Medical Editor: John P. Cunha, DO, FACOEP
Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) is a combination of a pain reliever/anti-inflammatory/fever reducer, a barbiturate, a vasoconstrictor, and a narcotic pain reliever (opiate-type) used to relieve complex tension headaches. Fiorinal with Codeine is available in generic form. Common side effects of Fiorinal with Codeine include nausea, vomiting, stomach upset, heartburn, gas, constipation, diarrhea, shaking (tremor), lightheadedness, dizziness, anxiety, agitation, drowsiness, mood changes, sleep problems (insomnia), sweating, urinating more than usual, ringing in your ears, blurred vision, or dry mouth.
Dose of Fiorinal with Codeine is 1 or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules. Fiorinal with Codeine may interact with monoamine oxidase inhibitors (MAOIs), antidepressants, alcohol, antihistamines, sedatives, pain relievers, anxiety medicines, muscle relaxants, anticoagulants, probenecid or sulfinpyrazone, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin and other salicylates (forms of aspirin), steroids, or insulin and oral anti-diabetic drugs. Tell your doctor all medications you are taking. Fiorinal with Codeine is not recommended for use during pregnancy. This drug passes into breast milk and could have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug. Butalbital and codeine are both habit-forming and potentially abusable. Withdrawal symptoms may occur when you stop taking this medication.
Our Fiorinal with Codeine (butalbital, aspirin, 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.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult 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, muscle twitching;
- confusion, unusual thoughts or behavior;
- bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- problems with urination; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects include:
- feeling dizzy, shaky, anxious, or agitated;
- heartburn, mild nausea, vomiting, upset stomach, constipation, diarrhea;
- mood changes, sleep problems (insomnia);
- sweating, urinating more than usual; or
- ringing in your ears, blurred vision, or dry mouth.
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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Fiorinal with Codeine (Butalbital Compound With Codeine)
The most commonly reported adverse events associated with the use of Fiorinal with Codeine and not reported at an equivalent incidence by placebo-treated patients were nausea and/or abdominal pain, drowsiness, and dizziness.
Associated with Treatment Discontinuation
Of the 382 patients treated with Fiorinal with Codeine in controlled clinical trials, three (0.8%) discontinued treatment with Fiorinal with Codeine because of adverse events. One patient each discontinued treatment for the following reasons: gastrointestinal upset; lightheadedness and heavy eyelids; and drowsiness and generalized tingling.
Incidence in Controlled Clinical Trials
The following table summarizes the incidence rates of the adverse events reported by at least 1% of the Fiorinal with Codeine treated patients in controlled clinical trials comparing Fiorinal with Codeine to placebo, and provides a comparison to the incidence rates reported by the placebo-treated patients.
The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators.
Adverse Events Reported by at Least 1% of Fiorinal with Codeine Treated Patients During Placebo Controlled Clinical Trials
Incidence Rate of Adverse
|Body System/ Adverse Event||Fiorinal with Codeine
(N = 382)
(N = 377)
Other Adverse Events Reported During Controlled Clinical Trials
The listing that follows represents the proportion of the 382 patients exposed to Fiorinal with Codeine while participating in the controlled clinical trials who reported, on at least one occasion, an adverse event of the type cited. All reported adverse events, except those already presented in the previous table, are included. It is important to emphasize that, although the adverse events reported did occur while the patient was receiving Fiorinal with Codeine, the adverse events were not necessarily caused by Fiorinal with Codeine.
Adverse events are classified by body system and frequency. “Frequent” is defined as an adverse event which occurred in at least 1/100 (1%) of the patients; all adverse events listed in the previous table are frequent. “Infrequent” is defined as an adverse event that occurred in less than 1/100 patients but at least 1/1000 patients. 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, and sluggishness.
Autonomic Nervous: dry mouth and hyperhidrosis.
Gastrointestinal: vomiting, difficulty swallowing, and heartburn.
Musculoskeletal: leg pain and muscle fatigue.
Voluntary reports of adverse drug events, temporally associated with Fiorinal with Codeine, that have been received since market introduction and that were not reported in clinical trials by the patients treated with Fiorinal with Codeine, are listed below. Many or most of these events may have no causal relationship with the drug and are listed according to body system.
Central Nervous: abuse, addiction, anxiety, depression, disorientation, hallucination, hyperactivity, insomnia, libido decrease, nervousness, neuropathy, psychosis, sedation, sexual activity increase, slurred speech, twitching, unconsciousness, vertigo.
Urinary: kidney impairment, urinary difficulty.
The following adverse drug events may be borne in mind as potential effects of the components of Fiorinal with Codeine. Potential effects of high dosage are listed in the OVERDOSAGE section of this insert.
Aspirin: occult blood loss, hemolytic anemia, iron deficiency anemia, gastric distress, heartburn, nausea, peptic ulcer, prolonged bleeding time, acute airway obstruction, renal toxicity when taken in high doses for prolonged periods, impaired urate excretion, hepatitis.
Codeine: nausea, vomiting, drowsiness, lightheadedness, constipation, pruritus.
Drug Abuse And Dependence
Fiorinal with Codeine is controlled by the Drug Enforcement Administration and is classified under Schedule III.
Abuse and Dependence
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.
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.
Read the entire FDA prescribing information for Fiorinal with Codeine (Butalbital Compound With Codeine)
© Fiorinal with Codeine Patient Information is supplied by Cerner Multum, Inc. and Fiorinal with Codeine Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.