Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary.
Fioricet is a combination medication commonly prescribed to treat tension headaches and migraine symptoms. It contains three active ingredients:
- Butalbital (a barbiturate): A central nervous system depressant that helps relax muscle tension and calm anxiety.
- Acetaminophen (analgesic and antipyretic): Relieves pain and reduces fever.
- Caffeine (a central nervous system stimulant): Enhances the pain-relieving effects of acetaminophen and may help improve blood flow.
BUTALBITAL; ACETAMINOPHEN; CAFFEINE treats tension headaches. It works by reducing pain. It also helps you relax. It is not used to prevent headaches or migraines. It is a combination of a barbiturate, acetaminophen, and caffeine.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
COMMON BRAND NAME(S): Alagesic, Americet, Anolor-300, Arcet, BAC, CAPACET, Dolgic Plus, Esgic, Esgic Plus, Ezol, Fioricet, Geone, Margesic, Medigesic, Orbivan, Pacaps, Phrenilin Forte, Repan, Tenake, Triad, Zebutal
Fioricet is primarily prescribed for:
- Tension-type headaches: Chronic or acute headaches caused by muscle tension and stress.
- Migraine relief (off-label): Though not specifically FDA-approved for migraines, Fioricet is often prescribed to manage them in clinical practice.
What Are Dosages of Butalbital/Acetaminophen/Caffeine?
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
When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
What does each ingredient do?
Fioricet contains three compounds. Each has a different action to help manage pain:
- Butalbital: This compound is a type of barbiturate. It reduces anxiety and causes drowsiness by relaxing your muscles and nervous system. As it can be habit-forming, medications with butalbital are tightly regulated.
- Acetaminophen: This is a widely used medication to reduce pain and fevers. It’s the generic form of Tylenol.
- Caffeine: Caffeine causes the other two ingredients to work better. It also has some anti-inflammatory effects.
Some Fioricet medications contain additional active ingredients. For example, Fioricet is also available with codeine, an opioid pain reliever.
Mechanism of Action of Fioricet
- Butalbital: Provides muscle relaxation and sedation by enhancing GABA (gamma-aminobutyric acid) activity in the brain, reducing excitability.
- Acetaminophen: Blocks pain signals by inhibiting cyclooxygenase (COX) enzymes in the central nervous system.
- Caffeine: Narrows blood vessels in the brain, counteracting vasodilation that contributes to headache pain.
Off-Label Uses
- Cluster Headaches
- Post-dural Puncture Headache
- Menstrual Migraine Relief
Is Fioricet a controlled substance?
As of August 2022, Fioricet is on the Drug Enforcement Agency (DEA)’s list of exempted prescription drugs. That means it’s not federally regulated even though it contains butalbital, a regulated substance. Some states still choose to classify BAC as a controlled substance.
In April 2022, the DEA proposed removing the exemption. No decision has been made yet.
What should I tell my care team before I take this medication?
They need to know if you have any of these conditions:
- Heart or circulation problems
- If you often drink alcohol
- Kidney disease or problems going to the bathroom
- Liver disease
- Lung disease, asthma, or breathing problems
- Porphyria
- Substance abuse or addiction
- An unusual or allergic reaction to acetaminophen, butalbital or other barbiturates, caffeine, other medications, foods, dyes, or preservatives
- Pregnant or trying to get pregnant
- Breast-feeding
Butalbital APAP Caffeine Interactions
Using this medicine with any of the following medicines is not recommended.
Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Isocarboxazid
- Linezolid
- Mavorixafor
- Methylene Blue
- Moclobemide
- Naltrexone
- Ozanimod
- Phenelzine
- Procarbazine
- Rasagiline
- Riociguat
- Safinamide
- Samidorphan
- Selegiline
- Tranylcypromine
- Viloxazine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acepromazine
- Aclidinium
- Adagrasib
- Alfentanil
- Almotriptan
- Alosetron
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anileridine
- Anisindione
- Apalutamide
- Aprepitant
- Aprobarbital
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Asenapine
- Atazanavir
- Atropine
- Avacopan
- Baclofen
- Belladonna
- Belzutifan
- Bemetizide
- Bendroflumethiazide
- Benperidol
- Bentazepam
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acenocoumarol
- Fosphenytoin
- Lixisenatide
- Ospemifene
- Phenytoin
- Prednisone
- St John’s Wort
- Warfarin
- Zidovudine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Grapefruit Juice
- Tobacco
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Cabbage
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison’s disease (an adrenal problem) or
- Alcohol or drug abuse or dependence, or history of or
- Brain problems (eg, tumor, increased intracranial pressure) or
- Breathing or lung problems (eg, COPD, hypercapnia, hypoxia, sleep apnea) or
- Cor pulmonale (serious heart condition) or
- Depression, or history of or
- Enlarged prostate or
- Head injury, history of or
- Hypothyroidism (underactive thyroid) or
- Obesity (overweight) or
- Trouble urinating or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Diabetes or
- Gallbladder problems or
- Hypotension (low blood pressure) or
- Pancreatitis (swelling of the pancreas) or
- Seizures, or history of—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Lung or breathing problems (eg, asthma, respiratory depression), severe or
- Porphyria (enzyme problem) or
- Stomach or bowel blockage (including paralytic ileus) or
- Surgery (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with these conditions.
Can butalbital-acetaminophen-caffeine treat migraine?
Fioricet is FDA-approved to treat tension headaches. The FDA has not approved its use to treat migraine, but some doctors prescribe it for that purpose.
When doctors prescribe a drug for something other than its approved use, it’s called off-label use.
Some people do find it works for migraine. Still, there’s not a lot of evidence to support its use.
A 2015 review by the American Headache Society analyzed 15 years of research into different migraine treatments. The study grouped treatments into three levels, based on the amount of evidence to support each treatment’s use. Medications that contained butalbital, like Fioricet, were at the lowest level.
The study concluded that there was not enough clinical evidence to support the use of drugs like BAC to treat migraine. The authors recommended that doctors choose first from the wealth of options with stronger evidence.
The American Academy of Neurology suggests that medications like Fioricet be used only as a last resort. Most research suggests that, for most people, the risks outweigh the benefits.
How to Manage Fioricet Interactions ?
Managing Fioricet interactions is crucial to avoid potential side effects or adverse reactions. Fioricet, a combination of butalbital (a barbiturate), acetaminophen, and caffeine, can interact with various medications, supplements, and substances. Here are some strategies for managing these interactions:
1. Be Aware of Central Nervous System (CNS) Depressants
- Examples: Alcohol, benzodiazepines (e.g., diazepam, alprazolam), opioids (e.g., morphine, hydrocodone), muscle relaxants (e.g., cyclobenzaprine), antihistamines (e.g., diphenhydramine).
- Interaction: Combining Fioricet with other CNS depressants can lead to excessive drowsiness, dizziness, respiratory depression, confusion, and increased risk of overdose.
- Management: Avoid using alcohol and consult your doctor before taking any other sedative medications. If combining with another CNS depressant, the healthcare provider may adjust dosages or provide close monitoring.
2. Acetaminophen-Containing Medications
- Examples: Tylenol, certain cold and flu medications, combination pain relievers.
- Interaction: Fioricet contains acetaminophen, and taking additional acetaminophen can increase the risk of liver damage or overdose.
- Management: Keep track of your total daily acetaminophen intake. Do not exceed the recommended daily limit (4,000 mg for adults). Inform your doctor of all medications to avoid unintentional overdose.
3. Avoid or Limit Caffeine Consumption
- Examples: Coffee, tea, energy drinks, certain over-the-counter pain medications.
- Interaction: Fioricet contains caffeine, and adding more caffeine from other sources can increase nervousness, irritability, sleep disturbances, and rapid heart rate.
- Management: Limit other sources of caffeine while taking Fioricet to avoid overstimulation or increased side effects.
4. Anticoagulants and Blood Thinners
- Examples: Warfarin, aspirin, clopidogrel.
- Interaction: Fioricet may interact with anticoagulants, affecting blood clotting and increasing the risk of bleeding.
- Management: If you’re taking a blood thinner, your doctor may monitor your blood clotting levels (e.g., INR) and adjust dosages as needed. Report any unusual bruising or bleeding.
5. Antidepressants and Anxiety Medications
- Examples: SSRIs (e.g., sertraline, fluoxetine), SNRIs (e.g., venlafaxine), tricyclic antidepressants (e.g., amitriptyline), benzodiazepines.
- Interaction: Combining Fioricet with certain antidepressants can increase sedation, drowsiness, and the risk of serotonin syndrome.
- Management: Discuss all medications with your doctor to assess the risks and benefits. They may recommend adjustments or monitor for signs of excessive sedation.
6. Anti-Seizure Medications
- Examples: Phenytoin, carbamazepine, valproate.
- Interaction: Barbiturates like butalbital can increase the metabolism of anti-seizure medications, reducing their effectiveness, or leading to increased side effects.
- Management: Your healthcare provider may need to adjust the dosages of anti-seizure medications if taken with Fioricet. Regular blood tests may be necessary to monitor drug levels.
7. Oral Contraceptives
- Examples: Birth control pills.
- Interaction: Barbiturates in Fioricet can decrease the effectiveness of oral contraceptives, potentially leading to unintended pregnancies.
- Management: Consider using additional contraceptive methods (e.g., condoms) or discuss alternative birth control options with your doctor.
8. Medications That Affect the Liver
- Examples: Statins (e.g., simvastatin), antifungals (e.g., ketoconazole), certain antibiotics (e.g., rifampin), seizure medications.
- Interaction: Fioricet can strain the liver due to its acetaminophen content, especially if combined with other medications metabolized by the liver, increasing the risk of liver damage.
- Management: Inform your doctor about all liver-impacting medications. Avoid heavy alcohol use, and have regular liver function tests if using long-term or in combination with other medications.
9. Medications for Blood Pressure and Heart Conditions
- Examples: Beta-blockers (e.g., propranolol), calcium channel blockers (e.g., verapamil), ACE inhibitors (e.g., lisinopril).
- Interaction: Fioricet’s barbiturate component can lead to low blood pressure or slow heart rate when combined with certain blood pressure medications.
- Management: Monitor blood pressure regularly if taking Fioricet with heart medications. Report any dizziness, lightheadedness, or fainting to your healthcare provider.
10. Certain Antibiotics and Antifungals
- Examples: Erythromycin, clarithromycin, itraconazole, fluconazole.
- Interaction: Some antibiotics and antifungals can inhibit or enhance the metabolism of butalbital, leading to either increased side effects or reduced effectiveness.
- Management: Discuss any new antibiotic or antifungal prescriptions with your doctor if you’re on Fioricet. Dosage adjustments may be necessary.
How to Manage Fioricet Interactions Effectively
- Inform Your Healthcare Provider: Always inform your doctor or pharmacist about all the medications, over-the-counter drugs, supplements, and herbal remedies you are taking.
- Avoid Sudden Changes: Do not stop or change the dosage of Fioricet or any interacting medication without consulting your healthcare provider. Sudden changes can lead to withdrawal symptoms or adverse effects.
- Regular Monitoring: If you’re on long-term Fioricet therapy, consider regular monitoring of liver function, kidney function, and blood work to check for any potential interactions or organ impact.
- Read Labels Carefully: Check over-the-counter medication labels for acetaminophen, caffeine, or any ingredients that may interact with Fioricet.
- Use a Single Pharmacy: Whenever possible, use the same pharmacy for all prescriptions. This allows the pharmacist to identify potential drug interactions more easily.
- Keep a Medication List: Maintain an up-to-date list of all medications, dosages, and frequency. Share it with every healthcare provider you visit.
- Monitor for Side Effects: Be vigilant for any unusual symptoms, such as extreme drowsiness, confusion, jaundice, unusual bleeding, or breathing difficulties, and report them promptly.
- Take as Directed: Follow the prescription exactly. Do not exceed the recommended dosage or frequency.
By staying informed and proactive, you can effectively manage potential interactions with Fioricet and reduce the risk of adverse effects.
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Can I take butalbital-acetaminophen-caffeine while pregnant?
There is not enough research to know if BAC is safe during pregnancy. For this reason, experts recommend that you avoid BAC during pregnancy.
According to 2021 research, barbiturates like butalbital pose several risks to pregnant people. It may suppress your immune system. There’s also a higher risk of developmental issues for the fetus.
Experts generally consider acetaminophen safe during pregnancy. Still, they recommend low doses. Recent research suggests that it could affect development in the womb.
Research suggests that up to 200 mg per day of caffeine is safe during pregnancy.
If you’re pregnant or may become pregnant, talk with your doctor about other options.
Fioricet Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Lightheadedness
- shortness of breath
Incidence not known
- Abdominal or stomach pain
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- blurred vision
- change in the frequency of urination or amount of urine
- chills
- cough
- diarrhea
- difficulty with breathing
- difficulty with swallowing
- dizziness
- drowsiness
- dry mouth
- fainting
- fast, pounding, or irregular heartbeat or pulse
- flushed or dry skin
- fruit-like breath odor
- hives, itching, or skin rash
- increased hunger
- increased thirst
- increased urination
- joint or muscle pain
- loss of appetite
- nausea or vomiting
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- seizures
- shakiness in the legs, arms, hands, or feet
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- sweating
- swelling of the feet or lower legs
- tightness in the chest
- trembling or shaking of the hands or feet
- troubled breathing
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Confusion as to time, place, or person
- dark urine
- difficult or painful urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever
- general feeling of discomfort or illness
- hallucinations
- headache
- holding false beliefs that cannot be changed by fact
- increased sweating
- irregular, fast or slow, or shallow breathing
- light-colored stools
- loss of appetite
- pale or blue lips, fingernails, or skin
- restlessness
- sudden decrease in the amount of urine
- sweating
- trouble sleeping
- unpleasant breath odor
- unusual excitement, nervousness, or restlessness
- vomiting of blood
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Relaxed and calm
- sleepiness
Incidence not known
- Anxiety
- bloated
- constipation
- continuing ringing or buzzing or other unexplained noise in the ears
- depression
- earache
- excess air or gas in the stomach or intestines
- false or unusual sense of well-being
- full feeling
- hearing loss
- heartburn
- heavy eyelids
- high energy
- hot spells
- hyperventilation
- irritability
- numbness
- pain in the leg
- passing gas
- sluggishness
- stuffy nose
- tingling sensation
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.