Get emergency medical help if you have signs of an allergic reaction to Fioricet: 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 Fioricet 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.
For the Consumer
Applies to acetaminophen / butalbital / caffeine: oral capsule, oral solution, oral tablet
Along with its needed effects, acetaminophen / butalbital / caffeine 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 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
- 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
We do not suggest you to take Fioricet or Gabapentinfor a long time, you need go to your local health professional to treat your pain without prescription. You can also take some natural health products to relieve your pain.
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For Healthcare Professionals
Applies to acetaminophen / butalbital / caffeine: oral capsule, oral liquid, oral tablet
Nervous system
Butalbital/Acetaminophen/Caffeine:
Common (1% to 10%): Drowsiness, lightheadedness, dizziness, sedation
Uncommon (0.1% to 1%): Headache, shaky feeling, tingly, fainting, numbness, seizures, mental confusion, excitement or depression due to intolerance
Caffeine:
Frequency not reported: Tremor
General
The most frequently reported adverse events have included drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.
Hepatic
Acetaminophen:
Frequency not reported: Liver failure
Acute liver failure has been reported with acetaminophen use; many case have been associated with use at doses in excess of 4 g/day, and often involving more than 1 acetaminophen-containing product.
Gastrointestinal
Common (1% to 10%): Nausea, vomiting, abdominal pain
Uncommon (0.1% to 1%): Dry mouth, difficulty swallowing, heartburn, flatulence, constipation
Renal
Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Diuresis
Caffeine:
Frequency not reported: Nephrotoxicity
Hypersensitivity
Uncommon (0.1% to 1%): Allergic reactions
Postmarketing reports: Anaphylaxis
Acetaminophen:
Postmarketing reports: Anaphylaxis
Hematologic
Acetaminophen:
Frequency not reported: Thrombocytopenia, agranulocytosis
Dermatologic
Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Hyperhidrosis, pruritus
Frequency not reported: Toxic epidermal necrolysis, erythema multiforme
Acetaminophen:
Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
Frequency not reported: Rash
Several cases of dermatologic reactions including toxic epidermal necrolysis and erythema multiforme have been reported.
Respiratory
Common (1% to 10%): Shortness of breath
Uncommon (0.1% to 1%): Nasal congestion
Cardiovascular
Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Tachycardia
Caffeine:
Frequency not reported: Cardiac stimulation
Other
Common (1% to 10%): Intoxicated feeling
Uncommon (0.1% to 1%): Fatigue, high energy, heavy eyelids, sluggishness, hot spells, fever, earache, tinnitus
Metabolic
Caffeine:
Frequency not reported: Hyperglycemia
Musculoskeletal
Uncommon (0.1% to 1%): Leg pain, muscle fatigue
Psychiatric
Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Agitation, euphoria
Caffeine:
Frequency not reported: Irritability, dependence