What are the contraindications of Fioricet (Butalbital, Acetaminophen, and Caffeine)?

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From the Guidelines

Fiorcet is contraindicated in patients with a history of barbiturate addiction, porphyria, severe liver disease, or hypersensitivity to any of its ingredients, and its use should be avoided in patients with kidney impairment, severe cardiovascular disease, and those taking MAO inhibitors or with a history of angle-closure glaucoma. The medication's components, including butalbital, acetaminophen, and caffeine, contribute to its contraindications. Butalbital can cause physical dependence and respiratory depression, while acetaminophen can cause liver damage in high doses 1. Caffeine may exacerbate certain cardiovascular conditions. According to the Mayo Clinic Proceedings, butalbital should not be stopped abruptly before surgery if it is used long-term, and it should be weaned over 2 weeks to avoid acute withdrawal 1. The CDC clinical practice guideline for prescribing opioids for pain also emphasizes the risks of opioid use disorder, respiratory depression, and death at higher dosages, and recommends against prescribing opioid or butalbital-containing medications as first-line treatment for recurrent headache disorders 1. Key considerations for the use of Fiorcet include:

  • Avoiding its use in patients with a history of substance abuse or dependence
  • Monitoring patients for signs of physical dependence or addiction
  • Using the medication with caution in patients with kidney or liver impairment
  • Avoiding concurrent use with MAO inhibitors or other medications that may interact with Fiorcet
  • Educating patients about the risks and benefits of Fiorcet, including the potential for dependence and overdose. Overall, the use of Fiorcet should be carefully considered and monitored in patients with certain medical conditions or a history of substance abuse, and alternative treatments should be explored when possible.

From the FDA Drug Label

INDICATIONS AND USAGE Butalbital, Acetaminophen and Caffeine Capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. The FDA drug label does not answer the question.

From the Research

Fiorcet Contraindications

  • Fiorcet is a combination medication containing butalbital, acetaminophen, and caffeine, commonly used to treat tension headaches 2.
  • Medication overuse headache is a potential contraindication for Fiorcet, as it can exacerbate chronic daily headache in migraine patients 2.
  • The following are potential contraindications for Fiorcet:
    • Medication overuse headache
    • Chronic daily headache
    • Migraine patients with a history of medication overuse
  • It is essential to carefully evaluate the patient's medical history and current medications before prescribing Fiorcet 2.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Medication Overuse Headache Due to Butalbital, Acetaminophen, and Caffeine Tablets.

Journal of pain & palliative care pharmacotherapy, 2016

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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