BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE

N/A

Manufactured by Actavis Pharma, Inc.

24,476 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. The most commonly reported adverse reactions for BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE include HEADACHE, NAUSEA, DRUG INEFFECTIVE, FATIGUE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE.

Top Adverse Reactions

HEADACHE1,222 reports
NAUSEA960 reports
DRUG INEFFECTIVE854 reports
FATIGUE805 reports
PAIN768 reports
MIGRAINE732 reports
DIARRHOEA560 reports
DIZZINESS559 reports
VOMITING446 reports
DYSPNOEA441 reports
ANXIETY424 reports
FALL417 reports
DEPRESSION386 reports
MALAISE378 reports
INSOMNIA364 reports
ARTHRALGIA354 reports
BACK PAIN352 reports
FEELING ABNORMAL338 reports
ASTHENIA328 reports
WEIGHT DECREASED321 reports
OFF LABEL USE318 reports
PAIN IN EXTREMITY316 reports
DEATH283 reports
CHEST PAIN272 reports
COUGH263 reports
SINUSITIS258 reports
PNEUMONIA244 reports
WEIGHT INCREASED244 reports
ABDOMINAL PAIN UPPER239 reports
SOMNOLENCE239 reports
PYREXIA236 reports
RASH234 reports
CONSTIPATION233 reports
ABDOMINAL PAIN229 reports
INJECTION SITE PAIN226 reports
HYPERTENSION224 reports
DECREASED APPETITE223 reports
PRURITUS221 reports
CONDITION AGGRAVATED219 reports
PRODUCT DOSE OMISSION ISSUE217 reports
HYPOAESTHESIA216 reports
MUSCLE SPASMS214 reports
URINARY TRACT INFECTION213 reports
TREMOR211 reports
PARAESTHESIA210 reports
ALOPECIA185 reports
COMPLETED SUICIDE183 reports
DRUG HYPERSENSITIVITY183 reports
GAIT DISTURBANCE180 reports
MEMORY IMPAIRMENT166 reports
NASOPHARYNGITIS165 reports
TOXICITY TO VARIOUS AGENTS162 reports
BLOOD PRESSURE INCREASED161 reports
MYALGIA161 reports
VISION BLURRED155 reports
INJURY154 reports
BRONCHITIS151 reports
CONFUSIONAL STATE151 reports
HYPERSENSITIVITY150 reports
OVERDOSE148 reports
COVID 19146 reports
HYPERHIDROSIS146 reports
ABDOMINAL DISCOMFORT145 reports
DRUG DOSE OMISSION142 reports
LOSS OF CONSCIOUSNESS141 reports
CEREBROVASCULAR ACCIDENT139 reports
HYPOTENSION139 reports
ANAEMIA138 reports
EMOTIONAL DISTRESS135 reports
GASTROOESOPHAGEAL REFLUX DISEASE135 reports
ASTHMA134 reports
URTICARIA134 reports
BALANCE DISORDER131 reports
DEHYDRATION130 reports
PALPITATIONS130 reports
PERIPHERAL SWELLING130 reports
PULMONARY EMBOLISM130 reports
CONTUSION129 reports
NECK PAIN129 reports
SUICIDAL IDEATION129 reports
MUSCULAR WEAKNESS127 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS127 reports
CHILLS125 reports
INFLUENZA123 reports
ILLNESS122 reports
SEIZURE122 reports
ACUTE KIDNEY INJURY121 reports
STRESS121 reports
CHEST DISCOMFORT118 reports
OROPHARYNGEAL PAIN115 reports
DYSPEPSIA111 reports
FLUSHING109 reports
AMNESIA108 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION108 reports
INFLUENZA LIKE ILLNESS108 reports
OEDEMA PERIPHERAL107 reports
PRODUCT USE ISSUE107 reports
SWELLING107 reports
VISUAL IMPAIRMENT107 reports
INFECTION105 reports

Report Outcomes

Out of 10,441 classified reports for BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE:

Serious 56.7%Non-Serious 43.3%

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

Female8,387 (85.0%)
Male1,459 (14.8%)
Unknown24 (0.2%)

Reports by Age

Age 52173 reports
Age 58162 reports
Age 48161 reports
Age 51161 reports
Age 59161 reports
Age 63160 reports
Age 44159 reports
Age 53159 reports
Age 55159 reports
Age 56158 reports
Age 57155 reports
Age 54153 reports
Age 49146 reports
Age 50142 reports
Age 45139 reports
Age 46135 reports
Age 65134 reports
Age 47132 reports
Age 40131 reports
Age 41131 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 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE?

This profile reflects 24,476 FDA FAERS reports that mention BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE?

Frequently reported terms in FAERS include HEADACHE, NAUSEA, DRUG INEFFECTIVE, FATIGUE, PAIN, MIGRAINE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE?

Labeling and FAERS entries often list Actavis Pharma, Inc. in connection with BUTALBITAL, ACETAMINOPHEN, AND 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.