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.
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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.
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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.
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)
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 >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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 |
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| | 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. |
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| | 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. |
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Page last updated: 2006-01-31
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