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Fioricet (Butalbital / Acetaminophen / Caffeine) - Summary

 
 



Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.

 

FIORICET SUMMARY

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

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.


See all Fioricet indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Fioricet (Butalbital / Acetaminophen / Caffeine)

Symptomatic treatment of chronically recurring tension headache: a placebo-controlled, multicenter investigation of Fioricet and acetaminophen with codeine. [1987]
A double-blind, randomized, multicenter investigation was conducted to compare the efficacy and safety of Fioricet, acetaminophen with codeine, and placebo for the symptomatic treatment of tension headache. At the onset of a typical headache, the patients took two capsules of their assigned study medication and rated responses over the next four hours in three target symptoms areas: pain, emotional or psychic tension, and muscle contractions or stiffness in the head and neck...

Barbiturate withdrawal following Internet purchase of Fioricet. [2004.07]
CONCLUSIONS: The withdrawal state from barbiturates is similar to that from ethanol. Tolerance can develop with prolonged abuse, leading to escalating drug doses to achieve the desired effect. The suggested management of both types of withdrawal syndromes is similar, but the relative resistance of the behavioral and autonomic features in patients was remarkable. Physicians should be aware of the ease with which medications can be purchased without supervision from Internet pharmacies. The magnitude of the number of drugs that are made available through this means creates a proclivity to withdrawal states.

Butalbital in the treatment of headache: history, pharmacology, and efficacy. [2001.11]
Analgesics containing butalbital compounded with aspirin, acetaminophen, and/or caffeine are widely used for the treatment of migraine and tension-type headache. The butalbital-containing compounds are efficacious in placebo-controlled trials among patients with episodic tension-type headaches.Because of concerns about overuse, medication-overuse headache, and withdrawal, their use should be limited and carefully monitored.

more studies >>

Clinical Trials Related to Fioricet (Butalbital / Acetaminophen / Caffeine)

Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa [Recruiting]
Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to a healthy level, but high percentage of patients relapse during the first year following the discharge. The development of strategies to overcome this problem represents a priority for clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program based on cognitive dissonance theory developed for hospitalized patients.

TREXIMET� Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults [Completed]
Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)

more trials >>

Reports of Suspected Fioricet (Butalbital / Acetaminophen / Caffeine) Side Effects

Drug Ineffective (7)Headache (4)Pain (3)Hallucination (3)Insomnia (3)Agitation (2)Vomiting Projectile (2)Constipation (2)Influenza Like Illness (2)Haemorrhoidal Haemorrhage (2)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Fioricet has an overall score of 7.67. The effectiveness score is 8.67 and the side effect score is 7.33. The scores are on ten point scale: 10 - best, 1 - worst.
 

Fioricet review by 50 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   migraines
Dosage & duration:   l tablet taken onset of migraine for the period of still taking it at onsets
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   treatment benefits include migrain pain subsiding in about 20 minutes. No lingering fuzziness from taking this medication. Did not make me sleepy. If migrain pain appeared hours later another dose taken. This drug is especially handy for anyone with pre-menstural migrain headaches
Side effects:   for me there w4ere no treatment side effects. This medication did not cause drowsiness and I was able to keep doing my daily activiites. I also found that if I drank some coffee it would work even faster. It works in about 20 minutes after taking the medication.
Comments:   I take one tablet at the onset of of any migrain. After taking the tablet in about 20 minutes depending upon how fast I got to the pain. The medication started to work and within about 20 minutes the headache was all but forgotten. This is a safe great medication for anyone who suffers from migrain pain

 

Fioricet review by 34 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   migraines
Dosage & duration:   one to two tablets every four hours taken a copule times a month for the period of about 6 months
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   It effectively stopped migraine at the "aura" stage. No need to take any additional medications.
Side effects:   Massive dizziness/ "drugged" feeling. A feeling of being "out of it" --- unable to focus eyes, exhausted, etc. Impossible to function until the effect wore off. Not convinced this is the best option for migraine treatment. Although it was effective, the side effects were almost not worth it. There have got to be better options out there.
Comments:   Every time more than one pill was taken (where one was ineffective in stopping the progression of a migraine), massive dizziness and drugged feeling would result.

 

Fioricet review by 34 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   migraines
Dosage & duration:   one to two tablets every four hours taken a copule times a month for the period of about 6 months
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   It effectively stopped migraine at the "aura" stage. No need to take any additional medications.
Side effects:   Massive dizziness/ "drugged" feeling. A feeling of being "out of it" --- unable to focus eyes, exhausted, etc. Impossible to function until the effect wore off. Not convinced this is the best option for migraine treatment. Although it was effective, the side effects were almost not worth it. There have got to be better options out there.
Comments:   Every time more than one pill was taken (where one was ineffective in stopping the progression of a migraine), massive dizziness and drugged feeling would result.

See all Fioricet reviews / ratings >>

Page last updated: 2006-01-31

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