Butalbital/acetaminophen/caffeine Capsules

  • Migraine and headache

Butalbital/acetaminophen/caffeine Capsules Generic Name & Formulations

General Description

Butalbital 50mg, acetaminophen 300mg, caffeine 40mg.

Pharmacological Class

Barbiturate + analgesic + methylxanthine.

How Supplied

Caps—contact supplier; Fioricet w. Codeine caps—100

Butalbital/acetaminophen/caffeine Capsules Indications


Tension (or muscle contraction) headache.

Butalbital/acetaminophen/caffeine Capsules Dosage and Administration


Use lowest effective dose for shortest duration. Individualize. 1–2 caps every 4hrs as needed; max 6 caps/day. Also with Codeine: concomitant use or discontinuation of CYP2D6 inhibitors, CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.


Not established.

Butalbital/acetaminophen/caffeine Capsules Contraindications


Porphyria. Also with Codeine: children <12yrs. Post-op management in children <18yrs following tonsillectomy and/or adenoidectomy. Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus. During or within 14 days of MAOIs.

Butalbital/acetaminophen/caffeine Capsules Boxed Warnings

Not Applicable

Butalbital/acetaminophen/caffeine Capsules Warnings/Precautions


Risk of hepatotoxicity (acetaminophen >4g/day). Discontinue at 1st sign of rash or any other hypersensitivity. Also with Codeine: assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Abuse potential (monitor). Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Risk of life-threatening respiratory depression and death related to ultra-rapid metabolizers of codeine (esp. in children for post-tonsillectomy and/or adenoidectomy pain). Avoid in adolescents 12–18yrs with conditions associated with hypoventilation (eg, post-op status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, concomitant drugs that cause respiratory depression). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Acute abdomen. Reevaluate periodically. Avoid abrupt cessation. Severe renal or hepatic impairment (monitor). Ultra-rapid metabolizers (due to CYP2D6 polymorphism): avoid. Drug abusers. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

Butalbital/acetaminophen/caffeine Capsules Pharmacokinetics

See Literature

Butalbital/acetaminophen/caffeine Capsules Interactions


Concomitant other acetaminophen-containing products: not recommended. Also with Codeine: increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor closely; consider prescribing naloxone if concomitant use is warranted. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. May be affected by CYP2D6 inhibitors (eg, amiodarone, quinidine, fluoxetine, paroxetine, bupropion). Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors, grapefruit juice). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. Codeine may increase serum amylase levels. Acetaminophen may cause false (+) urine test for 5-hydroxyindoleacetic acid.

Butalbital/acetaminophen/caffeine Capsules Adverse Reactions

Adverse Reactions

Drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, intoxicated feeling; hepatotoxicity, serious skin reactions or other hypersensitivity (rare). Also with Codeine: respiratory depression, severe hypotension, syncope.

Butalbital/acetaminophen/caffeine Capsules Clinical Trials

See Literature

Butalbital/acetaminophen/caffeine Capsules Note

Not Applicable

Butalbital/acetaminophen/caffeine Capsules Patient Counseling

See Literature