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.
Fiorinal is a combination of three medications that work together to help relieve pain from tension headaches.
| Common Brands | Fiorinal |
|---|---|
| Drug Class | Barbiturate / NSAID / Adenosine antagonist |
| Controlled Substance Classification | Schedule III |
| Generic Status | Lower-cost generic available |
| Availability | Prescription only |
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.
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.
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.
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.
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.
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.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Contact your healthcare provider immediately if you experience any of the following.
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.
Capsule| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 50mg/325mg/40mg | 30 capsules | $16.56 | $0.55 |
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.
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Fiorinal will not be safe for you to take.
Prescription savings
Stop paying too much for your prescriptions. Compare prices, get pharmacy coupons, and save up to 80%.
Find expert answers to your health questions so you can make the best decisions for yourself and your family.Health conditions
Medications & treatment
Access & affordability
Our monthly healthcare membership can help you save thousands on your prescription costs.Resources
Yes, Fiorinal is a schedule III controlled substance. This medication contains butalbital, which has a risk for misuse and dependence. To lower these risks, the healthcare professional will prescribe the lowest dose of Fiorinal for the shortest period of time needed to treat your headaches. Make sure to take Fiorinal exactly as prescribed.
Fiorinal and Fioricet both contain butalbital, which is a medication that can be misused and become habit-forming. Because of the butalbital, Fiorinal is classified as a controlled substance in all states. But because Fioricet also contains acetaminophen, Fioricet is a controlled substance only in some states. Originally, regulators thought that the acetaminophen discourages people from misusing Fioricet because too much acetaminophen can cause harm, such as liver damage. So the regulators let each state decide how to classify Fioricet. But recent data shows that having acetaminophen in Fioricet might not be enough to stop people from misusing the medication. So there's a possibility that state laws might change in the future and Fioricet might be classified as a controlled substance in all states, just like Fiorinal.
Fiorinal contains butalbital, aspirin, and caffeine. It takes about a week for butalbital and about 15 hours for both aspirin and caffeine to leave your body after a single dose. This time frame is estimated based on the half-life for each ingredient in Fiorinal. But this can differ from person to person based on factors such as age, liver health, and kidney health. Talk with your healthcare team if you have specific concerns about how long Fiorinal might stay in your body.
No, don't take Fiorinal with ibuprofen (Advil) or other non-steroidal anti-inflammatory drug (NSAIDs). Each Fiorinal pill contains 325 mg of aspirin. Taking multiple NSAIDs together, such as ibuprofen (Advil) and aspirin, raises your risk for side effects, serious heart problems, kidney problems, and stomach bleeding and ulcers. Instead of ibuprofen (Advil), you can take acetaminophen (Tylenol) if you need additional pain relief. But keep in mind that acetaminophen might not be the best choice for people with liver problems; when the liver can't break down acetaminophen well, it can lead to toxic buildup in the body. To be safe, ask a pharmacist for suggestions about safe pain medications to use with Fiorinal.
You can take Fiorinal as often as every 4 hours, up to 6 pills per day, to relieve pain for tension headaches. But your healthcare professional might prescribe a different dose for you. It's important to follow your prescriber's exact instructions so the medication is as safe as possible for you. Taking higher doses of Fiorinal or taking it for a long period of time can cause dependence. This can also lead to rebound headaches or medication-overuse headaches — when headaches come back as a result of taking too much medication. In general, avoid taking Fiorinal for more than 10 days in a month or for more than 3 months. Talk to your prescriber about other options to relieve your headaches.
In general, it isn't recommended to take Fiorinal if you're pregnant. The FDA recommends avoiding medications containing aspirin at doses of 325 mg or greater, such as Fiorinal, at 20 weeks or later of pregnancy. There's a potential risk for kidney and heart problems in your unborn baby and complications like low amniotic fluid. Talk to your obstetrician-gyncelogist (OB-GYN) about safer options to treat your headaches during pregnancy.
Taking Fiorinal generally isn't recommended if you're breastfeeding. Fiorinal contains butalbital. Butalbital can get into breast milk, and there have been reports of poor feeding and vomiting in breastfed babies. Talk to your prescriber about safer options to treat your headaches while you're breastfeeding.
The brand-name product, Fiorinal, has been discontinued and is no longer available. But there are generic versions of the medication still available on the market.
