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Related to Fiorinal: Butalbital

butalbital, aspirin, and caffeine†

(byoo-tal-bi-tal, as-pir-in, & kaf-een) ,


(trade name),


(trade name),


(trade name)


Therapeutic: nonopioid analgesics
Pharmacologic: barbiturates
Pregnancy Category: C
†For information on aspirin component in formulation, see salicylates monograph


Relief of the symptom complex of tension (or muscle contraction) headaches (use should be short-term only as the butalbital component may be habit-forming).


Contains an analgesic (aspirin) for relief of pain, a barbiturate (butalbital) for its sedative effect, and caffeine, which may be of benefit in tension headaches.

Therapeutic effects

Decreased severity of pain with some sedation.


Absorption: Well absorbed.
Distribution: Widely distributed; crosses the placenta and enters breast milk.
Metabolism and Excretion: Butalbital primarily eliminated by kidneys as unchanged drug or metabolites (59–88% of dose); aspirin and caffeine primarily metabolized by liver.
Half-life: Butalbital = 35 hr; aspirin = 3 hr; caffeine = 3 hr.

Time/action profile

PO15–30 min1–2 hr30 hr


Contraindicated in: Hypersensitivity to individual components (cross-sensitivity may occur with NSAIDS); Bleeding disorders, thrombocytopenia, or vitamin K deficiency; Severe hepatic disease; Peptic ulcer disease; Porphyria; Pregnancy or lactation; Children (safety and effectiveness not established).
Use Cautiously in: History of suicide attempt or drug addiction; Chronic alcohol use; Severe hepatic or renal disease; Severe cardiovascular disease; Patients concomitantly receiving other CNS depressants; Patients concomitantly receiving warfarin therapy; Severe renal disease; Head injury; Elevated intracranial pressure; Hypothyroidism; Addison's disease; Benign prostatic hyperplasia; Asthma; Geriatric: Appears on Beers list. Geriatric patients are at increased risk for side effects (dosage reduction recommended).

Adverse Reactions/Side Effects

Central nervous system

  • drowsiness (most frequent)
  • confusion
  • delirium
  • depression
  • dizziness
  • excitation
  • headache (with chronic use)
  • insomnia
  • irritability
  • lethargy
  • nervousness
  • numbness
  • tingling

Ear, Eye, Nose, Throat

  • earache
  • nasal congestion
  • tinnitus


  • respiratory depression


  • palpitations
  • tachycardia


  • bleeding
  • constipation
  • dry mouth
  • dysphagia
  • epigastric distress
  • flatulence
  • heartburn


  • dermatitis
  • pruritis
  • rash
  • sweating


  • leg pain
  • muscle weakness


  • fever
  • physical dependence
  • psychological dependence
  • tolerance


Drug-Drug interaction

Additive CNS depression with other CNS depressants, including alcohol, antihistamines, antidepressants, opioid analgesics, and sedative/hypnotics.May increase the liver metabolism and decrease the effectiveness of other drugs including amiodarone, benzodiazepines, bupropion, calcium channel blockers, carbamazepine, citalopram, clarithromycin, cyclosporine, erythromycin, fluoxetine, fluvoxamine, glipizide, hormonal contraceptives, losartan, methadone, mirtazapine, nateglinide, nefazodone, nevirapine, phenytoin, pioglitazone, promethazine, propranolol, protease inhibitors, proton pump inhibitors, rifampin, ropinirole, rosiglitazone, selegiline, sertraline, tacrolimus, theophylline, venlafaxine, voriconazole, warfarin, and zafirlukast.MAO inhibitors, felbamate, primidone, and valproic acid may prevent metabolism and increase the effectiveness of butalbital.May increase the effect of warfarin, oral antidiabetic agents, insulin, 6–mercaptopurine, methotrexate, and NSAIDS.May decrease the effect of probenecid.St. John’s wort may decrease barbiturate effect.Concurrent use of kava kava, valerian, skullcap, chamomile, or hops can increase CNS depression.


Oral (Adults) 1–2 capsules or tablets (50–100 mg butalbital) every 4 hr as needed for pain (should not exceed 6 tablets or capsules/24 hr).

Availability (generic available)

Tablets: 50 mg butalbital/325 mg aspirin/40 mg caffeine
Capsules: 50 mg butalbital/325 mg aspirin/40 mg caffeine
In combination with: codeine. See combination drugs.

Nursing implications

Nursing assessment

  • Assess type, location, and intensity of pain before and 60 min following administration.
  • Prolonged use may lead to physical and psychological dependence and tolerance. This should not prevent patient from receiving adequate analgesia. Most patients who receive butalbital compound for pain do not develop psychological dependence.
  • Assess frequency of use. Frequent, chronic use may lead to daily headaches in headache-prone individuals because of physical dependence on caffeine and other components. Chronic headaches from overmedication are difficult to treat and may require hospitalization for treatment and prophylaxis.

Potential Nursing Diagnoses

Acute pain (Indications)
Risk for injury (Side Effects)


  • Do not confuse Fiorinal with Fioricet.
  • Explain therapeutic value of medication before administration to enhance the analgesic effect.
  • Regularly administered doses may be more effective than prn administration. Analgesic is more effective if given before pain becomes severe.
  • Medication should be discontinued gradually after long-term use to prevent withdrawal symptoms.
  • Oral: Should be administered with food, milk, or a full glass of water to minimize GI irritation.

Patient/Family Teaching

  • Instruct patient to take medication exactly as directed. Do not increase dose because of the habit-forming potential of butalbital. If medication appears less effective after a few weeks, consult health care professional. The dose of aspirin should not exceed the maximum recommended daily dose of 4 g/day. Chronic excessive use of >4 g/day (2 g in chronic alcoholism) may lead to hepatotoxicity, renal or cardiac damage.
  • Advise patients with tension headaches to take medication at first sign of headache. Lying down in a quiet, dark room may also be helpful. Medications taken for prophylaxis should be continued.
  • May cause drowsiness or dizziness. Advise patient to avoid driving and other activities requiring alertness until response to medication is known.
  • Caution patient to avoid concurrent use of alcohol or other CNS depressants.
  • Advise patient to report any signs of bleeding, bruising, or ringing in ears to a health care professional.
  • Advise patient to use an additional nonhormonal method of contraception while taking butalbital compound.

Evaluation/Desired Outcomes

  • Decrease in severity of pain without a significant alteration in level of consciousness.
Drug Guide, © 2015 Farlex and Partners


A sedative/ hypnotic of intermediate duration of action, which may be used for tension headaches.

Adverse effects
Dizziness, drowsiness, nausea, sedation, euphoria, addiction, diarrhoea, constipation, memory loss.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
References in periodicals archive ?
Fiorinal and Fiorinal C are indicated for the relief of tension-type headache and Visken /Viskazide for the treatment of mild-moderate hypertension.
Those who took two classes of prescription medications eI| drugs containing narcotics, such as Percocet, or drugs containing barbiturates, such as Fiorinal eI| were most likely to worsen, Lipton and colleagues reported in the journal Headache.
Just three months of taking simple analgesics (Advil, Motrin, etc.) for 15 days a month can trigger daily headaches; as can stronger medications such as triptans, opioids or combination analgesics (Fiorinal, Fioricet) taken just 10 days a month.
Fiorinal with codeine in the treatment of tension headache-the contribution of components to the combination drug.
In those days the typical patient was overusing Cafergot, Fiorinal, or Excedrin, and a few days in the hospital really did leave them feeling much better.
En decembre 1978, l'extraction d'une dent chez Laura Norberg [L.N.] la soulage de serieuses migraines, non sans qu'elle se fut toutefois accoutumee, dans l'entretemps, au medicament connu sous le nom de << Fiorinal >>.
The incident claimed four lives, injured 25, and caused more than $1 million in property damage--and was all the more tragic because the pilot had taken a migraine painkiller called Fiorinal that should have kept him grounded.
Medicare-Glaser Corp.,(80) in which the plaintiff's decedent was prescribed the drug Fiorinal following arthroscopic knee surgery.
Butalbital complex Aspirin/butalbital/caffeine(Fiorinal), acetaminophen/butalbital/caffeine (Fioricet) Pain medications Codeine, acetaminophen/hydrocodone (Vicodin), acetaminophen/oxycodone (Percocet), meperidine (Demerol), morphine Anti-nausea Prochlorperazine maleate (Compazine), medications promethazine (Phenergan), metoclopramide Medications that prevent migraines Beta blockers Propranolol (Inderal),metoprolol (Lopressor, Toprol-XL), timolol Tricyclic Amitriptyline (Elavil), nortriptyline (Pamelor) antidepressants Anti-epileptics Divalproex sodium (Depakote), Topiramate (Topamax) Calcium channel Diltiazem (Verapamil) blockers Popular pain medication can help.
Breckenridge also markets multiple ANDA products, including estradiol/norethindrone acetate tablets, 1 mg/0.5 mg (generic version of Activella); oxcarbazepine tablets (generic version of Trileptal); meloxicam tablets (generic version of Mobic); Ascomp with codeine (generic version of Fiorinal with codeine); butalbital, acetaminophen, caffeine and codeine phosphate (generic version of Fioricet with codeine); cyclobenzaprine (generic version of Flexerfl); methylprednisolone (generic version of Medrol); polyethylene glycol powder (generic version of Miralax); folic acid tablets; and prednisone 1-mg tablets.
Those who took two classes of prescription medications -- drugs containing narcotics, such as Percocet, or drugs containing barbiturates, such as Fiorinal -- were most likely to worsen, Lipton and colleagues reported in the journal Headache.
The other big offenders are Fioricet and Fiorinal, and opiates."