Understanding the side effects associated with Fioricet

Fioricet (Butalbital APAP Caffeine ) are helpful to treat many pain ailments, but they come with a plenty of side effects too.

If not used as prescribed by the doctor can lead to harmful and serious side effects too. Some of the side effects are mild and they vanish with time as your body gets used to the medicine, but some serious side effects like overdose of these drugs can be fatal too. Fioricet is also among the narcotic drugs having mild to serious side effects.

Let us understand about the possible side effects of Fioricet depending upon their severity.

Frequently observed side effects

Some of the adverse reactions of Fioricet observed frequently are

  • Nausea
  • Breathlessness
  • Dizziness
  • Sedation
  • Vomiting
  • Abdominal pain
  • Lightheadedness
  • Intoxicated feeling

Infrequent observed side effects

Listed below are some infrequently observed side effects of Fioricet

Central nervous system

  • Shaky feeling,
  • headache,
  • heavy eyelids,
  • fainting,
  • agitation,
  • hot spells,
  • seizure,
  • fatigue, high energy,
  • Sluggishness and numbness.

Excitement and mental confusion can occur due to sensitivity, especially in debilitated or elder patients or because of over dosage of butalbital.

Nervous system (Autonomic)

Dry mouth and hyperhidrosis


Heartburn, constipation, flatulence and difficulty in swallowing are some gastrointestinal related side effects seen in patients.


Muscle fatigue and leg pain




Fever, nasal congestion, tinnitus, pruritus, euphoria and other allergic reactions

There are some rare side effects associated with consumption of Fioricet, which are not known to patients. Let us know about them.

  • Decreased blood platelets
  • Decreased white blood cells
  • Liver failure (acute)
  • Extra heartbeat
  • Giant hives
  • Memory loss
  • Rickets
  • Trouble in breathing
  • Wheezing
  • Feeling restless
  • Fast heartbeat
  • Rash
  • Skin redness
  • Swelling in vocal cords
  • Skin inflammation
  • Hallucination
  • Throat tightness

The side effects can be mild to severe, but you should consult your doctor if any symptoms persist, so that you can treat the side effects. Many people using Fioricet do not have any severe side effects. It depends from person to person, so doctor is the right person to judge the side effects and adjust the dosage accordingly.

Do not ignore the side effects as they can be serious too. For lightheadedness and dizziness, you can try getting up slowly from your bed from a lying or sitting position.

For side effects like constipation, you can switch to a simple diet which can aid the process of digestion properly. You should trust your doctor as your doctor knows the right dosage for you. Do not try to change the dosage or stop taking the medicine on your own. Your doctor will help you adjust your dose and reduce side effects gradually.

Altering the dosage of Fioricet on your own can lead to various other problems that you might not be able to understand and deal with. Consult your doctor if your current dose is causing any side effects.

For serious side effects, you must consult your doctor immediately to avoid adverse effects.

Knowing about Fioricet medicine

Fioricet medicine is a popular brand name for a blend of three drugs, which comprise of caffeine, butalbital and acetaminophen. The combination of these three drugs is used to treat migraines, tension headaches and different types of other pain ailments. Fioricet is not clearly labeled as a common pain reliever. The medicine is  available only with your doctor’s prescription, but if you are suffering from tension headache, it is better to speak to your doctor about the effects of using Fioricet to manage serious or recurring headaches.

Fioricet was approved by FDA in 1984 and Novartis Pharmaceuticals was its original manufacturer. In 2003, Watson pharmaceuticals now known as Actavis, purchased the rights to sell Fioricet. Many manufacturers are now selling Fioricet in generic form as well. The original formulation of the medicine included

  • 50 milligrams butalbital
  • 40 mg of caffeine
  • 320 mg – acetaminophen

Mechanism of formulation

Butalbital is a type of sedative used as a muscle relaxer in Fioricet, the butalbital is used to alleviate the muscle tension that occurs due to tension headaches. One should take Fioricet as prescribed by the doctor and should avoid the dependency on drug. Do not exceed the recommended dose.

Caffeine is used in Fioricet to improve the efficacy of acetaminophen. When taking Fioricet, the patients should not take substances that contain caffeine to avoid overdose and nervousness caused by high consumption of caffeine.

Acetaminophen is a popular pain reliever, which is also available   over the counter. Since acetaminophen is easily available, the patients taking Fioricet should be familiar with the contents of any other medications, they are using to prevent overdose.

According to FDA guidelines, the manufacturers are recommended to restrict the dose of acetaminophen in different prescription products.

Fioricet plus codeine

Another formula which includes Fioricet and codeine is also discovered by Actavis to deal with tension headaches. It comprises of 30 mg- codeine along with other 3 drugs and contains increased dose of acetaminophen, which is 325mg.

The Fioricet plus codeine comes in a black box with a warning about how it can be toxic for your liver, lead to respiratory problems and death in kids caused by codeine.

Addiction and Abuse

In Fioricet, the sedative known as butalbital is present, which belongs to the class of certain drugs known as barbiturates, a depressant that can affect your central nervous system. It has the ability to cause psychological and physical dependence which can result in abuse.

Those who take too much medicine (Fioricet) may discover that they are stress free and feel relaxed. This makes them addictive to the drug as they start taking high doses to get the satisfactory results.  Some people say that they feel intoxicated. However, people can get into depression once the effect of medicine goes off.

Despite of its risks, Fioricet is an effective medicine to manage migraines and tension headaches. When used under the supervision of an experienced doctor and when taken as prescribed by the doctor can help people get great results.

Is it legal to buy Fioricet and Gabapentin Online ?

Yes, it is Legal to buy certain prescription drugs online if they are located and Licensed in the USA. The questionaire is what the Doctor needs to know BEFORE giving you a prescription. To just write out prescriptions would be illegal.

Fioricet and gabapentin are not controlled subsctance, so it is Ok to get your orders online. But you must complete your questionnaires very carefully and honestly. Your IP address also maybe reordered to check whether you are a legal US nature man or woman.

Controlled substances are not allowed online. But some countries controlled some medicines but some other countries even list it as over the counter medicines. You must follow your own country’s law.

How should I take Fioricet ?

Take Fioricet exactly as prescribed. Follow all directions on your prescription label. Do not take more of this medication than recommended. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take the medicine with food or milk if it upsets your stomach.

Store Fioricet at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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.

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.

Why Fioricet is Controlled but Fiorinal is controlled ?

Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.  The max dose of acetaminophen per day is 4000 mg, and since there’s only 325 mg in Fioricet, you’ll have to take a lot at once or take them for a long time to get the damage from acetaminophen, whereas someone on warfarin takes aspirin and isn’t aware of it the effects could be immediate….The fatal liver damage from acetaminophen comes when you take it with alcohol, so if you don’t take your Fioricet with a shot you should be ok at this dose

Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine. Fiorinal is scheduled because drug abusers can easily perform an “acid wash” to remove the aspirin (acetylsalicylic acid) component. It is much more difficult to remove the acetaminophen component in Fioricet. 

The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet.

The interesting thing is that Fiorinal is a scheduled class III substance, while Fioricet has a non-scheduled status. It seems really strange because both combinations contain equal amount of the controlled substance butalbital.

Exceptions from the scheduling have been made if the drug meets the requirements of section 811(g) (3) (A) of the Controlled Substances Act2. The exemption requires that one of the active ingredients be a non-narcotic controlled substance and one of the others be a non-scheduled compound. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophenn) is added. The ratio required for exemption is 70 mg of acetaminophen to 15 mg of butalbital. In contrast, the ratio of aspirin to butalbital is 188 mg to 15 mg.

The acetaminophen to butalbital ratio is approximately 97 mg to 15 mg in Fioricet, thus it is exempt from scheduling1. In Fiorinal the aspirin to butalbital ratio is approximately 97 mg to 15 mg, which is less than the 188mg:15mg ratio, so it is classified as a Schedule III substance.

Citation: Section 811(g)(3)(A) Controlled Substances Act

**Please note: Under the following states law, Fioricet is classified as a Schedule III controlled drug. **

  1. Georgia
  2. Maryland
  3. New Mexico

 Alabama Pharmacy State Board Newsletter that gives somewhat of an explanation:

In the past, there has been confusion over the controlled status of Fioricet. Fioricet is not scheduled federally. In 1980, a federal panel set forth criteria to except certain compounds if they were combined with butalbital and fell within the proper ratio of acetaminophen and butalbital. Fioricet met the criteria to be an excepted compound and was excepted in 1980.

Fiorinal is a much older drug than Fioricet and was released at a time when all butalbital-containing drugs were listed as Schedule-III. Butalbital was later removed from that listing but brand name Fiorinal was never taken off of the list. Fioricet came along after butalbital was removed from the list and it therefore carries no control status. However, butalbital does still carry some danger of dependence and there is no difference in the dependence levels between butalbital with aspirin and butalbital with acetaminophen.

Fioricet Drug Interactions that you should know

Drug interactions can change the effects of how the medication works for you or increase the risk of unwanted side effects.

Maintain a list of all other products you use apart from Fioricet. These products can be non prescription or prescription drugs, herbal supplements etc., and share the list with your pharmacist or doctor. Do not try to stop, change the dosage or start any of the medicines without consulting your doctor.

Some products that can interact with Fioricet comprise of

  1. Oxybate
  2. Sodium
  3. Darunavir
  4. Drugs that affect liver enzymes and flush out the medication from the body like macrolide antibiotics such as valproic acid, rasagiline,cimetedine, disulfiram, erythromycin MAO inhibitors, fluvoxamine, methylene blue, phenelzine moclobemide, ), isoniazid, procarbazine, selegiline, phenothiazines, tranylcypromine, lithium etc.,

Fioricet accelerates the elimination of other drugs from the body by affecting some liver enzymes. These drugs that are affected include, blood thinners like estrogen, doxycycline, felodipine, theophylline etc.,

Also let your doctor know about any other drowsiness causing drugs that you are using like anti-seizure drugs or antihistamines or medicines for anxiety or sleeping disorders, muscle relaxants, psychiatric medicines  or narcotic pain relievers.

Check the labels before you buy any medicines for yourself even for cough or cold because they may contain caffeine or other components that cause drowsiness. Remember some beverages also contain caffeine like colas, coffee, tea and energy drinks. Consult your pharmacist to know how you can use these products safely.

Fioricet can also reduce the potency of birth control hormonal pills, ring or patch. This can lead to pregnancy. Consult your pharmacist or doctor if you should use other birth control options while using this medicine. Also let your doctor know if you experience breakthrough bleeding or new spotting as this can be the indication that your birth control technique is not functioning properly.

Fioricet can also interfere with certain laboratory or medical tests, resulting in giving incorrect test results. Make sure your doctor or laboratory personnel know that you are using this drug.

Alcohol and Fioricet

Check with your doctor regarding alcohol consumption while taking Fioricet. The medicine might increase the intoxication effects of alcohol. Drinking when you are on Fioricet may result in liver damage due to acetaminophen.

It is very important to know about the drug interaction with all other medications you are using including supplements and simple medications used for cold and cough. Knowing about the contents of medications you are using, you can easily know about the risk linked to drug interactions. You can also let your doctor know about the other medications you are using so that your doctor helps you know Fioricet interactions with those medicines.

You can avoid the risks linked to drug interactions and in case you experience any unusual symptoms, you can connect with your doctor. Though Fioricet is quite useful, it comes with a lot of restrictions too, you just need to take care of those limitations to get better results. Try to get maximum benefits from your drug.

Fioricet and Pregnancy – Precautions and care

Fioricet is known to be a prescription medicine used to treat tension headaches. Well, if you are pregnant and on Fioricet, then there are certain precautions you need to take and you should know about the side effects of Fioricet during pregnancy. You are going through an important phase of your life, when you are carrying a new life inside you. You need to make sure that usage of Fioricet doesn’t harm your unborn baby. Let us learn about the precautions, dosage and care that you need to know while using Fioricet during pregnancy.

Well, if you are using Fioricet during your pregnancy, your doctor should not only consider the benefits of using the drug for you, but also weigh the possible risks to your unborn baby.

You should talk to your doctor as whether you should stop taking drug or need to adjust dose. It is still not known whether acetaminophen, caffeine and butalbital can cause harm to the fetus when recommended to a pregnant women or whether it can affect a woman’s reproduction capacity.

Some studies say that birth defects were observed due to exposure of butalbital during the first three months of pregnancy. Similarly consumption of caffeine during pregnancy has not shown any risks, but high doses of caffeine per day can lead to spontaneous abortion. So if you are pregnant try to minimize the intake of caffeine to avoid risks.

Fioricet consists of caffeine and the risks associated with its consumption in high dosages are miscarriage and poor growth of fetus. Looking at the formulation of Fioricet which consists of caffeine, Acetaminophen and butalbital, acetaminophen is used as antipyretic throughout the pregnancy. Acetaminophen is considered to be safe in pregnancy when taken for short durations in right dosage. Some studies say that use of acetaminophen in pregnant women can reduce the prostacyclin production.

Since there are inadequate studies available on risks of Fioricet during pregnancy, you can continue using Fioricet during your pregnancy if the benefit is greater than the possible risk to your unborn baby. It is better to speak to your doctor for the right dosage of Fioricet in pregnancy.

Fioricet should be used by pregnant women only when needed. Using it for a long term in high doses can cause harm to your unborn child as it can pre-pone your delivery date. Talk to your doctor to know the risks as well as the benefits.

There are some symptoms that you might experience because of pregnancy like headache, nausea, vomiting etc., if you feel the symptoms are severe, you can speak to your doctor immediately. During pregnancy you need to be extra careful  about the dose of Fioricet and your doctor can help you adjust the dose. Regular check-ups and monitoring unusual symptoms can help you stay away from risks. The drug has its benefits too, so trust your doctor and follow his instructions. Women using Fioricet also deliver healthy babies, so do not panic and take the right dose of Fioricet.

Right Dosage of Fioricet and treatment for overdose

Well, there are many risks associated with Fioricet, which includes drug dependency too. Drug dependency can lead to other risks and to avoid the risks it is always better to take recommended dose of Fioricet. Taking the right dosage can prevent the risk and give you better results. You can also do a little bit of research to know about the medicine so that you can know about the positive and negative effects of Fioricet.


The recommended dose is.

  • 1-2 capsules every after every 4 hours as required for pain relief
  • Do not exceed the limit of 6 capsules.

Fioricet should not be used for a long term, because of its risk associated with dependency or drug abuse.

Fioricet- Overdose

If you take high doses on Fioricet, it may result in toxicity because of acetaminophen and butalbital than caffeine as caffeine is present in small amounts.

If you experience extreme drowsiness or confusion or other unusual symptoms, consult  your doctor immediately.

FioricetTreatment of overdose

The treatment of overdose in case of Fioricet becomes quite complicated when the user takes high dosage of the two highly toxic substances present in Fioricet. Overdose of Fioricet normally results in highly toxic amounts of butalbital and acetaminophen. Since these two substances are consumed at once, needs treating the overdoses of both substances. Overdose of Fioricet in some cases where the person is not prescribed the medicine, needs an emergency medical attention.

Overdose of Fioricet can be fatal too and symptoms may not be seen for a couple of hours after the consumption.  Once initial symptoms of overdose appear, they can progress rapidly and one might fail to reach the medical care centre in time.

In case of overdose of Fioricet,  it is recommended to consult centre for poison control. Immediate treatment consists of cardio respiratory function support and methods to eliminate drug absorption. Some of the supportive measures that can be employed are intravenous fluids, oxygen and vasopressors. Controlled ventilation should be considered too.

In order to get best results, NAC should be managed immediately where there are chances of evolving or impending liver injury. In case of severe intoxication, vigorous supportive therapy is required.  Procedures to limit the drug absorption should be carried out immediately.

After the treatment is given for overdose on Fioricet, subsequent care is necessary to monitor the addiction problem and drug abuse.

FioricetRehab Treatment

The Fioricet rehab treatment starts with the process of detoxification.  This process helps reduce the dosage of Fioricet until they stop using the drug completely.  The detoxification process helps eliminate the physical dependency of the patient on Fioricet. The remaining treatment program entirely depends on dealing with psychological aspect of drug addiction.

Well, in cases of overdose of Fioricet, immediate medical attention is required to reduce the drug absorption so that the patient can get back to normal routine. Later they can join rehab centre to overcome drug addiction.

Mikart generic fioricet with imprint ”MIA 110” is manufactured by Mikart, Inc

It’s a white oval pill , only it says on it MIA 110 ## The white oval pill in description is a combination of Acetaminophen (325 mg) + Butalbital (50 mg) + Caffeine (40 mg). This is most commonly used to treat migraines and tension headaches.

Pill imprint MIA 110 has been identified as Acetaminophen, butalbital and caffeine 325 mg / 50 mg / 40 mg.

Acetaminophen/butalbital/caffeine is used in the treatment of headache and belongs to the drug class analgesic combinations. Risk cannot be ruled out during pregnancy. Acetaminophen/butalbital/caffeine 325 mg / 50 mg / 40 mg is not a controlled substance under the Controlled Substance Act (CSA).

Acetaminophen, butalbital and caffeine

Imprint:MIA 110
Strength:325 mg / 50 mg / 40 mg
Shape:Elliptical / Oval
Availability:Prescription only

Drug Class: Analgesic combinations

Pregnancy Category:C – Risk cannot be ruled out
CSA Schedule:Not a controlled drug Manufacturer: Mikart, Inc.


This tablet contains Acetaminophen, Butalbital and Caffeine, it is a generic for Fioricet, most commonly used to treat migraines. Common side effects may include: nausea, drowsiness, dizziness and stomach irritation.

LCI Fioricet is Not a controlled drug Manufacturer : Lannett Company, Inc.

Pill imprint LCI 1695 has been identified as Acetaminophen, butalbital and caffeine 325 mg / 50 mg / 40 mg.

Acetaminophen/butalbital/caffeine is used in the treatment of headache and belongs to the drug class analgesic combinations. Risk cannot be ruled out during pregnancy. Acetaminophen/butalbital/caffeine 325 mg / 50 mg / 40 mg is not a controlled substance under the Controlled Substance Act (CSA).


Fioricet and is a round, blue tablet; but is not the Westward brand I usually receive.  This tablet has the letters LCI printed on one side and the numbers 1655 on the other side

Acetaminophen, butalbital and caffeine

Strength:325 mg / 50 mg / 40 mg
Availability:Prescription only

Drug Class:Analgesic combinationsPregnancy Category:C – Risk cannot be ruled out

CSA Schedule: Not a controlled drug Manufacturer : Lannett Company, Inc.

Lannett Company, Inc. was Founded in 1942, Lannett develops, manufactures and distributes generic prescription pharmaceutical products in tablet, capsule and oral liquid forms to customers throughout the United States. Lannett markets its products primarily to drug wholesalers, retail drug chains, distributors, and government agencies.

We employ a staff of dedicated people who work together to produce drug products that sick people can afford to buy that will treat their illness, make them well, reduce suffering and improve the quality of their lives.

Lannett Receives FDA Approval for Butalbital, Acetaminophen and Caffeine Tablets USP, 50mg/325mg/40mg


PHILADELPHIA–(BUSINESS WIRE)–Lannett Company, Inc. (NYSE MKT: LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Butalbital, Acetaminophen and Caffeine Tablets, USP, 50mg/325mg/40mg. According to IMS, for the year ended July 2012 total sales of Butalbital, Acetaminophen and Caffeine Tablets at Average Wholesale Price (AWP) were approximately $30 million, of which about $15 million was for the brand version, Fioricet®. The company expects to commence shipping the product next month.

“Sales of Butalbital, Acetaminophen and Caffeine Tablets have been climbing five percent annually over the past three years,” said Arthur P. Bedrosian, president and chief executive officer of Lannett. “This approval continues the positive momentum we have generated over the last several quarters. We have a number of product applications pending at the FDA, including several late-stage, large market opportunity drugs. Our active product development program is focused on expanding our pain management franchise. We thank our local FDA representatives, as well as the reviewers at the Office of Generic Drugs, who were helpful in getting our product applications approved.”

About Lannett Company, Inc.:

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications. For more information, visit the company’s website at www.lannett.com.

This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statements, including, but not limited to, successfully commercializing Butalbital, Acetaminophen and Caffeine Tablets, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the difficulty in predicting the timing or outcome of FDA or other regulatory approvals or actions, the ability to successfully commercialize products upon approval, Lannett’s estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, and other risk factors discussed in the company’s Form 10-K and other documents filed with the Securities and Exchange Commission from time to time. These forward-looking statements represent the company’s judgment as of the date of this news release. The company disclaims any intent or obligation to update these forward-looking statements.

Fioricet Images

The combination of acetaminophen, butalbital, and caffeine is called Generic fioricet and it is used to treat tension headaches that are caused by muscle contractions. It is also widely used for migraine, cluster headache and all kinds of headache even neck pain.

cetaminophen 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.

The usual adult dose is 1-2 tablets every four hours as needed, not exceeding six tablets in a 24-hour period.

There are a lot of manufacturers can produce generic fioricet because they are just compound of butalbital, apap, caffeine. What we can find the fioricet manufacturers are as following: http://dealpain.net/2015/12/03/how-many-manufacturers-produce-generic-fioricet-and-which-one-is-the-best/

Acetaminophen, butalbital, and caffeine may also be used for purposes not listed in this medication guide. The images of generic fioricet are listed below:











Generic Fioricet manufacturer list with their NDC number

Fioricet and Esgic are brand names of a combination of butalbital (a barbiturate), acetaminophen and caffeine which is indicated for the treatment of tension headaches, muscle contraction headaches and post-dural puncture headaches. Although not indicated, they are commonly used to treat migraines and other painrelated ailments. Fioricet is indicated for the treatment of muscle tension or muscle contraction headaches. It is also commonly prescribed for migraines although it is not FDA indicated for this use in the United States. The usual adult dose is 1-2 tablets every four hours as needed, not exceeding six tablets in a 24-hour period.

There are a lot of manufacturers can produce generic fioricet because they are just compound of butalbital, apap, caffeine. What we can find the fioricet manufacturers are as following:


Watson Fioricet. Manufactured By: Nexgen Pharma, INC – NDC:0591-2640-01


Cardinal Health NDC 55254-2073-0


Mikart, INC NDC 46672-059-10


West-Ward Fioricet, West-Ward Pharmaceutical Corp. NDC 0143-1115-01