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Fioricet with Codeine Side Effects

Generic Name: acetaminophen / butalbital / caffeine / codeine

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

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by acetaminophen / butalbital / caffeine / codeine. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking acetaminophen / butalbital / caffeine / codeine:

Less common:
  • Confusion (mild)
  • mental depression
  • unusual excitement (mild)
Rare
  • Bleeding or crusting sores on the lips
  • chest pain
  • convulsions
  • fever with or without chills
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • hive-like swellings on the eyelids, face, lips, or tongue
  • hives
  • itching
  • muscle cramps or pain
  • red, thickened, or scaly skin
  • skin rash
  • sores, ulcers, or white spots in the mouth
  • sore throat
  • swollen or painful glands
  • tightness in the chest
  • troubled breathing

If any of the following symptoms of overdose occur while taking acetaminophen / butalbital / caffeine / codeine, get emergency help immediately:

Symptoms of overdose:
  • Anxiety (severe)
  • cold and clammy skin
  • confusion (severe)
  • convulsions (seizures)
  • dizziness, lightheadedness, drowsiness, or weakness (severe)
  • excitement (severe)
  • increased sleepiness in babies (more than usual)
  • increased sweating
  • irritability (severe)
  • limpness (in babies)
  • nausea or vomiting
  • restlessness (severe)
  • shortness of breath or unusually slow or troubled breathing
  • 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)

Minor Side Effects

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

More common:
  • Bloated or "gassy" feeling
  • dizziness or lightheadedness (mild)
  • drowsiness (mild)
  • nausea
  • stomach pain (mild)
  • vomiting

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

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]

Common (1% to 10%): Shortness of breath
Uncommon (0.1% to 1%): Nasal congestion

Codeine:
Postmarketing reports: Respiratory depression including deaths[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[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]

References

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

Not all side effects for Fioricet with Codeine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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