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Do not overuse Fioricet because you may become addicted to it and have difficulty stopping it.
Over-use of Fioricet can also result in a medication-overuse headache (also known as a rebound headache) which occurs when analgesics are taken too frequently to relieve a headache.
Never share your Fioricet with anybody else.
May be administered without regards to food; although food may decrease any reported stomach upset.
If you have been taking Fioricet regularly, or if you think you have become addicted to it, talk to your doctor about slowly withdrawing it, as sudden withdrawal may precipitate a withdrawal syndrome (symptoms include anxiety, dizziness, hallucinations, muscle twitching, nausea, seizures, sleeplessness, or tremor).
Fioricet can cause sedation and affect your ability to drive or operate machinery.
Do not drink more than two alcoholic drinks a day if you are a man or one alcoholic drink per day if you are women and taking Fioricet.
Talk to your doctor if you have any side effects of concern. Seek urgent medical advice if you develop an allergic-type reaction (difficulty breathing or swallowing, rash, or facial swelling) soon after taking Fioricet.
Not recommended for women who are pregnant or breastfeeding.
Fioricet contains acetaminophen which may be “hidden” in other cough/cold medicines. The total dose of acetaminophen from any source should not exceed 4000mg per day (24 hours).
Talk to your doctor or pharmacist before taking any other medications or natural products with Fioricet as it can interact with a large number of drugs.
If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:
Dizziness, drowsiness, lightheadedness, sedation, shortness of breath, nausea, vomiting, abdominal pain, or an intoxicated feeling are the most commonly reported side effects.
Other side effects, such as constipation, excessive sweating, itch, serious skin reactions, and mental confusion are less common.
Butalbital is habit-forming and there is a high risk of dependence with extended and repeated use of Fioricet. Therefore it is not considered a first-choice medicine for headaches.
May cause medication-overuse headache with repeated use and a withdrawal syndrome upon discontinuation.
The potential for liver damage with the acetaminophen component exists, even at recommended dosages. The risk is increased with higher dosages, with chronic alcohol use, with some medications, and in patients with significant liver disease.
May not be suitable for some people, including the elderly and people with kidney or liver disease.
Although Fioricet may be prescribed for migraine headaches, it is not FDA approved for this and evidence does not support its use for migraine.
Should not be used during pregnancy or breastfeeding.
May interact with a number of other medications including those that also cause sedation such as opioids, benzodiazepines, and sedating antihistamines. Alcohol should be avoided.
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.
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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.
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.
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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
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.
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
Cannabis
Carbamazepine
Fosphenytoin
Lixisenatide
Ospemifene
Phenytoin
Prednisone
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
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:
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.
fioricet
Butalbital, acetaminophen, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches.
Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.
Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.
When butalbital is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.
This medicine is available only with your doctor’s prescription.
This product is available in the following dosage forms:
Along with its needed effects, acetaminophen/butalbital/caffeine may cause some unwanted effects.
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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 while taking acetaminophen / butalbital / caffeine:
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 while taking acetaminophen / butalbital / caffeine:
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 of acetaminophen / butalbital / caffeine 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
Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.
Signs and Symptoms
Toxicity from barbiturate poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.
In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.
Treatment
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.
Butalbital: Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg.
As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller.
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The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days.
Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.
