uses
What is butalbital/acetaminophen/caffeine/codeine used for?Butalbital/acetaminophen/caffeine/codeine is commonly used to help relieve tension headaches, which can be caused by tight or tense muscles.Butalbital/acetaminophen/caffeine/codeine may also be used for other conditions as determined by your health care provider.How does butalbital/acetaminophen/caffeine/codeine work (mechanism of action)?Butalbital, acetaminophen, caffeine, and codeine work in different ways to relieve a tension headache. Butalbital is a barbiturate that works by slowing down your brain and nervous system. Acetaminophen blocks pain signals. Caffeine decreases the size of blood vessels in the head, which reduces excess blood flow. Codeine attaches to specific receptors in the body to reduce the feeling of pain.How is butalbital/acetaminophen/caffeine/codeine supplied (dosage forms)?Brand and other namesFioricet with codeineDosage forms and strengths50 mg/300 mg/40 mg/30 mg oral capsules50 mg/325 mg/40 mg/30 mg oral capsulesHow should I store butalbital/acetaminophen/caffeine/codeine?Butalbital/acetaminophen/caffeine/codeine should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.Â
how to use
capsule that is swallowed
drug interactions
Does butalbital/acetaminophen/caffeine/codeine interact with foods or drinks?Limit eating or drinking grapefruit or grapefruit juice. Grapefruit can increase your risk of side effects from butalbital/acetaminophen/caffeine/codeine. Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Drinking alcohol while taking butalbital/acetaminophen/caffeine/codeine can increase your risk of overdose and death.Does butalbital/acetaminophen/caffeine/codeine interact with other medicines (drug interactions)?Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.In particular, make sure that you discuss if you are using any of the following before taking butalbital/acetaminophen/caffeine/codeine.A monoamine oxidase inhibitor (MAOI) within the past two weeks, which is a medicine usually used for depression or Parkinson’s diseaseAn opioid, such as codeine, fentanyl, morphine, or oxycodone, which is a medicine used for certain types of painA mixed agonist/antagonist or partial agonist opioid analgesic, such as buprenorphine (Butrans, Sublocade), butorphanol, and others, which is used to treat certain types of pain or opioid use disorderMirtazapine (Remeron, Remeron Soltab), a tricyclic antidepressant, a selective serotonin reuptake inhibitor (SSRI), or a serotonin and norepinephrine reuptake inhibitor (SNRI), which are commonly used for anxiety and depressionA benzodiazepine, such as clonazepam (Klonopin), diazepam (Valium and others), or lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizuresA triptan, such as eletriptan (Relpax), sumatriptan (Imitrex and others), and others, which is a medicine commonly used to treat migraineAn antipsychotic, which is a medicine for certain mental health conditionsA macrolide antibiotic, such as clarithromycin or erythromycin (Ery-Tab and others), which is a medicine used for bacterial infectionsFluconazole (Diflucan), itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which are used for fungal infectionsA protease inhibitor, such as nelfinavir (Viracept) or ritonavir (Norvir),which is a medicine commonly used to treat HIVRifampin, which is a medicine commonly used to treat an infection called tuberculosisCarbamazepine (Carbatrol, Tegretol, and others) or phenytoin (Dilantin, Phenytek, and others), which are commonly used to treat seizuresA diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressureAny medicine that affects serotonin in your body, such as medicines for depression, anxiety, or certain mental health conditions, some migraine medicines, and some medicines for nausea and vomiting. An anticholinergic medicine, which includes antihistamines and medicines commonly used for overactive bladder, Parkinson’s disease, or stomach problemsAny other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, muscle relaxants, and medicines for anxietyMany other medicines may alter the blood levels of butalbital/acetaminophen/caffeine/codeine. Tell your health care provider about all medicines that you take or have recently taken.This may not be a complete list of medicines that can interact with butalbital/acetaminophen/caffeine/codeine. Always check with your health care provider.
side effects
What are the most common side effects of butalbital/acetaminophen/caffeine/codeine?The most common side effects of butalbital/acetaminophen/caffeine/codeine are listed below. Tell your health care provider if you have any of these side effects that bother you.Drowsiness or tirednessDizziness or lightheadednessShortness of breathNausea, vomiting, or constipationStomach painIntoxicated feelingThere may be other side effects of butalbital/acetaminophen/caffeine/codeine that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.What are the serious side effects of butalbital/acetaminophen/caffeine/codeine?While less common, the most serious side effects of butalbital/acetaminophen/caffeine/codeine are described below, along with what to do if they happen.Severe Allergic Reactions. Butalbital/acetaminophen/caffeine/codeine may cause allergic reactions, which can be serious. Stop taking butalbital/acetaminophen/caffeine/codeine and get help right away if you have any of the following symptoms of a serious allergic reaction.Breathing problems or wheezingRacing heartFever or general ill feelingSwollen lymph nodesSwelling of the face, lips, mouth, tongue, or throatTrouble swallowing or throat tightnessItching, skin rash, or pale red bumps on the skin called hivesNausea or vomitingDizziness, feeling lightheaded, or faintingStomach crampsJoint painRisk of Misuse and Addiction. Misusing butalbital/acetaminophen/caffeine/codeine can lead to serious side effects like coma or death. Misuse means taking a medicine in a way other than how it was prescribed. Take butalbital/acetaminophen/caffeine/codeine exactly as prescribed. Tell your health care provider if you feel that butalbital/acetaminophen/caffeine/codeine is not working. Call your health care provider right away or go to the nearest emergency room if you have any of the following serious symptoms.Sudden confusion or feeling disorientedFeeling paranoidSuicidal thoughts or actionsSeizuresTrouble breathingBreathing Problems. Butalbital/acetaminophen/caffeine/codeine may cause slow or shallow breathing, especially if you have breathing problems from another condition or take other medicines that can slow your breathing. Tell your health care provider if you develop severe sleepiness or trouble breathing, especially when you start butalbital/acetaminophen/caffeine/codeine or when your dose is increased. Get emergency help if you have any of the following symptoms.Changes in the color of your skin, including bluish color to your lips and fingernailsConfusionShortness of breathFeeling dizzy, lightheaded, or faintingChanges in your heart rate or rhythm, such as a fast, slow, pounding or skipping heartbeat Slow or shallow breathingExcessive sleepiness or trouble staying awakeLiver Damage. Liver damage, also called hepatotoxicity, can happen when taking butalbital/acetaminophen/caffeine/codeine. Call your health care provider right away if you have any of the following symptoms of liver damage.Nausea or vomitingStomach or belly painFeverWeakness or unusual tirednessItchingLoss of appetiteLight-colored poopDark-colored urine (pee)Your skin or the whites of your eyes turning yellowish in color (also called jaundice)Increased Pain Sensitivity (Hyperalgesia). Butalbital/acetaminophen/caffeine/codeine can cause an increased sensitivity to pain, making pain feel more painful than usual. Butalbital/acetaminophen/caffeine/codeine can also cause allodynia. This happens when things that normally do not cause pain, such as wearing glasses or brushing your hair, become painful. If your pain increases, do not take extra doses of butalbital/aspirin/caffeine/codeine. This could cause you to overdose or develop other serious side effects. Call your health care provider right away if your pain increases, you feel more sensitive to pain, or if you develop pain in other areas of the body. Reduced Adrenal Function. Long-term use of butalbital/acetaminophen/caffeine/codeine can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency. Adrenal insufficiency can get worse if your body is under stress because of fever, surgery, or trauma. Tell your health care provider if you have any of the following symptoms of adrenal insufficiency.Nausea and vomitingWeakness, tiredness, or lack of energyLow blood pressureLow Blood Pressure (Hypotension). Butalbital/acetaminophen/caffeine/codeine may cause low blood pressure. If you feel faint or dizzy, lie down. Tell your health care provider right away if you have any of the following symptoms of low blood pressure.Dizziness, feeling lightheaded, or faintingConfusionFeeling weak or tiredSeizures. Some people who have taken butalbital/acetaminophen/caffeine/codeine have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Stop taking butalbital/acetaminophen/caffeine/codeine and call your health care provider if you have any of the following signs that a seizure is happening or could happen.Muscle twitching, jerking, spasms, tremors, or other uncontrolled movementsStiffening of your arms and legsFeeling anxious, nervous, confused, or a sense of dreadFeeling dizzy or lightheadedFalling or losing consciousnessSphincter of Oddi Spasm. The sphincter of Oddi is a muscular valve in your body that controls the flow of bile and digestive juices from the pancreas into the small intestine. When this valve spasms, it may feel like getting a tight muscle cramp, causing pain and blocking the flow of these juices, which can lead to discomfort and digestive problems. This is more likely to happen if you do not have a gallbladder. Stop taking butalbital/acetaminophen/caffeine/codeine and get emergency medical help if you have new or worse stomach pain or pain in the upper right side of your stomach-area that travels to your back or shoulder, with or without nausea and vomiting. Severe Skin Reactions. Butalbital/acetaminophen/caffeine/codeine can cause severe skin reactions called acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can lead to death if not treated. If you develop a rash, stop butalbital/acetaminophen/caffeine/codeine and call your health care provider right away. Get emergency help if you have any of the following symptoms of a severe skin reaction.Painful red or purple skin that looks burned and peels offFlat red rash or blisters on your skin, mouth, nose, and genitalsRed, painful, watery eyes
overdose and misseddose
What should I do if I accidentally use too much butalbital/acetaminophen/caffeine/codeine?If you or someone else has used too much butalbital/acetaminophen/caffeine/codeine, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.What should I do if I miss a dose of butalbital/acetaminophen/caffeine/codeine?If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. Do not take more than your prescribed dose.
warnings and Precautions
Who should not use butalbital/acetaminophen/caffeine/codeine?Allergies to Ingredients. People who are allergic to any of the following should not take butalbital/acetaminophen/caffeine/codeine.AcetaminophenButalbitalCaffeineCodeineFioricet with codeineAny of the ingredients in the specific product dispensedYour pharmacist can tell you all of the ingredients in the specific butalbital/acetaminophen/caffeine/codeine products they stock.Porphyria. Butalbital/acetaminophen/caffeine/codeine should not be used if you have porphyria, which is a rare disorder that affects the body’s ability to make a substance called heme. Heme is important for carrying oxygen in the blood. When the body can not make heme properly, certain chemicals build up and cause nerve or skin problems.Drug Interactions. Butalbital/acetaminophen/caffeine/codeine should not be taken while you are using certain other medicines. Before taking butalbital/acetaminophen/caffeine/codeine, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using or have used recently. See the Interactions section for more details.Children. Butalbital/acetaminophen/caffeine/codeine should not be used in any child younger than 12 years of age or in a child younger than 18 years of age after a surgery to remove their tonsils or adenoids (tonsillectomy and/or adenoidectomy). Slow or shallow breathing that can lead to death may occur. Gut Blockage. Butalbital/acetaminophen/caffeine/codeine should not be taken if you have a blockage of your gut (bowel obstruction) or a narrowing of the stomach or intestines. This medicine can make these conditions worse. Slowed Gut Movement. Paralytic ileus is a type of ileus where your intestines are unable to move food through them. Butalbital/acetaminophen/caffeine/codeine can make this condition worse.Lung problems. Butalbital/acetaminophen/caffeine/codeine should not be used if you have severe asthma, trouble breathing, or other lung problems. Butalbital/acetaminophen/caffeine/codeine can make these conditions worse.What should I know about butalbital/acetaminophen/caffeine/codeine before using it?Do not take butalbital/acetaminophen/caffeine/codeine unless it has been prescribed to you by a health care provider. Take it as prescribed.Do not share butalbital/acetaminophen/caffeine/codeine with other people, even if they have the same condition as you. It may harm them.Keep butalbital/acetaminophen/caffeine/codeine out of the reach of children. Butalbital/acetaminophen/caffeine/codeine is a controlled substance because it can be misused or lead to dependence. Store this medicine in a safe place to protect it from theft. It is illegal to sell or give away this medicine.If you have been taking butalbital/acetaminophen/caffeine/codeine on a regular basis, do not stop taking the medicine without talking to your health care provider. Stopping too quickly can cause serious side effects. Call your health care provider right away if you have any of the following symptoms.Feeling restlessWatery eyes or runny noseYawningSweating or chillsMuscle, joint, or back painDilated pupils Irritability, anxiety, or trouble sleepingNausea, vomiting, diarrhea, or loss of appetiteIncrease in blood pressure, breathing rate, or heart rateButalbital/acetaminophen/caffeine/codeine can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how this medicine affects you.Do not take more than 4,000 mg of acetaminophen per day. Taking too much acetaminophen can cause serious liver problems that could lead to death. Talk to your pharmacist about which medicines contain acetaminophen. It can be found in Tylenol, some cough and cold medicines, some sleep medicines, and others. If you take too much acetaminophen, get emergency help right away, even if you do not feel sick.People who are 65 and older can be at greater risk for some side effects from butalbital/acetaminophen/caffeine/codeine. Talk to your health care provider about your risks if you are in this age group.Dispose of expired, unwanted, or unused butalbital/acetaminophen/caffeine/codeine right away by taking your medicine to an authorized DEA-registered collector or drug take back program. If one is not available, you can mix medicine with dirt, coffee grounds, or cat litter, then place the mixture in a sealed plastic bag and throw the bag in the trash. Some butalbital/acetaminophen/caffeine/codeine products may contain an ingredient called FD&C Yellow No. 5, also called tartrazine. If you have an allergy to aspirin, you may be more likely to have a tartrazine allergy.Long-term use of butalbital/acetaminophen/caffeine/codeine may affect your ability to become pregnant or get a partner pregnant. Talk with your health care provider if you have any concerns.Your health care provider may ask you to have naloxone, a medicine used to reverse the effects of codeine, on hand in case of an emergency. Make sure that you and a caregiver know how to use naloxone. If you have any questions, talk to your health care provider or pharmacist. What should I tell my health care provider before using butalbital/acetaminophen/caffeine/codeine?Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if butalbital/acetaminophen/caffeine/codeine is right for you.In particular, make sure that you discuss any of the following.Alcohol Use Disorder or Substance Use Disorder. Talk to your health care provider if you use or used to use street drugs or have or had a problem using alcohol or prescription medicines or live with someone with this problem. Current and Past Health Conditions. Tell your health care provider if you have any of the following. Brain tumor or head injurySeizuresLiver, kidney, or thyroid problemsStomach, pancreas, or gallbladder problemsBreathing problems, such as asthma or chronic obstructive pulmonary disease (COPD)Obstructive sleep apneaProblems peeing DiabetesOpioid overdoseMental health problemsRecent or upcoming surgery to remove your tonsils or adenoidsAny genetic conditions that affect how your body metabolizes medicinesPregnancy. Butalbital/acetaminophen/caffeine/codeine may cause harm to an unborn baby. Tell your health care provider if you are or plan to become pregnant. If you take this medicine on a regular basis during pregnancy, your baby may have withdrawal symptoms. Tell your health care provider if you took butalbital/acetaminophen/caffeine/codeine during your pregnancy, especially near the end of your pregnancy.Breastfeeding. Do not take butalbital/acetaminophen/caffeine/codeine while you are breastfeeding. Butalbital/acetaminophen/caffeine/codeine can pass into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.
about
Butalbital/acetaminophen/caffeine/codeine is used for tension headaches. It slows down your nervous system, blocks pain signals, and reduces excess blood flow to help with tension headaches. Common side effects include dizziness and drowsiness. Do not drive or do other activities that require alertness or coordination until you know how this medicine affects you.