Fioricet Drug Class: Is Butalbital A Controlled Substance?

Medically Reviewed by Johnelle Smith, M.D on September 2, 2022

Butalbital, the main ingredient in Fioricet, is a controlled substance that falls under Schedule III, which means getting it without a doctor’s recommendation or purchasing it over the counter is not possible. However, Fioricet is exempted from the controlled status.

Is Fioricet A Controlled Substance?

Butalbital (sold under the brand names Fioricet and Esgic) is a prescription medication used to treat migraines, tension headaches, and chronic daily headache pain.

It has also been used in the past to relieve pain after surgery or injury and to help people sleep when they are having trouble sleeping.

The U.S. Food and Drug Administration does classify butalbital products as controlled substances due to their potential for misuse.

However, Fioricet is considered an exempted prescription product, which means it is not as controlled as other butalbital-containing products.

Why Fioricet Is Not Considered A Controlled Substance

Fioricet must be prescribed — you can’t purchase it over the counter. This is how it is federally regulated, rather than being controlled, like other drugs of abuse.

With controlled substances, there is little to no medical use available. Fioricet is not a federally controlled substance under the Controlled Substances Act (CSA).

In 2019, a proposal was made by the Drug Enforcement Administration (DEA) to make Fioricet an exempted prescription product Schedule III drug.

Exempted products on the controlled substances list are those which contain the chemical in the drug class which is considered addictive or a risk for misuse, but also contain other ingredients which are believed to negate the risk for addiction.

With a Fioricet prescription, a person must follow the prescribed dosage guidelines to avoid abuse, physical dependence, and to reduce addiction risk.

Reasons why the government, doctors, pharmacy technicians, and prescribers do not consider Fioricet a controlled substance include the following:

Contains Acetaminophen

The dosages of butalbital, acetaminophen, and caffeine contained in a single tablet of Fioricet are as follows: 50 mg, 325 mg, and 40 mg, respectively.

To prescribe butalbital-containing products, a valid Drug Enforcement Administration (DEA) number is required.

A doctor or healthcare provider must write a Fioricet prescription for a person to obtain the medication, which helps to regulate its use.

The acetaminophen (the main ingredient in Tylenol) in Fioricet is believed to counteract the butalbital that could possibly lead to addiction.

Low Risk For Addiction

Due to the medication’s medical use potential, Fioricet is not considered nearly as addictive as other painkillers, such as OxyContin (oxycodone) or Vicodin (hydrocodone).

However, use of it can still lead to Fioricet dependence in some people.

People who take too much of it can also become dependent on it and experience withdrawal symptoms when they stop taking it.

What Drug Class Is Fioricet?

All butalbital products, including Fioricet, are classified as barbiturates, analgesics, or opioid combos. Barbiturates produce their effects by acting on the central nervous system (CNS).

Fioricet with codeine belongs to a group of medications called analgesics or opioid combinations.

How Fioricet Works In The Body

Fioricet has three active ingredients, butalbital, acetaminophen, and caffeine, that work together to alleviate headaches and pain.

Acetaminophen and barbiturates are analgesics that alleviate pain, while barbiturates are also anti-anxiety agents.

Experts believe that butalbital works by relaxing muscle contractions and enhancing the inhibitory effects of GABA when it is used to treat pain caused by tension headaches.

What States Control Fioricet?

Many states have placed tight regulations on butalbital.

States that control Fioricet include:

  • Georgia
  • West Virginia
  • New Mexico
  • Maryland
  • Utah
  • Rhode Island
  • Illinois

Why Fioricet Is Controlled In Some States And Not Others

As stated by the Drug Enforcement Agency (DEA), Fioricet is not a controlled substance. But because it is a barbiturate, butalbital is considered a controlled substance by the FDA.

In high doses or for long periods of time, these drugs can become addictive and be abused.

According to the Controlled Substances Act (CSA), all barbiturate products are Schedule III controlled substances.

However, Fiorinal, which also contains butalbital, is a controlled substance.

Effects Of Fioricet Abuse

Taking too much butalbital in a short period of time can lead to dangerous side effects.

Some of these side effects are fatal and include respiratory depression, coma, heart failure, overdose, and seizures.

Other butalbital side effects include depression, nervousness, lightheadedness, anxiety, drowsiness, insomnia, and gastrointestinal problems.

People who abuse Fioricet may also experience liver damage, severe withdrawal symptoms, severe skin reactions, and overdose.

Get Help For Substance Use Disorders

If you’re in need of help for substance use disorders, it’s important to seek immediate help from healthcare professionals or addiction treatment centers.

Contact today to locate a drug rehabilitation center near you.

This page does not provide medical advice. See more

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Medically Reviewed by
Johnelle Smith, M.D on September 2, 2022
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