Fiorinal is a combination medication that contains three active ingredients: butalbital (a barbiturate), aspirin (an NSAID), and caffeine (an adenosine antagonist). It's used to treat symptoms of tension headaches in adults. The brand name Fiorinal has been discontinued, but there are still lower-cost generic pills available. The medication is taken by mouth every 4 hours. The most common side effects are sleepiness and dizziness. This medication is a schedule III controlled substance because it has a risk of misuse and dependence.
Tension headaches in adults
Fiorinal is a combination of three medications that work together to help relieve pain from tension headaches.
Butalbital is a barbiturate. It works by raising the levels of certain chemicals that have a calming and relaxing effect in the brain.
Aspirin is a non-steroidal inflammatory drug (NSAID). It stops certain proteins in your body from causing pain and inflammation.
Caffeine is an adenosine antagonist. It blocks the activity of a natural chemical in the body called adenosine. It's unclear how exactly caffeine works for headaches, but it's thought to boost the pain-relieving activity of aspirin.
Fiorinal can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Older than 65 years of age | History of stomach bleeding or ulcers | History of conditions that cause bleeding | Drinking 3 or more alcoholic beverages per day
The aspirin in Fiorinal can irritate your stomach and can feel like stomach pain or heartburn. It can also lead to serious stomach problems, including bleeding and ulcers in this area. Stop using Fiorinal and get medical attention right away if you have stomach pain that doesn't get better; vomit or cough up blood or bits that look like coffee grounds; or have bloody or black, tarry stools. These can be signs of stomach bleeding or a stomach ulcer, and you should see a healthcare professional (HCP) to help manage and treat it.
Risk factors: History of kidney or liver problems | History of heart failure | Taking Fiorinal for a long time | Taking certain blood pressure medications (water pills, ACE inhibitors, or ARBs) | Low fluids in the body | Age 65 years and older
Fiorinal contains aspirin. At high doses, aspirin can sometimes raise the risk for kidney damage. The risk might be higher if you're taking certain medications that can harm your kidneys, such as ACE inhibitors (e.g., lisinopril (Zestril)) and diuretics (water pills). Stop taking Fiorinal and let your prescriber know if you're not urinating as often as usual or if you have muscle weakness, numbness in your arms or legs, or a fast heartbeat. These can be signs of kidney damage.
Risk factors: Children 18 years or younger recovering from chickenpox or flu-like symptoms
Fiorinal isn't approved for children. This medication contains aspirin. And aspirin use in children, especially those recovering from flu-like symptoms or other viruses, is linked to a rare but serious and life-threatening condition called Reye's syndrome. Early symptoms can include vomiting, headache, confusion, and changes in behavior. If left untreated, it can lead to seizures and loss of consciousness. Ask a healthcare professional for recommendations on treating headaches in children.
Risk factors: Taking higher doses of Fiorinal | Age 65 years or older | Drinking alcohol | Taking other medications that can cause sleepiness
Fiorinal contains butalbital, which can cause extreme sleepiness and lower your ability to think, react, and focus. Your risk is higher if you drink alcohol with Fiorinal. Your risk is also higher if you take other medications that can make you sleepy or have "brain fog", such as benzodiazepines and muscle relaxants. Make sure you know how Fiorinal affects you before driving a car or doing activities that require your concentration. Talk to your HCP right away if you feel too sleepy from taking Fiorinal.
Risk factors: Taking Fiorinal longer than prescribed | Taking higher doses of Fiorinal than prescribed | Taking Fiorinal more often than prescribed
Fiorinal contains butalbital, which has a potential for misuse. Misuse can lead to accidental overdose, which can be life-threatening. Call for emergency medical help if you have symptoms like extreme sleepiness, trouble breathing, dizziness, confusion, or loss of consciousness. These can be signs that you might've taken too much butalbital.
Butalbital can also become habit-forming, especially if it's taken for a long period of time. And when you suddenly lower your dose or stop taking the medication, you might have withdrawal symptoms, like restlessness, trouble sleeping, and shakiness. To lower the risk of physical dependence, don't take Fiorinal longer than prescribed, at higher doses than prescribed, or more often than prescribed. Talk to your prescriber about how to stop the medication safely if you no longer want to take Fiorinal.
Severe allergic reactions to Fiorinal are possible. These reactions can include anaphylaxis (closing of the throat), which can be life-threatening. Let your prescriber know if you have an allergy to aspirin or other NSAIDs before you start taking Fiorinal. Call 911 if you have hives; trouble breathing; or swelling of your face, lips, or tongue.
Fiorinal can also cause drug reaction with eosinophilia and systemic symptoms (DRESS). Get medical attention right away if you notice symptoms of DRESS, such as fever, rash, and swollen lymph nodes.
Source:Â DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common or rare
may mean that a serious allergic reaction is occurring
Bluish discoloration or flushing or redness of skin (occurring together with other effects listed in this section)
coughing, shortness of breath, troubled breathing, tightness in chest, or wheezing
difficulty in swallowing
dizziness or feeling faint (severe)
hive-like swellings (large) on eyelids, face, lips, or tongue
stuffy nose (occurring together with other effects listed in this section)
Rare
Bleeding or crusting sores on lips
fever with or without chills
red, thickened, or scaly skin
sores, ulcers, or white spots in mouth (painful)
sore throat (unexplained)
tenderness, burning, or peeling of skin
Symptoms of overdose
Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe, especially with products containing caffeine)
convulsions (seizures, with products containing caffeine)
diarrhea (severe or continuing)
dizziness, lightheadedness, drowsiness, or weakness (severe)
frequent urination (for products containing caffeine)
hallucinations (seeing, hearing, or feeling things that are not there)
increased sensitivity to touch or pain (for products containing caffeine)
increased thirst
muscle trembling or twitching (for products containing caffeine)
nausea or vomiting (severe or continuing), sometimes with blood
ringing or buzzing in ears (continuing) or hearing loss
seeing flashes of "zig-zag" lights (for products containing caffeine)
slow, fast, or irregular heartbeat
slow, fast, irregular, or troubled breathing
slurred speech
staggering
stomach pain (severe)
uncontrollable flapping movements of the hands, especially in elderly patients
unusual movements of the eyes
vision problems
Check with your doctor as soon as possible if any of the following side effects occur:
Less common or rare
Bloody or black, tarry stools
bloody urine
confusion or mental depression
muscle cramps or pain
pinpoint red spots on skin
swollen or painful glands
unusual bleeding or bruising
unusual excitement (mild)
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Works well to treat tension headaches
Combines three medications into a single pill to relieve headache pain in different ways
Available as a lower-cost generic
Not recommended as a first-choice option for headaches because of the risk of rebound headaches
A controlled medication that can be habit-forming
Can cause bothersome withdrawal symptoms if you suddenly stop the medication after taking it for a long time
Hasn't been studied in children
Take Fiorinal exactly as prescribed. Don't change your dose or stop taking it without talking to your prescriber first. This medication can be habit-forming, and lowering the dose or stopping it too suddenly can lead to withdrawal symptoms, like anxiety and sleeping problems.
You can take Fiorinal with or without food. You can try taking the medication with food to help prevent or lessen stomach upset if it's hurting your stomach.
Even though Fiorinal contains caffeine, it also contains butalbital, which commonly causes sleepiness and dizziness. Don't drive or do anything requiring concentration until you know how this medication affects you.
Avoid alcohol while you're taking Fiorinal. Alcohol can worsen side effects like drowsiness and dizziness. It can also raise your risk for heartburn and stomach ulcers from the aspirin in the medication. What's more, alcohol can worsen headaches.
Avoid drinking coffee or consuming other sources of caffeine until you know how Fiorinal affects you. Each pill contains 40 mg of caffeine. Too much caffeine can make you nervous, shaky, or restless. It can also cause fast heart rate and trouble sleeping. Take the lowest possible amount of Fiorinal.
Tell your prescriber if you notice ringing in the ears or loss of hearing after you start using Fiorinal. These are possible side effects of aspirin. The ringing sound should go away and your hearing should return after you stop taking the medication.
Tell your care team about all the medications you're taking, especially if you're taking blood thinners, benzodiazepines, or barbiturates. Some medications can raise your risk for side effects when they're taken with Fiorinal. Your healthcare team can make sure all your medications are safe to take together.
Don't take multiple medications containing an NSAID unless your primary care provider specifically said it's okay because this can be harmful. Many over-the-counter medications for pain, headache, cold, and flu contain NSAIDs like aspirin and ibuprofen. Check with a member of your care team if you're not sure whether a medication contains an NSAID.
Dosage | Quantity | Price as low as | Price per unit |
---|---|---|---|
50mg/325mg/40mg | 30 capsules | $22.54 | $0.75 |
Each pill contains 50 mg of butalbital, 325 mg of aspirin, and 40 mg of caffeine.
The typical dose is 1 or 2 pills by mouth every 4 hours. The maximum dose is 6 pills per day.
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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.
Using medicines in this class 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.
Blood conditions
Porphyria (a medical condition that affects your skin and nerves)
Migraine - Excedrin Migraine
Minor aches and pains (e.g., headache, arthritis, muscle aches, toothache, menstrual cramps, common cold) - Excedrin Extra Strength
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Chartwell RX, LLC. (2023). Butalbital, aspirin, and caffeine capsule [package insert]. DailyMed.
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Drugs@FDA: FDA-Approved Drugs. (n.d.). Fiorinal. U.S. Food and Drug Administration.
Drugs and Lactation Database (LactMed®). (2023). Butalbital. National Institute of Child Health and Human Development.
Keilman, C., et al. (2022). Oligohydramnios. StatPearls.
Lipton, R. B., et al. (2017). Caffeine in the management of patients with headache. The Journal of Headache and Pain.
Millea, P. J., et al. (2002). Tension-type headache. American Family Physician.
National Institute of Diabetes and Digestive and Kidney Diseases. (2020). Porphyria.
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Suddock, J. T., et al. (2024). Barbiturate toxicity. StatPearls.
U.S. Food and Drug Administration. (2020). Nonsteroidal anti-inflammatory drugs (NSAIDs): Drug Safety Communication - Avoid use of NSAIDs in pregnancy at 20 weeks or later.
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