Butalbital acetaminophen side effects

Fioricet

SIDE EFFECTS

Frequently Observed

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed

All adverse events tabulated below are classified as infrequent.

Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Autonomic Nervous System: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.

The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dos age are listed in the OVERDOSAGE section.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

Drug Abuse And Dependence

Abuse And Dependee

Butalbital

Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

Read the entire FDA prescribing information for Fioricet (Butalbital and Acetaminophen Tablets)

What Are the Dangers of Butalbital Addiction?

Like all barbiturates, butalbital has a high potential for abuse and for the development of physical dependence. Tolerance to barbiturates like butalbital develops very quickly in individuals who abuse the drug. When tolerance occurs, users will attempt to take higher doses more frequently in an effort to achieve the same results they used to get at lower doses. Some signs that someone is abusing or addicted to butalbital include:

  • The person obtains the drug without a prescription, or if they have a prescription, they use the drug more often or in higher doses than specified by the prescription.
  • Individuals with prescriptions who engage in doctor shopping to obtain more drugs are most likely abusing the drug.
  • People who spend significant amounts of time trying to obtain the drug, using the drug, or recovering from use of the drug are most likely abusing the drug.
  • Using butalbital in ways not typically prescribed, such as grinding it up into powder and snorting it, or mixing it with other drugs.
  • Individuals who abuse barbiturates like butalbital will often appear drowsy or lethargic or may even appear intoxicated and present with slurred speech, issues with coordination, and decreased mental and physical reaction times.
  • People who abuse barbiturates often begin spending significant periods of time alone or with other individuals who are known substance abusers.
  • Users may get very defensive or even angry when someone attempts to discuss their use of drugs with them.
  • Individuals who abuse barbiturates will often begin to demonstrate issues with attention and with memory.
  • Users may display intermittent periods of irritability, restlessness, sensitivity, and/or complaining of feeling sick or having flulike symptoms as a result of the initial withdrawal process associated with not using butalbital.
  • Anyone who continues to use butalbital despite experiencing obvious negative issues associated with their drug use, such as issues with work, school, or in their relationships with others, is most likely abusing the drug.

Withdrawal from Butalbital

As mentioned, butalbital is a drug that carries a significant risk for the development of physical dependence. Individuals who have been taking or abusing butalbital for significant periods of time (typically regular use or abuse for a period of 4-6 weeks or longer) will almost assuredly develop some withdrawal symptoms. The longer the person used the drug, the more severe the symptoms will be. The withdrawal process from butalbital can initially be quite discomforting.

A general timeline for withdrawal is:

  • An acute phase that can begin hours or up to 2-3 days following discontinuation, depending on the level of abuse/use the person was involved in. In the acute phase, potential symptoms include one or more of a long list of symptoms that can include fever, increased blood pressure, increased heart rate, increased rates of breathing, nausea, vomiting, tremors (particularly in the hands), ringing in the ears, severe fatigue, marked disorientation (delirium), confusion, anxiety, severe headache, hallucinations, and/or seizures. Obviously, individuals will begin experiencing cravings in order to reduce the intensity of the withdrawal symptoms. Individuals who become extremely confused or disoriented, or who experience hallucinations or seizures, are in need of immediate medical treatment, as the development of seizures can lead to fatal complications.
  • The acute withdrawal phase can last up to seven days. Following that phase, the symptoms will become significantly less intense, but individuals may still have issues with anxiety, irritability, nausea, fever or chills, and other feelings of being ill. The symptoms can last for several weeks. Cravings may continue.
  • Longer-term issues may persist, such as depression, anxiety, sensitivity to perceived stress, issues with motivation, and an occasional desire to return to using the drug.

Because the withdrawal symptoms from butalbital can be potentially severe, it is highly recommended that anyone who has used the drug for any length of time consult a physician before discontinuing its use. Individuals engaging in medically assisted withdrawal programs, where physicians monitor the withdrawal process, administer drugs to counteract severe symptoms, and taper down the dosages of the drugs to allow the individual to slowly adjust and detox, are safer and experience higher success rates than people who simply wish to stop using drugs on their own.

In addition, individuals with substance use disorders are encouraged to seek out long-term treatment to address the issues that contributed to their substance abuse and to develop a plan to cope without drugs, learn positive coping skills, and avoid relapse in the future. Because relapse rates for individuals who have had substance use disorders are very high, it is important to maintain a long-term treatment strategy.

Acetaminophen, butalbital, and caffeine

Medically reviewed by Drugs.com on Jan 15, 2020 – Written by Cerner Multum

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What is acetaminophen, butalbital, and caffeine?

Acetaminophen is a pain reliever and fever reducer.

Butalbital is in a group of drugs called barbiturates. 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.

Acetaminophen, butalbital, and caffeine is a combination medicine used to treat tension headaches that are caused by muscle contractions.

Acetaminophen, butalbital, and caffeine may also be used for purposes not listed in this medication guide.

Important Information

You should not use acetaminophen, butalbital, and caffeine if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin 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.

Before taking this medicine

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use acetaminophen, butalbital, and caffeine if you are allergic to it, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

To make sure acetaminophen, butalbital, and caffeine is safe for you, tell your doctor if you have:

  • liver disease, cirrhosis, a history of alcoholism or drug addiction, or if you drink more than 3 alcoholic beverages per day;

  • kidney disease;

  • asthma, sleep apnea, or other breathing disorder;

  • stomach ulcer or bleeding;

  • a history of skin rash caused by any medication;

  • a history of mental illness or suicidal thoughts; or

  • if you use medicine to prevent blood clots.

It is not known whether this medicine 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. Tell your doctor if you are pregnant or plan to become pregnant.

This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take acetaminophen, butalbital, and caffeine?

Follow all directions on your prescription label. Do not take more of this medication than recommended. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Butalbital may be habit-forming. Never share acetaminophen, butalbital, and caffeine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take the medicine with food or milk if it upsets your stomach.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

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 acetaminophen, butalbital, and caffeine can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.

What should I avoid while taking acetaminophen, butalbital, and caffeine?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice.

Acetaminophen, butalbital, and caffeine side effects

Get emergency medical help if you have signs of an allergic reaction: 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 acetaminophen, butalbital, and caffeine 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 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.

Acetaminophen, butalbital, and caffeine dosing information

Usual Adult Dose for Headache:

Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day
Butalbital 50 mg/acetaminophen 325 mg/caffeine 40 mg: 1 or 2 capsules or tablets orally every 4 hours as needed not to exceed 6 capsules or tablets per day
Butalbital 50 mg/acetaminophen 325 mg/caffeine per 15 mL oral liquid: 15 to 30 mL orally every 4 hours as needed not to exceed 90 mL per day

-Due to high rate of physical dependence, the extended use of this drug is not recommended.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.
Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Usual Pediatric Dose for Headache:

12 years or older:
Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day
Butalbital 50 mg/acetaminophen 325 mg/caffeine 40 mg: 1 or 2 capsules or tablets orally every 4 hours as needed not to exceed 6 capsules or tablets per day
Butalbital 50 mg/acetaminophen 325 mg/caffeine per 15 mL oral liquid: 15 to 30 mL orally every 4 hours as needed not to exceed 90 mL per day

-Due to high rate of physical dependence, the extended use of this drug is not recommended.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.
Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

What other drugs will affect acetaminophen, butalbital, and caffeine?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking acetaminophen, butalbital, and caffeine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with acetaminophen, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 6.02.

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  • Headache

Butalbital is one of the most important active ingredients in Fioricet, and it’s also the most addictive. Butalbital, as mentioned above, is a barbiturate that helps to relax muscle contractions that can contribute to headaches.

Barbiturates are a class of drugs that were first introduced in the late 19th century, and by the 60s and 70s barbiturate abuse had become a big problem. The use of barbiturates has declined since then as safer options have come up, but they are still in use in some drugs including Fioricet.

Barbiturates like butalbital can be physically and psychologically addictive, and the risk of overdose is high with these drugs because there’s minimal distinction between a dose that could be considered safe and one that could be deadly. For the most part with the exception of drugs like Fioricet, the use of medications with barbiturates has been replaced by benzodiazepines like Valium.

A few things to know include the fact that there is no antidote to reverse barbiturate poisoning, and you can become physically dependent on this class of drugs which means you would experience withdrawal symptoms after suddenly stopping use.

In general, barbiturates have a calming effect that’s similar in many ways to alcohol. Along with the treatment of migraines, barbiturates may be used for the treatment of seizure disorder or as an anesthetic.

Barbiturates aren’t necessarily a big problem on the black market, as that’s more dominated by opioids, and the use of these drugs can be so dangerous that it’s less abused than others.

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24 Feb Reader’s Mail: Side Effects for Cutting Back on Fioricet?

Posted at 18:05h in News to Know, Reader’s Mail by headache

Q. I have been on Fioricet for 2 years. I had been taking 6 tablets a day. My physician recommended that I cut back, due to rebound headache, every 4 days. I have now cut back to 3 tablets, and I’m experiencing extreme drowsiness and agitation. I was told it’s not a side effect. Do you have any recommendations for alternative medication(s) that I can try? Also, I would like to know if you’ve ever heard of anyone else experiencing these types of side effects.

A. Butalbital-containing medications such as Fioricet (butalbital/acetaminophen/caffeine) and Fiorinal (butalbital/aspirin/caffeine) have long been implicated in the development of rebound (medication overuse) headaches. One of the problems with Fioricet is that it has a long half-life of about 36 hours, which means that it takes 1.5 days for the body to eliminate half of the dose of the drug. It takes between 5 to 6 half-lives for the drug to reach a steady state, and you can still see traces of the drug in the blood and urine for more than 10 days after taking Fioricet or Fiorinal. There is an increased risk of tolerance and habituation to the drug when taking multiple doses daily. Weaning off the drug is usually done slowly since there is a risk of seizures and/or delirium. The severity of withdrawal symptoms is directly related to the amount of the medication taken and can include anxiety, weakness, nausea, vomiting, weight loss, involuntary muscle twitching, fatigue, decreased blood pressure, and dizziness. Withdrawal symptoms can be seen within 8 to 36 hours after the last dose is taken. A recent recommendation from the American Academy of Neurology has stated, “Don’t use opioid or butalbital treatment for migraine except as a last resort.” (Langer -Gould AM, Anderson WE, Armstrong MJ, et al. The American Academy of Neurology’s TOP Five Choosing Wisely recommendations. Neurology. 2013;81:1004-1011.)

Regarding alternatives in the treatment of migraine, the most important is the use of daily preventive medication(s) for long-term migraine control. This can include a single daily preventive medication or a combination of medications. Commonly prescribed daily preventive medications include beta blockers, antiepileptic medications, or tricyclic antidepressants. OnabotulinumtoxinA (Botox) is FDA-approved for the prevention of chronic migraine and can be an effective option in some patients. Last year, the FDA approved a device, Cefaly, which delivers microimpulses in order to stimulate nerve endings in the trigeminal nerve and may help to decrease migraine frequency. Treatment of migraine with acute medications such as triptans, ergotamine, or anti-inflammatory agents should be limited to no more than 2 to 3 days per week in order to prevent the development of rebound headache.

George R. Nissan, D.O.

Baylor Comprehensive Headache Center

Dallas, Texas

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