Fioricet Side Effects

Fioricet Side Effects

What Is Fioricet?

Fioricet is a combination medication for chronic tension headaches. A tension headache causes moderate pain in the front, sides, or back of the head. Tension headaches are common and most people experience them occasionally. However, when people suffer from more than ten or fifteen headaches every month, a health care provider may write a prescription for Fioricet. Doctors sometimes also prescribe Fioricet for migraines, which are headaches that cause severe pain in one side of the head as well as hyper-sensitivity to light and sound.

Fioricet Chemical Structure
Fioricet Chemical Structure

What Are The Ingredients In Fioricet?

A combination medication is a drug which includes two or more pharmaceutical ingredients in a fixed dose. There are three ingredients in standard Fioricet: acetaminophen, butalbital, and caffeine. All three ingredients have different effects which combine to soothe headaches.

  • Acetaminophen is a medication which alleviates pain and reduces fever. It’s more widely-known by its brand name, Tylenol. Acetaminophen works by impairing the production of the prostaglandin chemical in the brain. This chemical activates pain signals in the nervous system.
  • Butalbital is a sedative barbiturate which stimulates the brain’s production of GABA. This neurotransmitter calms the nervous system by blocking signals among neurons. It also relaxes muscle tension in the head, thereby alleviating headaches. Butalbital is a Schedule III controlled substance in the United States.
  • Caffeine is a stimulant which raises a person’s blood pressure. While high blood pressure is not necessarily healthy, low blood pressure worsens headaches by causing blood vessels to expand and push against the brain. By raising raising blood pressure, caffeine causes blood vessels to constrict and increases blood flow. This effect helps relieve headaches.

With these three ingredients at work, Fioricet can be an effective source of headache relief. However, the medication also poses risks for side-effects, overdose, and addiction. For this reason, doctors usually refrain from prescribing Fioricet until safer over-the-counter medications fail to help their patients.

What is the Side Effects of Fioricet ?

Along with its needed effects, a medicine may cause some unwanted effects. 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:

Rare

    1. Bleeding or crusting sores on lips
    2. chest pain
    3. fever with or without chills
    4. hive-like swellings (large) on eyelids, face, lips, and/or tongue
    5. muscle cramps or pain
    6. red, thickened, or scaly skin
    7. shortness of breath, troubled breathing, tightness in chest, or wheezing
    8. skin rash, itching, or hives
    9. sores, ulcers, or white spots in mouth (painful)

Symptoms of overdose

    1. Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe, especially with products containing caffeine)
    2. convulsions (seizures) (for products containing caffeine)
    3. diarrhea, especially if occurring together with increased sweating, loss of appetite, and stomach cramps or pain
    4. dizziness, lightheadedness, drowsiness, or weakness, (severe)
    5. frequent urination (for products containing caffeine)
    6. hallucinations (seeing, hearing, or feeling things that are not there)
    7. increased sensitivity to touch or pain (for products containing caffeine)
    8. muscle trembling or twitching (for products containing caffeine)
    9. nausea or vomiting, sometimes with blood
    10. ringing or other sounds in ears (for products containing caffeine)
    11. seeing flashes of “zig-zag” lights (for products containing caffeine)
    12. shortness of breath or unusually slow or troubled breathing
    13. slow, fast, or irregular heartbeat
    14. slurred speech
    15. staggering
    16. swelling, pain, or tenderness in the upper abdomen or stomach area
    17. unusual movements of the eyes

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

    1. Confusion (mild)
    2. mental depression
    3. unusual excitement (mild)

Rare

    1. Bloody or black, tarry stools
    2. bloody urine
    3. pinpoint red spots on skin
    4. swollen or painful glands
    5. unusual bleeding or bruising
    6. unusual tiredness or weakness (mild)

Some side effects 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

    1. Bloated or “gassy” feeling
    2. dizziness or lightheadedness (mild)
    3. drowsiness (mild)
    4. nausea, vomiting, or stomach pain (occurring without other symptoms of overdose)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.

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.

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.

What are the possible side effects of acetaminophen, butalbital, and caffeine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

  • confusion, seizure (convulsions);
  • shortness of breath;
  • a light-headed feeling, like you might pass out; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • drowsiness, dizziness;
  • feeling anxious or restless;
  • drunk feeling; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The Following Fioricet Side Effects Have Also Been Reported:

Along with its needed effects, a medicine may cause some unwanted effects. 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:

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:

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 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
  • depression
  • earache
  • excess air or gas in the stomach or intestines
  • false or unusual sense of well-being
  • full feeling
  • hearing loss
  • heartburn
  • heavy eyelids
  • high energy
  • hot spells
  • hyperventilation
  • irritability
  • numbness
  • pain in the leg
  • passing gas
  • sluggishness
  • stuffy nose
  • tingling sensation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

 

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