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Fiorinal with Codeine

Last reviewed on RxList: 10/1/2018
Fiorinal with Codeine Side Effects Center

Last reviewed on RxList 10/1/2018

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.

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Fiorinal with Codeine Consumer Information

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
  • a slow heart rate or weak pulse;
  • a light-headed feeling, like you might pass out;
  • confusion, unusual thoughts or behavior;
  • easy bruising or bleeding (nosebleeds, bleeding gums);
  • severe constipation;
  • symptoms of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women.

Common side effects include:

  • nausea, vomiting, stomach pain, constipation;
  • headache, dizziness, drowsiness; or
  • feeling tired.

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 Fiorinal with Codeine (Butalbital Compound With Codeine)

QUESTION

Who suffers more frequently from migraine headaches? See Answer
Fiorinal with Codeine Professional Information

SIDE EFFECTS

The following serious adverse reactions are described, or described in greater detail, in other sections:

  • Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
  • Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
  • Interactions with Benzodiazepines or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
  • Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see WARNINGS AND PRECAUTIONS]
  • Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
  • Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
  • Severe Hypotension [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Withdrawal [see WARNINGS AND PRECAUTIONS]
  • Coagulation Abnormalities and Bleeding [see WARNINGS AND PRECAUTIONS]
  • Reye's Syndrome [see WARNINGS AND PRECAUTIONS]
  • Allergy [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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 Events

Body System/Adverse Event FIORINAL with CODEINE
(N=382)
Placebo
(N =377)
Central Nervous
Drowsiness 2.4% 0.5%
Dizziness/Lightheadedness 2.6% 0.5%
Intoxicated Feeling 1.0% 0%
Gastrointestinal
Nausea/Abdominal Pain 3.7% 0.8%

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.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain and muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, and tinnitus.

The following adverse drug reactions have been reported with the components of FIORINAL with CODEINE. Potential effects of high dosage are listed in the [see 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.

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

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

Postmarketing Experience

The following adverse reactions have been identified during post approval use of FIORINAL with CODEINE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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

Autonomic Nervous: epistaxis, flushing, miosis, salivation.

Gastrointestinal: anorexia, appetite increased, constipation, diarrhea, esophagitis, gastroenteritis, gastrointestinal spasm, 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.

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in FIORINAL with CODEINE.

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Fiorinal with Codeine (Butalbital Compound With Codeine)

Related Resources for Fiorinal 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.

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