Fiorinal contains a combination of aspirin, butalbital, and caffeine. Aspirin is a pain reliever, as well as an anti-inflammatory and a fever reducer. Butalbital is a barbiturate. It relaxes muscle contractions involved in a tension headache. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.
Fiorinal is used to treat tension headaches. This medicine is not for treating headaches that come and go.
Fiorinal may also be used for purposes not those listed in this medication guide.
Important information
You should not use Fiorinal if you have a stomach ulcer, severe liver disease, porphyria, a bleeding or blood clotting disorder, or if you are allergic to any NSAID.
Aspirin may cause stomach or intestinal bleeding, which can be fatal.
Stop using Fiorinal and call your doctor at once if you have: black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.
Aspirin should not be given to a child or teenager who has a fever.
Butalbital may be habit-forming. Misuse of habit-forming medicine can cause addiction, overdose, or death.
Before taking this medicine
Aspirin may cause stomach or intestinal bleeding, which can be fatal. This can occur without warning while you are taking this medicine.
You should not use Fiorinal if you are allergic to aspirin, butalbital, or caffeine, or if you have:
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stomach ulcer;
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severe liver disease;
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porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
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a bleeding or blood clotting disorder (such as hemophilia); or
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asthma, or a history of severe allergic reaction (sneezing, runny or stuffy nose, wheezing, shortness of breath) after taking aspirin or another NSAID (nonsteroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Celebrex, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.
To make sure Fiorinal is safe for you, tell your doctor if you have:
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liver or kidney disease;
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asthma or another respiratory disease;
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fluid retention;
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heart disease, congestive heart failure, high blood pressure;
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a history of head injury or brain tumor;
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a stomach or intestinal disorder;
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a thyroid disorder;
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enlarged prostate or urination problems; or
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Addison"s disease (an adrenal gland disorder).
It is not known whether Fiorinal will harm an unborn baby. If you use butalbital while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Tell your doctor if you are pregnant or plan to become pregnant.
Aspirin, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Aspirin use while breast-feeding could cause bleeding in the infant. You should not breast-feed while using Fiorinal.
Do not give this medicine to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye"s syndrome, a serious and sometimes fatal condition in children.
How should I take Fiorinal?
Take Fiorinal exactly as prescribed. Follow all directions on your prescription label. Never use Fiorinal in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your headache.
Butalbital may be habit-forming. Never share Fiorinal with another person, especially someone with a history of drug abuse or addiction. Keep Fiorinal in a place where others cannot get to it.
Misuse of habit-forming medicine can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.
If you need surgery, tell the surgeon ahead of time that you are using Fiorinal. You may need to stop using the medicine for a short time.
Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Fiorinal.
Store at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Fiorinal is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Fiorinal dosing information
Usual Adult Dose of Fiorinal for Pain:
1 to 2 tablets or capsules orally every 4 hours as needed.
Maximum of 6 tablets or capsules daily.
What happens if I miss a dose?
Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of butalbital can be fatal.
Overdose symptoms may include extreme drowsiness, confusion, restless feeling, insomnia, tremors, fast heart rate, vomiting, stomach pain, rapid breathing, feeling hot, ringing in your ears, weak or shallow breathing, seizure (convulsions), or fainting.
What should I avoid while taking Fiorinal?
This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you.
Ask a doctor or pharmacist before using any cough, cold, allergy, or pain medication. Aspirin and caffeine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains aspirin or caffeine.
Do not drink alcohol. Dangerous side effects, overdose, or death can occur when alcohol is combined with butalbital. Alcohol may increase your risk of stomach bleeding while you are taking aspirin.
Fiorinal side effects
Get emergency medical help if you have signs of an allergic reaction to Fiorinal: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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shallow breathing, slow heart rate;
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fast or pounding heart rate, muscle twitching;
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confusion, unusual thoughts or behavior;
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symptoms of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
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problems with urination; or
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easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.
Serious side effects may be more likely in older adults and those who are ill or debilitated.
Common Fiorinal side effects include:
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drowsiness, dizziness;
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nausea, gas, upset stomach, stomach pain; or
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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.
See also: Side effects (in more detail)
What other drugs will affect Fiorinal?
Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Fiorinal with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
You should not use Fiorinal if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
Tell your doctor about all your current medicines and any you start or stop using, especially:
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mercaptopurine;
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methotrexate;
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probenecid;
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insulin or oral diabetes medicine;
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a blood thinner - warfarin, Coumadin, Jantoven; or
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steroid medicine - prednisone, dexamethasone, and others.
This list is not complete. Other drugs may interact with aspirin, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
