCLE SPASMS5 reports
MYOPIA5 reports
OCULAR HYPERAEMIA5 reports
OFF LABEL USE5 reports
SKIN EXFOLIATION5 reports
STOMATITIS5 reports
THROMBOCYTOPENIA5 reports
TONGUE BLISTERING5 reports
TRANSAMINASES INCREASED5 reports
ABSCESS LIMB4 reports
ANAL INFLAMMATION4 reports
ANORECTAL SWELLING4 reports
BALANCE DISORDER4 reports
BASAL GANGLIA HAEMORRHAGE4 reports
BLOOD ALKALINE PHOSPHATASE INCREASED4 reports
BLOOD BILIRUBIN ABNORMAL4 reports
BLOOD CHROMOGRANIN A INCREASED4 reports
BLOOD CREATININE ABNORMAL4 reports
BREAST MASS4 reports
CHOLELITHIASIS4 reports
CONJUNCTIVITIS4 reports
DEVICE OCCLUSION4 reports
DRY MOUTH4 reports

Report Outcomes

Out of 148 classified reports for ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE:

Serious 97.3%Non-Serious 2.7%

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

Female91 (63.6%)
Male52 (36.4%)

Reports by Age

Age 616 reports
Age 385 reports
Age 645 reports
Age 725 reports
Age 775 reports
Age 524 reports
Age 734 reports
Age 754 reports
Age 804 reports
Age 193 reports
Age 423 reports
Age 593 reports
Age 603 reports
Age 653 reports
Age 793 reports
Age 883 reports
Age 142 reports
Age 352 reports
Age 362 reports
Age 402 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 ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE?

This profile reflects 712 FDA FAERS reports that mention ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE?

Frequently reported terms in FAERS include ABDOMINAL PAIN, VOMITING, DIARRHOEA, NAUSEA, MUCOSAL INFLAMMATION, PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE?

Labeling and FAERS entries often list OPMX LLC in connection with ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE. 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.