Fioricet contains 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.
Fioricet is used to treat tension headaches that are caused by muscle contractions.
Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is supplied in tablet form for oral administration.
Each tablet contains the following active ingredients:
butalbital USP . . . . . . . . . . . .50 mg
acetaminophen USP . . . . . . 325 mg
caffeine USP . . . . . . . . . . . . .40 mg
Butalbital has generalized depressant effect on central nervous system and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects mediated by a metabolite which acts at cannabinoid receptors, contrary to popular belief it is not an antiinflammatory at safe levels (it becomes toxic at doses above 1,000mg per dose and/or 3,000mg per day). Caffeine is thought to produce constriction of cerebral blood vessels and serves to counteract the sedative effect of butalbital.
Butalbital has a half-life of about 35 hours. Acetaminophen has a half-life of about 1.25 to 3 hours, but may be increased by liver damage and after an overdose. Caffeine has a half-life of about 5 to 7 hours
Fioricet works through a combination of these three ingredients to provide relief from tension headaches and migraines. Acetaminophen helps to reduce pain and fever, butalbital relaxes muscle tension and induces sedation, and caffeine enhances the overall effectiveness of the medication.
It’s important to use Fioricet exactly as prescribed by a healthcare provider and to follow the recommended dosage and instructions. Overuse or misuse of Fioricet, particularly due to its butalbital content, can lead to dependence, tolerance, and withdrawal symptoms. Additionally, Fioricet contains acetaminophen, so it’s essential to avoid exceeding the maximum daily dose to prevent liver toxicity. As with any medication, it’s important to discuss any questions or concerns with a healthcare professional before using Fioricet.
Fioricet Side Effects ?
Fioricet, like any medication, can cause side effects. It’s important to be aware of potential side effects and to discuss any concerns with your healthcare provider. Some common side effects of Fioricet may include:
- Drowsiness: Because Fioricet contains butalbital, a central nervous system depressant, drowsiness or sedation is a common side effect.
- Dizziness: Some individuals may experience feelings of dizziness or lightheadedness while taking Fioricet.
- Nausea or Vomiting: Acetaminophen, one of the active ingredients in Fioricet, can sometimes cause gastrointestinal upset, including nausea or vomiting.
- Stomach Upset: Some people may experience stomach discomfort, abdominal pain, or heartburn while taking Fioricet.
- Feeling Anxious or Agitated: In some cases, Fioricet may cause feelings of anxiety or agitation, especially in individuals sensitive to butalbital.
- Trouble Sleeping: Fioricet can disrupt normal sleep patterns and may cause difficulty falling asleep or staying asleep.
- Headache Rebound: Overuse of Fioricet can lead to a rebound effect, where headaches return or worsen when the medication wears off.
- Liver Toxicity: Fioricet contains acetaminophen, which can cause liver damage if taken in high doses or over a long period. Taking more than the recommended dose of Fioricet or using it in combination with other acetaminophen-containing medications can increase the risk of liver toxicity.
- Dependency and Withdrawal: Butalbital, a barbiturate found in Fioricet, has the potential for dependence and withdrawal symptoms if used excessively or for prolonged periods.
- Allergic Reactions: While rare, some individuals may experience allergic reactions to Fioricet, which can include rash, itching, swelling, or difficulty breathing. Seek medical attention immediately if you experience any signs of an allergic reaction.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of butalbital, acetaminophen, and caffeine combination in children younger than 12 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of butalbital, acetaminophen, and caffeine combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving butalbital, acetaminophen, and caffeine combination.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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. 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.
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.
- Riociguat
- 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.
- Alfentanil
- Alprazolam
- Amobarbital
- Anisindione
- Aprobarbital
- Barbital
- Butabarbital
- Calcium Oxybate
- Capmatinib
- Carbamazepine
- Carisoprodol
- Chloral Hydrate
- Chlordiazepoxide
- Chlorzoxazone
- Clonazepam
- Clorazepate
- Dantrolene
- Darunavir
- Diazepam
- Dicumarol
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Drospirenone
- Esketamine
- Estazolam
- Eterobarb
- Ethchlorvynol
- Ethinyl Estradiol
- Etonogestrel
- Flunitrazepam
- Flurazepam
- Givosiran
- Halazepam
- Heptabarbital
- Hexobarbital
- Imatinib
- Iobenguane I 131
- Isocarboxazid
- Isoniazid
- Ketazolam
- Linezolid
- Lorazepam
- Lormetazepam
- Magnesium Oxybate
- Medazepam
- Mephenesin
- Mephobarbital
- Meprobamate
- Metaxalone
- Methocarbamol
- Methohexital
- Methylene Blue
- Midazolam
- Nifedipine
- Nitrazepam
- Norethindrone
- Norgestimate
- Norgestrel
- Oxazepam
- Ozanimod
- Pentobarbital
- Phenelzine
- Phenindione
- Phenobarbital
- Phenprocoumon
- Piperaquine
- Pixantrone
- Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
- Potassium Oxybate
- Prazepam
- Primidone
- Procarbazine
- Quazepam
- Rasagiline
- Ritlecitinib
- Safinamide
- Secobarbital
- Selegiline
- Sodium Oxybate
- Temazepam
- Thiopental
- Tranylcypromine
- Trazodone
- Triazolam
- Ulipristal
- Zotepine
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
- 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
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:
- Alcohol abuse, history of or
- Drug dependence, or history of or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Porphyria (an enzyme problem)—Should not be used in patients with this condition.
- Stomach problems—Use with caution. May make these conditions worse.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming and cause mental or physical dependence. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.
Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).
Dosing
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (capsules or tablets):
- For tension headaches:
- Adults and children 12 years of age and older—One or two capsules or tablets every 4 hours as needed. However, the dose is usually not more than 6 capsules or tablets per day. Do not exceed 4 grams (4000 milligrams) of acetaminophen (Tylenol®) per day.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For tension headaches:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress while you or your child are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine may make you dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.
Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
