Fioricet Pregnancy and Breastfeeding Warnings

Acetaminophen / butalbital / caffeine is also known as: Alagesic LQ, Anolor 300, Anoquan, Arcet, Dolmar, Esgic, Esgic-Plus, Ezol, Femcet, Fioricet, Fiorpap, Geone, Isocet, Margesic, Orbivan, Pharmagesic, Phrenilin Forte, Repan, Tenake, Tencet, Triad, Two-Dyne, Vanatol LQ, Vtol LQ, Zebutal

Acetaminophen / butalbital / caffeine Pregnancy Warnings

Use is not recommended unless clearly needed

US FDA pregnancy category: C

Comment: Monitor for barbiturate withdrawal in neonates

Animal reproduction studies have not been conducted on this combination product. Epidemiologic data for acetaminophen, including a population based case-control study from the National Birth Defects Prevention Study (n= 11,610) and data from 26,424 live singleton births have shown no increased risk of major birth defects in children with first trimester prenatal exposure. In 2015, the US Food and Drug Administration released results of their evaluation on published research studies looking at mothers who took acetaminophen (either over the counter or as a prescription product) at any time during their pregnancy and the risk of attention deficit hyperactivity (ADHD) in their babies. They found all studies reviewed had potential limitations in their designs that prevented drawing reliable conclusions. Barbiturates have been reported to readily cross the placental barrier. A 2-day old infant whose mother had taken a butalbital-containing product during the last two months of pregnancy experienced withdrawal seizures; butalbital was found in the infant’s serum. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Acetaminophen / butalbital / caffeine Breastfeeding Warnings

Acetaminophen, butalbital, and caffeine are excreted into human milk in small concentrations. The significance of the effects on nursing infants has not been reported, but due to the potential for serious adverse reactions in nursing infants, other agents may be preferred.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes (acetaminophen); Yes (barbiturates); Yes (caffeine)

May 17, 2023

Pharmacist Tips for Fioricet

Fioricet is a combination medication containing butalbital, acetaminophen, and caffeine. It’s taken by mouth as needed, typically every 4 hours, to treat tension headaches.

But it’s not a first-choice option because it can become habit-forming and can worsen headaches if taken too frequently. In addition, Fioricet can cause side effects, such as sleepiness and dizziness. It’s available as pills and an oral syrup.

Fioricet can make you sleepy, dizzy, and lightheaded. Don’t drive or use any heavy machinery until you know how the medication affects you.

Avoid alcohol while taking Fioricet because it can make you more drowsy and dizzy, raise your risk of accidental injuries and liver damage, and worsen headaches

Take Fioricet exactly as your provider instructed you to. Don’t change your dose or stop taking Fioricet without talking to your provider first. To stop the medication, they might need to lower your dose slowly before stopping it completely. This lowers your risk of getting withdrawal symptoms, such as seizures, hallucinations, and worsening of headaches.

Make sure to tell your provider about all of the medications you’re taking before starting Fioricet. Don’t start any new medications while taking Fioricet without talking to your provider first to make sure the combination is safe to take.

Many over-the-counter and prescription medications contain acetaminophen. Don’t use other medications containing acetaminophen unless your provider specifically said it was okay for you to do so. Ask your provider or pharmacist if you aren’t sure if a certain medication contains acetaminophen.

Store Fioricet at room temperature in a place out of reach from children due to the life-threatening risk of accidental overdose and misuse. If you don’t need to take Fioricet anymore, choose a medication take-back option to get rid of it safely.

If you or someone you know accidentally overdoses on Fioricet, get emergency medical help or call your local poison control center at 1-800-222-1222 right away.

For the liquid form: Make sure to only use a medication dose cup or oral syringe from the pharmacy to measure out your dose. Don’t use household spoons because they aren’t accurate and might cause you to take the wrong dose.

May 16, 2023

Is Fioricet a Controlled Substance?

Fioricet is a controlled substance in some states. Because it contains butalbital, a medication that can be misused and cause dependence, some state governments place strict regulations on Fioricet. But it’s not classified as a controlled substance in all states because it contains acetaminophen. Initially, regulators believed that the acetaminophen in Fioricet discourages people from misusing Fioricet. This is because taking too much acetaminophen can cause harm, such as liver damage.

Fioricet on its own is not a federally controlled substance. Although it contains butalbital, it’s on the Drug Enforcement Agency (DEA)’s list of exempted prescription products. But some states do classify BAC as a controlled substance.

Other combinations that contain Fioricet or are similar to Fioricet may be controlled substances. The DEA classifies Fiorinal, which contains butalbital, aspirin, and caffeine, as a Schedule III drug. That means that there’s a low to moderate risk of dependence or overuse.

BAC Fioricet

In April 2022, the DEA proposed removing the exemption for Fioricet. The proposed rule change would add all products that contain butalbital to its list of Schedule III controlled substances.

So regulators left it up to the states to decide on how to classify Fioricet. But recent data shows that the acetaminophen in Fioricet might not be enough to stop people from misusing this medication. There’s a possibility that the classification of Fioricet might change in the future. Fioricet is a controlled substance in some states. Because it contains butalbital, a medication that can be misused and cause dependence, some state governments place strict regulations on Fioricet.

But it’s not classified as a controlled substance in all states because it contains acetaminophen. Initially, regulators believed that the acetaminophen in Fioricet discourages people from misusing Fioricet. This is because taking too much acetaminophen can cause harm, such as liver damage. So regulators left it up to the states to decide on how to classify Fioricet. But recent data shows that the acetaminophen in Fioricet might not be enough to stop people from misusing this medication.

There’s a possibility that the classification of Fioricet might change in the future.

May 16, 2023

How to Treat Fioricet overdose

The treatment of Fioricet overdose is complicated by the presence of two substances which are highly toxic when taken in excessive amounts. Fioricet overdoses generally result in toxic amounts of both acetaminophen and butalbital being consumed at once, requiring both overdoses to be treated at once.

Fioricet overdose by anyone and/or any consumption by persons to whom it is not prescribed (particularly children) is always a medical emergency and medical attention must be sought immediately if an overdose or consumption by other persons is suspected.

Fioricet overdose is often fatal and symptoms may not present for hours following consumption, once initial overdose symptoms present they can progress rapidly and there may not be time to reach appropriate medical care after this point.

Acetaminophen over-exerts its toxicity through the production of a toxic metabolite which produces liver damage in doses of 3,000mg or more per day and acute liver failure in doses above that. The specific antidote to acetaminophen overdose is N-acetyl-cysteine. Kidney failure and stomach bleeding may also occur.

Butalbital overdoses exerts its toxicity through excessive sedation resulting in respiratory depression and ultimately death via hypoxia. Nonlethal overdoses may also result in coma and death. There is no specific antidote to butalbital overdose and treatment is supportive, common treatment regimens generally include the administration of intravenous administration of saline, naloxone, thiamine, glucose, NaHCO3 to alkalize the urine to increase rate of excretion, and activated charcoal via nasogastric tube. It is not uncommon for doctor to recommend observation of the patient in the Emergency Department for a number of hours or admission to the hospital for several days of observation if symptoms are severe and to counsel the patient on drug abuse and/or refer them for psychiatric evaluation.

Recommended dosages for this drug are based on someone’s age and weight and also the scheduled frequency of taking it.

Acetaminophen overdoses happen when someone:

Takes too much of the pain medication at one time
Re-doses too soon
Takes multiple medications at the same time that also contain acetaminophen

For a healthy adult weighing at least 150 pounds, the maximum daily dose of acetaminophen is 4,000 milligrams (mg). However, you can experience liver damage even if you stay at or below 4,000mg if you take this maximum dose for an extended period.

As such, doctors often recommend a maximum daily dose closer to 3,000 mg. Read the drug label carefully and know exactly how much acetaminophen is in each tablet, capsule or liquid dose.

The following table further details acetaminophen dosage recommendations:

	325mg	500mg	650mg (extended-release)
Take how many pills at a time?	1 or 2	1 or 2	1 or 2
Take how often?	Every 4 to 6 hours	Every 4 to 6 hours	Every 8 hours
Safest maximum daily dose for most adults	8 pills	6 pills	4 pills
Never take more than this in a 24-hour period	12 pills (3,900mg)	8 pills (4000mg)	6 pills (3,900mg)

For children, acetaminophen doses usually come in 80mg and 160mg, although many of the medications are delivered in liquids (syrups), not pills or chewable tablets.

Body weight plays more of a factor in dosing for kids than it does for adults. The smaller and younger a child is the more careful adults must be when giving the correct dosage. Get an updated weight on your child before administering acetaminophen or any medications that have acetaminophen in them.

Here are basic guidelines for children taking acetaminophen:

Child’s Weight	Syrup/Liquid (160mg)	Pills (80mg)
24 to 35 lbs	1 tsp	2 tablets
26 to 47 lbs	1.5 tsp	3 tablets
48 to 59 lbs	2 tsp	4 tablets
60 to 71 lbs	2.5 tsp	5 tablets
72 to 95 lbs	3 tsp	6 tablets
96 or more lbs	4 tsp	8 tablets

An important note: Children under the age of 6 should not take more than one medication at a time that has acetaminophen as an active ingredient.

If your child is younger than 2 years old, check with your pediatrician, an urgent-care physician or pharmacist before giving any medication that contains acetaminophen.

For adults and children, if the recommended dosages don’t relieve symptoms, consult with a doctor before making the decision to increase any dosages. Acetaminophen toxicity can lead to life-threatening acute liver failure.

How Often Can You Take Acetaminophen?

Dosing frequency is a crucial part of how much acetaminophen you can take at one time or during a one-day period. How long it takes acetaminophen to work, duration of its effects, and how long the medication stays in your body determine how often you should re-dose.

The recommended frequency is every four to six hours. After ingestion, it takes acetaminophen between 30 and 90 minutes to start working. Several factors, including formulation, other drug and alcohol intake influence the effects of acetaminophen.

If you have questions about acetaminophen and the right dose for you, speak with your doctor. Discuss other medications you may be taking and your overall health to determine the best plan for your needs.

How Long Does Acetaminophen Work For?

Acetaminophen typically lasts four hours for both pain relief and fever reduction. This is why the recommended dosing frequency is no more than every four to six hours.

The biological half-life of a drug plays an essential role in its effectiveness and safety. It is also an important factor for determining dosage recommendations.

How Long Does Acetaminophen Stay in Your System?

Scientists gauge the time it takes for your body to eliminate acetaminophen from the system by using the medication’s estimated half-life. A drug’s half-life is the time it takes for half a dose to be metabolized and eliminated from your bloodstream. Acetaminophen half-life elimination for therapeutic doses is between one and two-and-a-half (2.5) hours.

However, the expected half-life of acetaminophen can vary from person to person. Factors that affect its half-life include age, genetics, weight and overall health. Generally, a therapeutic dose of acetaminophen flushes fully from your system within 24 hours.

An acetaminophen overdose can extend the half-life of the drug to four and eight, meaning it may take up to three times longer for you to get the drug out of your body. If you re-dose too soon following even a small overdose period, it can lead to an acute case of severe acetaminophen toxicity.

Is Fioricet Addictive?

Although it’s only a prescription headache medication, Fioricet has the potential to cause addiction. If a person follows their prescription guidelines and uses the medication correctly, the risks of addiction are low. However, if someone takes too much Fioricet, they may develop tolerance to its effects. A person with tolerance to a certain dose of Fioricet will require higher doses of the medication to alleviate their headaches.

When a person with tolerance starts to take more Fioricet, possibly by obtaining more prescriptions, they may eventually become dependent on it. In other words, they may feel unable to get through the day without taking Fioricet; if they stop, they will experience symptoms of withdrawal. These symptoms arise because their body has grown accustomed to Fioricet in high doses.

If a Fioricet-dependent person attempts to weather withdrawal alone, it’s likely they will take Fioricet again just to relieve the symptoms of withdrawal. This is a hallmark characteristic of addiction. Anyone who compulsively abuses Fioricet to avoid withdrawal likely has an addiction to Fioricet. Additionally, people with an addiction to Fioricet will experience cravings for the medication which further compel them to keeping using it.

Moreover, the ingredient Butalbital is an addictive substance in its own right. Butalbital can cause someone to get “high” because it’s a Central Nervous System (CNS) Depressant. Since Butalbital is part of Fioricet, it is possible for someone to abuse Fioricet as a recreational drug. At high doses, Fioricet can intoxicate a person in a manner similar to alcohol. People who abuse Fioricet for this purpose have as much of a risk of developing an addiction as they would have if they repeatedly used an illegal drug.

How Much Acetaminophen Is Too Much?

Aside from determining how long acetaminophen works and how long it stays in your system, the drug’s half-life also determines how much is too much to take. The goal of medication is to achieve a steady state, at which point the amount of the drug you ingest and the amount that’s eliminated are equal.

Regardless of a drug’s half-life, it takes approximately four times longer for its concentration to reach a steady state in your body. Acetaminophen side effects often occur when you’re not in a steady state. A small amount of acetaminophen is metabolized into the compound NAPQI, which can cause liver toxicity in large amounts.

Taking too much acetaminophen can cause acute liver damage, which can be fatal. As such, you should not exceed the 4,000 mg maximum daily dose recommendation (you should ideally stay closer to 3,000 mg). Acetaminophen may also effect blood pressure. One 2022 clinical research study found that regular daily intake of 4 g acetaminophen increased systolic blood pressure in individuals with hypertension by about 5 mm Hg compared with a placebo.

Primary symptoms of acetaminophen overdose are:

Abdominal pain
Nausea
Vomiting
Diarrhea
Excessive sweating
Jaundice
Irritability
Seizures
Coma

In case you suspect someone took an overdose of acetaminophen or if you see someone exhibit the above symptoms, you should immediately call 911, emergency medical services, a poison control center or a doctor.

Emergency room treatment will depend on the presenting condition and other drugs that may have been taken. If you make it to the hospital just after taking an overdose, the doctor will attempt to empty your stomach.

Doctors like to prescribe a dose of activated charcoal within four hours of an overdose to bind drugs remaining in your gastro-intestinal tract. They also give N-Acetylcysteine, an antidote for acetaminophen toxicity, orally or intravenously within eight hours.

Emergency doctors recommend that anyone suspected to have taken an acetaminophen overdose get treatment as soon as possible, even before the symptoms occur. Early treatment of acetaminophen overdose can improve the outcome significantly.

May 15, 2023

Acetaminophen Mechanism of Action

Acetaminophen is a pain reliever and fever reducer. Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Acetaminophen, butalbital, and caffeine is a combination medicine used to treat tension headaches that are caused by muscle contractions.

Paracetamol (acetaminophen) is generally considered to be a weak inhibitor of the synthesis of prostaglandins (PGs). However, the in vivo effects of paracetamol are similar to those of the selective cyclooxygenase-2 (COX-2) inhibitors. Paracetamol also decreases PG concentrations in vivo, but, unlike the selective COX-2 inhibitors, paracetamol does not suppress the inflammation of rheumatoid arthritis.

It does, however, decrease swelling after oral surgery in humans and suppresses inflammation in rats and mice. Paracetamol is a weak inhibitor of PG synthesis of COX-1 and COX-2 in broken cell systems, but, by contrast, therapeutic concentrations of paracetamol inhibit PG synthesis in intact cells in vitro when the levels of the substrate arachidonic acid are low (less than about 5 mumol/L).

When the levels of arachidonic acid are low, PGs are synthesized largely by COX-2 in cells that contain both COX-1 and COX-2. Thus, the apparent selectivity of paracetamol may be due to inhibition of COX-2-dependent pathways that are proceeding at low rates.

This hypothesis is consistent with the similar pharmacological effects of paracetamol and the selective COX-2 inhibitors. COX-3, a splice variant of COX-1, has been suggested to be the site of action of paracetamol, but genomic and kinetic analysis indicates that this selective interaction is unlikely to be clinically relevant.

There is considerable evidence that the analgesic effect of paracetamol is central and is due to activation of descending serotonergic pathways, but its primary site of action may still be inhibition of PG synthesis.

The action of paracetamol at a molecular level is unclear but could be related to the production of reactive metabolites by the peroxidase function of COX-2, which could deplete glutathione, a cofactor of enzymes such as PGE synthase.

Currently, products that contain butalbital/aspirin/caffeine are classified as schedule III controlled substances; butalbital products listed on the DEA’s list of Exempted Prescription Products, including butalbital/acetaminophen/caffeine products, are unscheduled. This rule change eliminates the disparity of scheduling for butalbital-containing products and recognizes all products containing butalbital, including Fioricet, as schedule III controlled substances under the Iowa uniform Controlled Substances Act.

May 15, 2023

Important Acetaminophen Warning from FDA

Fioricet capsules contain a combination of acetaminophen, butalbital, and caffeine. Acetaminophen is a pain reliever and fever reducer. Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Taking too much acetaminophen can cause liver damage, sometimes serious enough to require liver transplantation or cause death. You might accidentally take too much acetaminophen if you do not follow the directions on the prescription or package label carefully, or if you take more than one product that contains acetaminophen.

To be sure that you take acetaminophen safely, you should

not take more than one product that contains acetaminophen at a time. Read the labels of all the prescription and nonprescription medications you are taking to see if they contain acetaminophen. Be aware that abbreviations such as APAP, AC, Acetaminophen, Acetaminoph, Acetaminop, Acetamin, or Acetam. may be written on the label in place of the word acetaminophen. Ask your doctor or pharmacist if you don’t know if a medication that you are taking contains acetaminophen.
take acetaminophen exactly as directed on the prescription or package label. Do not take more acetaminophen or take it more often than directed, even if you still have fever or pain. Ask your doctor or pharmacist if you do not know how much medication to take or how often to take your medication. Call your doctor if you still have pain or fever after taking your medication as directed.
be aware that you should not take more than 4000 mg of acetaminophen per day. If you need to take more than one product that contains acetaminophen, it may be difficult for you to calculate the total amount of acetaminophen you are taking. Ask your doctor or pharmacist to help you.
tell your doctor if you have or have ever had liver disease.
not take acetaminophen if you drink three or more alcoholic drinks every day. Talk to your doctor about the safe use of alcohol while you are taking acetaminophen.
stop taking your medication and call your doctor right away if you think you have taken too much acetaminophen, even if you feel well.

Talk to your pharmacist or doctor if you have questions about the safe use of acetaminophen or acetaminophen-containing products.

Are there alternatives to butalbital-acetaminophen-caffeine?

If you’re not able to take BAC, a healthcare professional may suggest one or more of the following interventions:

lifestyle changes, including staying hydrated, getting adequate sleep, and reducing stress
over-the-counter medications such as aspirin, acetaminophen, or ibuprofen, with or without caffeine
other prescription medications, depending on the underlying cause of your headache, such as:
- ketorolac
- naproxen
- antidepressants
- beta-blockers

May 15, 2023

Fioricet Dosing Information and Fioricet Overdose Treatment

Usual Adult Dose of Fioricet for Headache:

Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

Acetaminophen 325 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 tablet(s), capsule(s), or tablespoonful(s) orally every 4 hours.
Maximum daily dose: 6 doses

Acetaminophen 500 mg, butalbital 50 mg, and caffeine 40 mg:
1 tablet or capsule orally every 4 hours.
Maximum daily dose: 6 doses

Acetaminophen 750 mg, butalbital 50 mg, and caffeine 40 mg:
1 tablet orally every 4 hours.
Maximum daily dose: 5 tablets

Usual Pediatric Dose of Fioricet for Headache:

12 years and older:
Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

Fioricet Overdose Treatment

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.

What Are The Symptoms Of A Fioricet Overdose?

While Butalbital is the addictive ingredient in Fioricet, Acetaminophen is the ingredient which is liable to cause an overdose. Unfortunately, people who misuse Fioricet as a recreational drug or as a way to suppress withdrawal are most likely to suffer an overdose.

When a person overdoses on Fioricet, the Acetaminophen will damage their liver. In severe cases, an overdose can even provoke fatal liver failure. For this reason, it is dangerous to take Fioricet together with another medication which contains Acetaminophen because it increases the risk of overdose and death. Furthermore, drinking alcohol while taking Fioricet may also inflict liver damage.

A Fioricet overdose is a medical emergency, so it’s important to know the symptoms. An overdose on Fioricet may cause jaundice, a yellowing of the skin and eyes. Other symptoms of an overdose include:

Confusion
Convulsions and seizures
Fainting
Irregular heartbeat
Lack of appetite
Nausea and vomiting
Restlessness
Stomach pain
Sweating
Tremors

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Fioricet can be fatal.

Overdose symptoms may also include insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.

A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation.

Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading.

To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

May 12, 2023

What are the Risks and Warnings for Fioricet?

Fioricet can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options

Liver damage

Risk factors: Drinking alcohol | Taking other medications containing acetaminophen | Taking too much Fioricet | History of liver problems

Taking too much acetaminophen can cause liver damage that can be permanent and life-threatening. For adults, the maximum amount of acetaminophen is 3 or 4 grams in a 24-hour period, depending on your provider’s instructions.

Speak to your provider before using Fioricet if you have liver problems since it can cause further damage to your liver. Also, avoid drinking alcohol while taking Fioricet because this combination can harm your liver too.

Signs of liver problems include dark urine, feeling tired, upset stomach or stomach pain, or yellowing of the skin or whites of the eyes. If you notice any of these symptoms, call your provider right away.

Difficulty concentrating and extreme sleepiness

Risk factors: Taking high doses of Fioricet | Age 65 years or older | Drinking alcohol | Taking other medications that can cause sleepiness

Fioricet can cause extreme sleepiness and lower your ability to think, react, and focus. Don’t drink alcohol or take other medications that can cause sleepiness or “brain fog”, such as pain medications or antidepressants, with Fioricet. Doing so can worsen these side effects. Make sure you know how this medication affects you before driving a car or doing activities that require your concentration. Talk to your healthcare provider right away if you feel too sleepy from taking Fioricet.

Serious skin or allergic reactions

Risk factors: History of serious skin reactions | Allergy to acetaminophen (Tylenol)

Fioricet contains acetaminophen (Tylenol), which can rarely cause life-threatening skin reactions and allergic reactions. If you’re allergic to acetaminophen, don’t take Fioricet. If you develop symptoms of an allergic reaction, such as swelling of the face, mouth, or throat, trouble breathing, itchy red rash (hives), or vomiting, stop taking Fioricet and call for emergency medical help right away. If you develop symptoms of a skin reaction, such as a reddening or peeling of the skin, painful rash, or fluid-filled blisters, stop taking Fioricet and go to the emergency room right away.

Misuse, dependence, and withdrawal

Risk factors: Taking Fioricet longer than prescribed | Taking higher doses of Fioricet than prescribed | Taking Fioricet more often than prescribed

Fioricet contains butalbital, which can be habit-forming. Misuse of Fioricet can lead to dependence, accidental overdose, and even death. Doing so can also cause withdrawal symptoms, like seizures, restlessness, trouble sleeping, and shakiness, if you lower your dose or stop taking the medication suddenly. To lower the risk of physical dependence, don’t take Fioricet longer than prescribed, at higher doses than prescribed, or more often than prescribed.

Call for emergency medical help if you have any symptoms of taking too much butalbital, including sleepiness, trouble breathing, dizziness, confusion, or loss of consciousness. If you no longer want to take Fioricet, talk to your healthcare provider so they can instruct you on how to stop taking the medication safely. Speak to your healthcare provider about alternative treatments if you have concerns about taking Fioricet.

May 12, 2023

Can I Take Other Pain Medications While I’m Taking Fioricet for Pain?

You might be able to take other pain medications, like ibuprofen (Advil, Motrin) or naproxen (Aleve), with Fioricet if you need more relief for your headache. These medications work differently to ease pain and they can help lower the amount of Fioricet you need to relieve your symptoms.

Taking less Fioricet means you’re not as likely to experience the dangers or side effects of taking this medication. But don’t take other medications containing acetaminophen (Tylenol). Fioricet already contains acetaminophen, and you might accidentally take too much acetaminophen if you take these other medications and Fioricet together.

This can lead to serious liver damage. Before using other pain medications with Fioricet, speak with your healthcare provider to make sure it’s safe for you to do so. Other pain medications still carry risks that shouldn’t be ignored (e.g., heart risks, kidney problems).

What is FIoricet ?

BUTALBITAL; ACETAMINOPHEN; CAFFEINE (byoo TAL bi tal; a set a MEE noe fen; KAF een) 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

What may interact with this medication?

Alcohol or medications that contain alcohol
Antidepressants, especially MAOIs like isocarboxazid, phenelzine, tranylcypromine, and selegiline
Antihistamines
Benzodiazepines
Carbamazepine
Isoniazid
Medications for pain like pentazocine, buprenorphine, butorphanol, nalbuphine, tramadol, and propoxyphene
Muscle relaxants
Naltrexone
Phenobarbital, phenytoin, and fosphenytoin
Phenothiazines like perphenazine, thioridazine, chlorpromazine, mesoridazine, fluphenazine, prochlorperazine, promazine, and trifluoperazine
Voriconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

May 12, 2023

Can I Drink Coffee While Taking Fioricet?

It’s recommended to limit caffeine because Fioricet already contains caffeine. The maximum dose of Fioricet is 6 doses per day, which equates to 240 mg of caffeine. For comparison, an 8-ounce cup of coffee contains 95 mg to 165 mg of caffeine.

According to the FDA, 400 mg of caffeine is considered a safe amount for adults that won’t cause dangerous side effects. Too much caffeine can lead to nervousness, shakiness, restlessness, trouble sleeping, and a fast heart rate. If you experience these symptoms, avoid other sources of caffeine and use the lowest possible amount of Fioricet.

Fioricet

Fioricet is a combination medication composed of acetaminophen (Tylenol’s main ingredient), caffeine, and butalbital. It is used to relieve tension headaches and can also be prescribed to treat mild to moderate migraine.

Butalbital belongs to the barbiturate class of medication, which means it is a sedative, or relaxant.¹ This makes Fioricet a barbiturate. Because it contains acetaminophen and caffeine, it is also a pain reliever and a stimulant.

Medications containing this combination of ingredients come in capsule and tablet forms, which can be taken by mouth. This combination of medications is also available in generics. Other brand names and formulations include:

Esgic®
Fioricet® with Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)
Phrenilin® with Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)²

What are the ingredients in Fioricet?

The active ingredients in Fioricet are acetaminophen, caffeine, and butalbital.

How does Fioricet work?

The acetaminophen in Fioricet is a pain reliever, the caffeine works as a stimulant to increase the acetaminophen’s effectiveness, and the butalbital is a sedative that decreases anxiety while causing relaxation and sleepiness. These actions are believed to ease migraine symptoms, but there is limited evidence that barbituates ease migraine symptoms.

What are the possible side effects of Fioricet?

The most common side effects from Fioricet include:

Drowsiness
Upset stomach
Vomiting
Stomach pain
Depression
Lightheadedness
Confusion³

The following side effects could be signs of allergy or more serious complications and should be reported to health provider immediately:

Skin rash
Itching
Difficulty breathing²

This is not an exhaustive list of all potential side effects of Fioricet.

For more information, consult your doctor or healthcare provider. Patients should talk to their doctor about what to expect with treatment with Fioricet. If you notice any new or worsening side effects, contact your doctor or healthcare provider immediately.

Things to note about Fioricet

Fioricet can be habit-forming, so you should use extreme caution if you decide to take it. Additionally, some people who take barbituates or opioids for extended periods can experience rebound headaches, which can increase in severity. These are also known as MOH, or medication overuse headaches.

Barbituates can cause drowsiness, and their effect can be increased by alcohol use. It is important not to drive or use heavy machinery until you know how this drug affects you.²

Before taking Fioricet, tell your doctor if you:

Are allergic to any ingredients in the medication
Are taking blood thinners, antidepressants, antihistamines, or other sedatives like sleeping pills or tranquilizers.
Are taking pain medications. Many over-the-counter pain relievers contain acetaminophen, and too much of this drug can be harmful.
Have ever had liver disease, porphyria, or depression
Are pregnant, plan to become pregnant, or are breastfeeding²

You should begin no medication or supplement without first checking with your health care provider and should let them know of any other prescriptions, OTCs, and herbals you are taking to ensure there are no interactions.