Drug
Butalbital, Acetaminophen, And Caffeine Capsules
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Infusion Site Pain | 25 | 23.0 | 23.3 | signal |
| 2 | Completed Suicide | 153 | 21.3 | 23.2 | signal |
| 3 | Hepatotoxicity | 25 | 13.2 | 13.4 | signal |
| 4 | Metabolic Acidosis | 35 | 13.0 | 13.2 | signal |
| 5 | Migraine | 101 | 12.5 | 13.2 | signal |
| 6 | Respiratory Depression | 13 | 12.4 | 12.5 | signal |
| 7 | Dermatitis Contact | 12 | 12.4 | 12.5 | signal |
| 8 | Coagulopathy | 17 | 12.0 | 12.1 | signal |
| 9 | Poisoning | 11 | 10.2 | 10.3 | signal |
| 10 | Poisoning Deliberate | 8 | 10.1 | 10.1 | signal |
| 11 | Vitamin D Deficiency | 8 | 9.6 | 9.7 | signal |
| 12 | Toxicity To Various Agents | 137 | 9.6 | 10.3 | signal |
| 13 | Adrenal Insufficiency | 9 | 8.8 | 8.9 | signal |
| 14 | Fibromyalgia | 18 | 8.7 | 8.8 | signal |
| 15 | Product Use Complaint | 11 | 8.3 | 8.4 | signal |
| 16 | Dry Throat | 7 | 8.1 | 8.1 | signal |
| 17 | Pharyngitis Streptococcal | 7 | 7.6 | 7.6 | signal |
| 18 | Intervertebral Disc Degeneration | 6 | 7.6 | 7.6 | signal |
| 19 | Pharyngeal Swelling | 6 | 7.3 | 7.4 | signal |
| 20 | Cholecystectomy | 7 | 7.2 | 7.2 | signal |
| 21 | Depressed Level Of Consciousness | 24 | 7.1 | 7.2 | signal |
| 22 | Economic Problem | 9 | 6.8 | 6.9 | signal |
| 23 | Weight Fluctuation | 6 | 6.7 | 6.8 | signal |
| 24 | Cardio-respiratory Arrest | 24 | 6.7 | 6.8 | signal |
| 25 | Ear Infection | 15 | 6.6 | 6.7 | signal |
| 26 | Respiratory Arrest | 15 | 6.3 | 6.4 | signal |
| 27 | Insurance Issue | 8 | 6.3 | 6.3 | signal |
| 28 | Tooth Infection | 7 | 6.2 | 6.2 | signal |
| 29 | Spinal Disorder | 5 | 6.2 | 6.2 | signal |
| 30 | Carpal Tunnel Syndrome | 7 | 5.8 | 5.9 | signal |
| 31 | Brain Injury | 5 | 5.8 | 5.9 | signal |
| 32 | Poor Venous Access | 5 | 5.7 | 5.7 | signal |
| 33 | Coma | 23 | 5.7 | 5.7 | signal |
| 34 | Musculoskeletal Discomfort | 8 | 5.4 | 5.5 | signal |
| 35 | Pulmonary Thrombosis | 5 | 5.4 | 5.4 | signal |
| 36 | Tooth Fracture | 5 | 5.3 | 5.3 | signal |
| 37 | Feeding Disorder | 9 | 5.3 | 5.3 | signal |
| 38 | Restless Legs Syndrome | 8 | 5.1 | 5.2 | signal |
| 39 | Hepatitis | 11 | 5.0 | 5.1 | signal |
| 40 | Myoclonus | 5 | 4.9 | 4.9 | signal |
| 41 | Affect Lability | 4 | 4.8 | 4.9 | signal |
| 42 | Spinal Operation | 5 | 4.8 | 4.9 | signal |
| 43 | Coeliac Disease | 4 | 4.8 | 4.8 | signal |
| 44 | Sneezing | 9 | 4.7 | 4.7 | signal |
| 45 | Pelvic Pain | 7 | 4.5 | 4.5 | signal |
| 46 | Complication Associated With Device | 5 | 4.4 | 4.4 | signal |
| 47 | Anhedonia | 10 | 4.4 | 4.4 | signal |
| 48 | Respiratory Tract Congestion | 6 | 4.4 | 4.4 | signal |
| 49 | Acute Hepatic Failure | 5 | 4.3 | 4.3 | signal |
| 50 | Back Disorder | 6 | 4.3 | 4.3 | signal |
| 51 | Drug Level Increased | 6 | 4.2 | 4.3 | signal |
| 52 | Hepatocellular Injury | 5 | 4.1 | 4.1 | signal |
| 53 | Tooth Extraction | 4 | 3.8 | 3.8 | signal |
| 54 | Eructation | 6 | 3.7 | 3.7 | signal |
| 55 | Disability | 6 | 3.6 | 3.6 | signal |
| 56 | Product Physical Issue | 6 | 3.5 | 3.5 | signal |
| 57 | Device Dislocation | 13 | 3.5 | 3.5 | signal |
| 58 | Hunger | 4 | 3.5 | 3.5 | signal |
| 59 | Product Taste Abnormal | 4 | 3.5 | 3.5 | signal |
| 60 | Injection Site Urticaria | 7 | 3.4 | 3.4 | signal |
| 61 | Hereditary Angioedema | 3 | 3.3 | 3.4 | no signal |
| 62 | Overdose | 59 | 3.2 | 3.3 | signal |
| 63 | Bone Loss | 4 | 3.1 | 3.1 | no signal |
| 64 | Suicide Attempt | 16 | 3.1 | 3.1 | signal |
| 65 | Serotonin Syndrome | 5 | 3.1 | 3.1 | signal |
| 66 | Product Dose Omission In Error | 7 | 3.1 | 3.1 | signal |
| 67 | Unintentional Medical Device Removal | 3 | 3.0 | 3.0 | no signal |
| 68 | Bone Density Decreased | 8 | 3.0 | 3.0 | signal |
| 69 | Hepatitis C | 3 | 2.9 | 2.9 | no signal |
| 70 | Hair Colour Changes | 3 | 2.8 | 2.8 | no signal |
| 71 | Intentional Drug Misuse | 5 | 2.8 | 2.8 | no signal |
| 72 | Emotional Distress | 25 | 2.4 | 2.4 | signal |
| 73 | Dystonia | 4 | 2.4 | 2.4 | no signal |
| 74 | Device Failure | 3 | 2.3 | 2.3 | no signal |
| 75 | Product Substitution Issue | 11 | 2.2 | 2.2 | signal |
| 76 | Pharmaceutical Product Complaint | 5 | 2.2 | 2.2 | no signal |
| 77 | Product Dispensing Error | 4 | 2.2 | 2.2 | no signal |
| 78 | Withdrawal Syndrome | 7 | 1.9 | 1.9 | no signal |
| 79 | Drug Effect Decreased | 9 | 1.9 | 1.9 | no signal |
| 80 | Vaginal Haemorrhage | 7 | 1.9 | 1.9 | no signal |
| 81 | Therapeutic Response Shortened | 5 | 1.8 | 1.8 | no signal |
| 82 | Device Breakage | 6 | 1.8 | 1.8 | no signal |
| 83 | Multiple Sclerosis Relapse | 10 | 1.7 | 1.7 | no signal |
| 84 | Device Leakage | 6 | 1.7 | 1.7 | no signal |
| 85 | Tardive Dyskinesia | 4 | 1.6 | 1.6 | no signal |
| 86 | Exposure Via Skin Contact | 3 | 1.6 | 1.6 | no signal |
| 87 | Drug Abuse | 11 | 1.5 | 1.5 | no signal |
| 88 | Injection Site Pruritus | 8 | 1.4 | 1.4 | no signal |
| 89 | Extrapyramidal Disorder | 3 | 1.4 | 1.4 | no signal |
| 90 | Dependence | 5 | 1.1 | 1.1 | no signal |
| 91 | Product Adhesion Issue | 3 | 1.0 | 1.0 | no signal |
| 92 | Drug Dependence | 13 | 0.9 | 0.9 | no signal |
| 93 | Device Difficult To Use | 4 | 0.7 | 0.7 | no signal |