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Fioricet with Codeine Side Effects

Generic Name: acetaminophen / butalbital / caffeine / codeine

Note: This document contains side effect information about acetaminophen / butalbital / caffeine / codeine. Some of the dosage forms listed on this page may not apply to the brand name Fioricet with Codeine.

For the Consumer

Applies to acetaminophen / butalbital / caffeine / codeine: oral capsule

Along with its needed effects, acetaminophen/butalbital/caffeine/codeine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acetaminophen/butalbital/caffeine/codeine:

Less Common

  • Confusion (mild)
  • mental depression
  • unusual excitement (mild)

Rare

  • Bleeding or crusting sores on the lips
  • chest pain
  • fever with or without chills
  • hive-like swellings on the eyelids, face, lips, or tongue
  • hives, itching, or skin rash
  • muscle cramps or pain
  • red, thickened, or scaly skin
  • seeing, hearing, or feeling things that are not there
  • seizures
  • sore throat
  • sores, ulcers, or white spots in the mouth
  • swollen or painful glands
  • tightness in the chest
  • troubled breathing

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen/butalbital/caffeine/codeine:

Symptoms of Overdose

  • Anxiety (severe)
  • cold and clammy skin
  • confusion (severe)
  • dizziness, lightheadedness, drowsiness, or weakness (severe)
  • excitement (severe)
  • increased sleepiness in babies (more than usual)
  • increased sweating
  • irritability (severe)
  • limpness (in babies)
  • nausea
  • restlessness (severe)
  • slow, fast, or irregular heartbeat
  • slurred speech
  • stomach cramps or pain
  • swelling, pain, or tenderness in the upper abdomen or stomach area
  • trembling or shaking of the hands or feet
  • trouble sleeping (severe)
  • unusually slow or troubled breathing
  • vomiting

Some side effects of acetaminophen / butalbital / caffeine / codeine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Bloated or "gassy" feeling
  • dizziness or lightheadedness (mild)
  • drowsiness (mild)

For Healthcare Professionals

Applies to acetaminophen / butalbital / caffeine / codeine: oral capsule

General

The most frequently reported adverse events have included drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.[Ref]

Hepatic

Acetaminophen:

Frequency not reported: Liver failure[Ref]

Acute liver failure has been reported with acetaminophen use; many cases have been associated with use at doses in excess of 4 g/day, and often involving more than 1 acetaminophen-containing product.[Ref]

Respiratory

Common (1% to 10%): Shortness of breath

Uncommon (0.1% to 1%): Nasal congestion

Codeine:

Postmarketing reports: Respiratory depression including deaths[Ref]

Respiratory depression resulting in death has been reported in children who received codeine postoperatively following tonsillectomy and/or adenoidectomy. These children had evidence of being ultra-rapid metabolizers of codeine. Death has also been reported in nursing infants exposed to high levels of morphine in breast milk due to their breastfeeding mother being an ultra-rapid metabolizer of codeine.[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions

Postmarketing reports: Anaphylaxis

Acetaminophen:

Postmarketing reports: Anaphylaxis[Ref]

Dermatologic

Several cases of dermatologic reactions including toxic epidermal necrolysis and erythema multiforme have been reported with butalbital/acetaminophen/caffeine.[Ref]

Butalbital/Acetaminophen/Caffeine/Codeine:

Uncommon (0.1% to 1%): Hyperhidrosis, pruritus

Frequency not reported: Toxic epidermal necrolysis, erythema multiforme

Acetaminophen:

Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis

Frequency not reported: Rash[Ref]

Psychiatric

Butalbital/Acetaminophen/Caffeine/Codeine:

Uncommon (0.1% to 1%): Agitation, euphoria

Caffeine:

Frequency not reported: Irritability, dependence[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, abdominal pain

Uncommon (0.1% to 1%): Dry mouth, difficulty swallowing, heartburn, flatulence, constipation[Ref]

Renal

Butalbital/Acetaminophen/Caffeine/Codeine:

Uncommon (0.1% to 1%): Diuresis

Caffeine:

Frequency not reported: Nephrotoxicity[Ref]

Hematologic

Acetaminophen:

Frequency not reported: Thrombocytopenia, agranulocytosis[Ref]

Cardiovascular

Butalbital/Acetaminophen/Caffeine/Codeine:

Uncommon (0.1% to 1%): Tachycardia

Caffeine:

Frequency not reported: Cardiac stimulation[Ref]

Nervous system

Butalbital/Acetaminophen/Caffeine/Codeine:

Common (1% to 10%): Drowsiness, lightheadedness, dizziness, sedation

Uncommon (0.1% to 1%): Headache, shaky feeling, tingly, fainting, numbness, seizures, mental confusion, excitement or depression due to intolerance

Caffeine:

Frequency not reported: Tremor

Opioids:

Frequency not reported: Serotonin syndrome (with concomitant serotonergic drugs)[Ref]

Other

Common (1% to 10%): Intoxicated feeling

Uncommon (0.1% to 1%): Fatigue, high energy, heavy eyelids, sluggishness, hot spells, fever, earache, tinnitus

Metabolic

Caffeine:

Frequency not reported: Hyperglycemia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Leg pain, muscle fatigue[Ref]

Endocrine

Opioids:

Frequency not reported: Adrenal insufficiency, androgen deficiency

References

1. "Product Information. Fioricet with Codeine (acetaminophen / butalbital / caffeine / codeine)." Watson Pharmaceuticals, Parsippany, NJ.

2. "Product Information. APAP/Butalbital/Caffeine/Codeine (acetaminophen / butalbital / caffeine / codeine)." West-Ward Pharmaceutical Corporation, Eatontown, NJ.

Further information

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

Some side effects may not be reported. You may report them to the FDA.

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