What is the side Effects of Fioricet ?

Fioricet side effects

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.

We do not suggest you to take this medicine for a long time. You can try to become a usana associate and eat health organic food to get rid of your headache or nerve pain. You can also try their whitening toothpaste to make you more beautiful and get rid of your pain. check more detail for usana Proflavanol® C100, USANA® Probiotic and Vita Antioxidant™

What should I know about storage and disposal of Fioricet ?

Keep Fioricet in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.

What special precautions should I follow if I want to take Fioricet?

Before taking acetaminophen, Butalbital, Caffeine,

  • tell your doctor and pharmacist if you are allergic to acetaminophen, butalbital, caffeine, or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially anticoagulants (‘blood thinners’) such as warfarin (Coumadin), antidepressants, antihistamines, pain medications, sedatives, sleeping pills, tranquilizers, and vitamins. Many nonprescription pain relievers contain acetaminophen. Too much of this drug can be harmful.
  • tell your doctor if you have or have ever had liver disease, porphyria, or depression.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking this medication, call your doctor.
  • you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
  • remember that alcohol can add to the drowsiness caused by this drug.

Why Fioricet is not a controlled substance ?

Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.

New capsule reformulation of Fioricet contains: 300 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.

Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine.

The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet.

The interesting thing is that Fiorinal is a scheduled class III substance, while Fioricet has a non-scheduled status. It seems really strange because both combinations contain equal amount of the controlled substance butalbital.

Two possible reasons:

  1. The aspirin is easier to remove than the Tylenol (APAP).
  2. Due to the protein binding of APAP. From what I can ascertain, since both butalbital and APAP are protein bound, there is more free butalbital in the Fioracet. Butalbital is metabolized to phenobarbital to exert it’s effects, and this metabolite can reach higher concentrations at a faster rate than the Fiorinal can.

I haven’t found legit studies to back this up, but it’s reasonable and it’s what I can find. One other thought is that large doses of APAP are likely more harmful to the average person than large doses of aspirin. Aspirin can increase the risk of bleeding by a significant measure and can reduce kidney function, but APAP can do dangerous to deadly damage to your liver.

Exceptions from the scheduling have been made if the drug meets the requirements of section 811(g) (3) (A) of the Controlled Substances Act. The exemption requires that one of the active ingredients be a non-narcotic controlled substance and one of the others be a non-scheduled compound. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophen) is added.

According to the FDA, the issue boils down to a specific ratio of aspirin or acetaminophen to butalbital. Fiorinal® is required to have at least 188 mg of aspirin for every 15 mg of butalbital (188:15) to meet CSA exemption. The ratio needed for Fioricet® is 70 mg of acetaminophen for every 15 mg of butalbital (70:15). These ratios were based on what the FDA believed were adequate amounts of nonnarcotic to reduce the abuse potential of butalbital.

The acetaminophen to butalbital ratio in new and old formulation of Fioricet:

Old formulation:

325 mg Acetaminophen / 50 mg Butalbital

97 mg Acetaminophen to 15 mg Butalbital (To be exempt, ration requires at least 70 mg or more Acetaminophen for every 15 mg Butalbital included in formulation.

New Formulation:

300 mg Acetaminophen / 50 mg Butalbital

90 mg Acetaminophen to 15 mg Butalbital (To be exempt, ration requires at least 70 mg or more Acetaminophen for every 15 mg Butalbital included in formulation.

So both new and old formulation of Fioricet by law shall be exempt from controlled substance requirements.

The aspirin to butalbital ratio in Fiorinal:

325 mg Aspirin / 50 mg Butalbital

97 mg Aspirin to 15 mg Butalbital (To be exempt, ration requires at least 188 mg or more Aspirin for every 15 mg Butalbital included in formulation.

Therefore Fiorinal is classified as a Schedule III substance.