Butalbital/Acetaminophen/Caffeine

Butalbital/Acetaminophen/Caffeine is a prescription medication used to treat Tension Headaches.  

• Butalbital/Acetaminophen/Caffeine is available under the following different brand names: Fioricet, Orbivan, Alagesic LQ, Dolgic Plus, Esgic Plus, Margesic, Zebutal

Adult and pediatric dosage

Tablet

• butalbital/acetaminophen/caffeine
• 50mg/325mg/40mg (Fioricet, Esgic)
• 50mg/500mg/40mg (Espic-Plus)
• 50mg/750mg/40mg (Dolgic Plus)

Capsule

• butalbital/acetaminophen/caffeine
• 50mg/300mg/40mg (Orbivan)
• 50mg/325mg/40mg (Esgic, Margesic)
• 50mg/500mg/40mg (Esgic-Plus, Zebutal)

Liquid, oral

• butalbital/acetaminophen/caffeine
• (50mg/325mg/40mg)15mL (Alagesic LQ)

Tension Headache

Adult dosage

• 50mg/300-325mg/40mg: 2 tablets or capsules orally every 4 hours; not to exceed 6 tablets or capsules/day 
• 50mg/500mg/40mg: 1 tablet/capsule orally every 4 hours; not to exceed 6 tablets or capsules/day 
• 50mg/750mg/40mg: 1 tablet/capsule orally every 4 hours; not to exceed 5 tablets or capsules/day
• 15-30 mL solution orally every 4 hours; not to exceed 180 mL solution/day
• Not to exceed 4 g/day of acetaminophen for any dosage form or regimen 

Pediatric dosage

• Children younger than 12 years of age: Safety and efficacy not established
• Children 12 years of age or older:
  • 50mg/300-325mg/40mg: 2 tablets or capsules orally every 4 hours; not to exceed 6 tablets or capsules/day
  • 50mg/500mg/40mg: 1 tablet/capsule orally every 4 hours; not to exceed 6 tablets or capsules/day
  • 50mg/750mg/40mg: 1 tablet/capsule orally every 4 hours; not to exceed 5 tablets or capsules/day
  • 15-30 mL solution orally every 4 hours; not to exceed 90 mL solution/day
  • Not to exceed 4 g/day of acetaminophen for any dosage form or regimen

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Butalbital/Acetaminophen/Caffeine include:

• drowsiness, 
• dizziness, 
• feeling “drunk”, 
• headache, 
• tiredness, 
• nausea, 
• vomiting, 
• stomach pain, and
• constipation

Serious side effects of Butalbital/Acetaminophen/Caffeine include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• skin redness, 
• rash that spreads and causes blistering and peeling, 
• slow breathing with long pauses, 
• blue colored lips, 
• difficult to arouse, 
• noisy breathing, 
• sighing, 
• shallow breathing, 
• slow heart rate, 
• weak pulse, 
• extreme drowsiness, 
• lightheadedness, 
• chest pain, 
• fast or pounding heart rate, 
• shortness of breath, 
• confusion, 
• unusual thoughts or behavior, 
• agitation, 
• hallucinations, 
• fever, 
• sweating, 
• shivering, 
• fast heart rate, 
• muscle stiffness, 
• twitching, 
• loss of coordination, 
• nausea, 
• vomiting, 
• diarrhea, 
• loss of appetite, 
• dizziness, 
• worsening tiredness, 
• weakness, 
• upper stomach pain, 
• itching, 
• dark urine, 
• clay-colored stools, and
• yellowing of the skin or eyes (jaundice)

Rare side effects of Butalbital/Acetaminophen/Caffeine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Butalbital/Acetaminophen/Caffeine has severe interactions with the following drugs:
  • doravirine
  • fostemsavir
  • isavuconazonium sulfate
  • isocaboxazid
  • linezolid
  • lonafarnib
  • lorlatinib
  • pheneizine
• Butalbital/Acetaminophen/Caffeine has severe interactions with at least 70 other drugs. 
• Butalbital/Acetaminophen/Caffeine has moderate interactions with at least 384 other drugs. 
• Butalbital/Acetaminophen/Caffeine has minor interactions with at least 190 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist about all the medicines you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Butalbital/Acetaminophen/Caffeine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Butalbital/Acetaminophen/Caffeine?”

Cautions

• Use caution in hepatitis or severe hepatic/renal impairment
• Use caution in repeated administration to patients with anemia, or with cardiovascular, pulmonary, or renal disease porphyria
• Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplantation or death; risk increases in individuals with underlying liver disease, alcohol ingestion, and/or use of more than 1 acetaminophen-containing product (see Black Box Warnings)
• Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters, and rash
• Patients with G6PD deficiency
• Butalbital may cause sedation; avoid driving a car, operating machinery, or administering with other CNS depressants (eg, alcohol)
• Caution with special-risk patients (eg, elderly or debilitated or those with severe renal or hepatic dysfunction or with acute abdominal conditions)

Overuse of barbiturate-containing medications

• Based on the American Academy of Neurology guidelines, limit and carefully monitor the use of butalbital-containing agents
• Don’t use opioid or butalbital treatment for migraine except as a last resort
• Any use of barbiturates and opiates was associated with an increased risk of transformed migraine after adjusting for covariates
• Limit and carefully monitor their use (butalbital-containing agents) based on overuse, medication overuse headache, and withdrawal concerns
• Butalbital may be habit-forming; for short-term use only

Pregnancy and Lactation

• Case reports of withdrawal seizures in newborns whose mothers had taken butalbital-containing drugs during pregnancy.
• Lactation: Excreted in breast milk in small amounts; not recommended.