Before Using

Drug information provided by: Micromedex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of butalbital, acetaminophen, caffeine, and codeine combination in the pediatric population. Safety and efficacy have not been established.

Fioricet® with codeine should not be used to relieve pain after surgery removal of tonsils and/or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of butalbital, acetaminophen, caffeine, and codeine combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Information about this butalbital-acetaminophen-caffeine-and-codeine-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Naltrexone
  • Riociguat

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenosine
  • Adinazolam
  • Alfentanil
  • Alprazolam
  • Amobarbital
  • Anileridine
  • Anisindione
  • Aprobarbital
  • Baclofen
  • Bromazepam
  • Brotizolam
  • Buprenorphine
  • Bupropion
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorzoxazone
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Clozapine
  • Cobicistat
  • Codeine
  • Dantrolene
  • Dezocine
  • Diazepam
  • Dicumarol
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Elvitegravir
  • Estazolam
  • Ethchlorvynol
  • Fentanyl
  • Flunitrazepam
  • Fluoxetine
  • Flurazepam
  • Halazepam
  • Hydrocodone
  • Hydromorphone
  • Imatinib
  • Ivabradine
  • Ketazolam
  • Levorphanol
  • Lorazepam
  • Lormetazepam
  • Meclizine
  • Medazepam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Metaxalone
  • Methocarbamol
  • Methohexital
  • Midazolam
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nifedipine
  • Nitrazepam
  • Nordazepam
  • Opium
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Pentazocine
  • Pentobarbital
  • Phenindione
  • Phenobarbital
  • Phenprocoumon
  • Piperaquine
  • Pixantrone
  • Prazepam
  • Primidone
  • Propoxyphene
  • Quazepam
  • Regadenoson
  • Remifentanil
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • Suvorexant
  • Tapentadol
  • Temazepam
  • Thiopental
  • Tizanidine
  • Triazolam
  • Ulipristal Acetate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Cannabis
  • Carbamazepine
  • Fosphenytoin
  • Imipramine
  • Isoniazid
  • Lixisenatide
  • Ospemifene
  • Perampanel
  • Phenytoin
  • Prednisone
  • Warfarin
  • Zidovudine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol
  • Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Cabbage
  • Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Addison's disease (an adrenal problem) or
  • Alcohol abuse, or history of or
  • Brain disease or
  • Breathing problems (eg, sleep apnea, respiratory depression) or
  • Drug abuse or dependence, or history of or
  • Enlarged prostate or
  • Head injury, history of or
  • Hypothyroidism (underactive thyroid) or
  • Stomach problems or
  • Trouble urinating or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Porphyria (enzyme problem) or
  • Surgery (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with these conditions.