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Fioricet with Codeine

Last reviewed on RxList: 4/4/2016
Fioricet with Codeine Side Effects Center

Last reviewed on RxList 11/22/2016

Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) is a combination of a pain reliever and fever reducer, a barbiturate, a vasoconstrictor, and a narcotic pain reliever (opiate-type) used to relieve complex tension headaches. Fioricet with Codeine is available in generic form. Common side effects of Fioricet with Codeine include:

Tell your doctor if you have serious side effects of Fioricet with Codeine including:

  • mental/mood changes,
  • fast or irregular heartbeat,
  • increased thirst or urination,
  • signs of infection (e.g., fever, persistent sore throat),
  • easy bruising or bleeding, or
  • changes in the amount of urine.

Dose of Fioricet with Codeine is 1 or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules. Fioricet with Codeine may interact with other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), glycopyrrolate, mepenzolate, ciprofloxacin, atropine, benztropine, dimenhydrinate, methscopolamine, scopolamine, bladder or urinary medications, bronchodilators, irritable bowel medications, or MAO inhibitors. Tell your doctor all medications you are taking. During pregnancy, Fioricet with Codeine should be used only when prescribed. Using it near the expected delivery date is not recommended because of possible harm to the fetus. Infants born to mothers who have used this medication may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, seizures, or diarrhea. Tell your doctor if you notice symptoms in your newborn. This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breastfeeding. Butalbital and codeine are both habit-forming and potentially abusable. Withdrawal symptoms may occur when you stop taking this medication.

Our Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Fioricet with Codeine Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • shallow breathing, slow heart rate;
  • fast or pounding heart rate, feeling short of breath;
  • confusion, unusual thoughts or behavior, feeling light-headed, fainting;
  • muscle twitching;
  • easy bruising or bleeding; or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

  • feeling dizzy or drowsy, shaky or agitated;
  • mild nausea, vomiting, upset stomach, constipation, diarrhea;
  • increased appetite, mood changes, sleep problems (insomnia); or
  • dry mouth, sweating, urinating more than usual.

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.

Read the entire detailed patient monograph for Fioricet with Codeine (Butalbital Acetaminophen Caffeine Capsules)

Fioricet with Codeine Professional Information

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: 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: 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.

The following adverse reactions have been voluntarily reported as temporally associated with Fiorinal® with Codeine, a related product containing aspirin, butalbital, caffeine, and codeine phosphate.

Central Nervous: abuse, addiction, anxiety, disorientation, hallucination, hyperactivity, insomnia, libido decrease, nervousness, neuropathy, psychosis, sexual activity increase, slurred speech, twitching, unconsciousness, vertigo.

Autonomic Nervous: epistaxis, flushing, miosis, salivation.

Gastrointestinal: anorexia, appetite increased, diarrhea, esophagitis, gastroenteritis, gastrointestinal spasms, hiccup, mouth burning, pyloric ulcer.

Cardiovascular: chest pain, hypotensive reaction, palpitations, syncope.

Skin: erythema, erythema multiforme, exfoliative dermatitis, hives, rash, toxic epidermal necrolysis.

Urinary: kidney impairment, urinary difficulty.

Miscellaneous: allergic reaction, anaphylactic shock, cholangiocarcinoma, drug interaction with erythromycin (stomach upset), edema.

The following adverse drug events may be borne in mind as potential effects of the components of Fioricet with Codeine. Potential effects of high dosage are listed in the OVERDOSAGE section.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

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

Codeine: nausea, vomiting, drowsiness, lightheadedness, constipation, pruritus.

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported for Butalbital, Acetaminophen, and Caffeine Tablets, USP.

Drug Abuse And Dependence

Controlled Substance

Fioricet with Codeine is controlled by the Drug Enforcement Administration and is classified under Schedule III.

Abuse And Dependence

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 1,500 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 twofold. 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.

Codeine

Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

Read the entire FDA prescribing information for Fioricet with Codeine (Butalbital Acetaminophen Caffeine Capsules)

Related Resources for Fioricet with Codeine

Read the Fioricet with Codeine User Reviews »

© Fioricet with Codeine Patient Information is supplied by Cerner Multum, Inc. and Fioricet with Codeine Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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