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Aspirin / butalbital / caffeine / codeine Side Effects

For the Consumer

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

Along with its needed effects, aspirin/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 aspirin/butalbital/caffeine/codeine:

Rare

  • Back, leg, or stomach pains
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloody urine
  • blurred vision
  • chills, fever
  • confusion
  • cough
  • dark urine
  • decreased frequency or amount of urine
  • diarrhea
  • difficulty breathing
  • difficulty swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, irregular, pounding, or racing heartbeat or pulse
  • general tiredness and weakness
  • headache
  • hives, itching, or skin rash
  • increased thirst
  • joint or muscle pain
  • light-colored stools
  • lower back or side pain
  • nausea
  • nosebleeds
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • shakiness in the legs, arms, hands, or feet
  • sores, ulcers, or white spots in the mouth or on the lips
  • sweating
  • swelling of the face, fingers, or lower legs
  • tightness or pain in the chest
  • trembling or shaking of the hands or feet
  • upper right abdominal or stomach pain
  • vomiting
  • vomiting blood
  • weight gain
  • yellow eyes and skin

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

Symptoms of Overdose

  • Confusion as to time, place, or person
  • continuing ringing or buzzing or other unexplained noise in the ears
  • difficult or troubled breathing
  • drowsiness
  • extremely high fever or body temperature
  • hallucinations
  • hearing loss
  • holding false beliefs that cannot be changed by fact
  • irregular, fast or slow, or shallow breathing
  • loss of consciousness
  • muscle cramps
  • pale or blue lips, fingernails, or skin
  • pale, clammy skin
  • pinpoint pupils (black part of the eyes)
  • restlessness
  • seizures
  • trouble sleeping
  • unusual bleeding or bruising

Some side effects of aspirin / 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:

Rare

  • Anxiety
  • blurred vision
  • burning, tingling, numbness, or pain in the hands, arms, feet, or legs
  • confusion about identity, place, and time
  • constricted, pinpoint, or small pupils (black part of the eye)
  • depression
  • difficulty having a bowel movement
  • dry mouth
  • feeling of constant movement of self or surroundings
  • feeling of warmth
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • heartburn
  • high energy
  • hyperventilation
  • irregular heartbeats
  • irritability
  • loss in sexual ability, desire, drive, or performance
  • pain in the legs
  • redness of the face, neck, arms, and occasionally, upper chest
  • sensation of spinning
  • severe mood or mental changes
  • shaking
  • sleepiness
  • sluggishness
  • slurred speech
  • trouble sitting still
  • unexplained weight loss
  • unusual behavior
  • weakness

For Healthcare Professionals

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

General

The most common adverse reactions have included nausea and/or abdominal pain, drowsiness, and dizziness.[Ref]

Hypersensitivity

Postmarketing reports: Allergic reaction, anaphylactic shock, anaphylaxis[Ref]

Gastrointestinal

Common (1% to 10%): Nausea/abdominal pain

Uncommon (0.1% to 1%): Dry mouth, vomiting, difficulty swallowing, heartburn

Postmarketing reports: Salivation, anorexia, increased appetite, constipation, diarrhea, esophagitis, gastroenteritis, gastrointestinal spasm, mouth burning, pyloric ulcer, stomach upset[Ref]

Psychiatric

Uncommon (0.1% to 1%): Agitation

Postmarketing reports: Abuse, addiction, anxiety, depression, hallucination, insomnia, libido decreased, nervousness, psychosis, increased sexual activity[Ref]

Nervous system

Common (1% to 10%): Drowsiness, dizziness/lightheadedness, feeling intoxicated

Uncommon (0.1% to 1%): Headache, shaky feeling, tingling, fainting, numbness

Postmarketing reports: Hyperactivity, disorientation, sedation, slurred speech, twitching, unconsciousness

Opioids:

Postmarketing reports: Serotonin syndrome (with concomitant use with serotonergic drugs)[Ref]

Other

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

Postmarketing reports: Vertigo[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia

Postmarketing reports: Flushing, chest pain, hypotensive reaction, palpitations, syncope, edema[Ref]

Genitourinary

Uncommon (0.1% to 1%): Diuresis

Postmarketing reports: Urinary difficulty[Ref]

Dermatologic

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

Postmarketing reports: Erythema, erythema multiforme, exfoliative dermatitis, hives, rash, toxic epidermal necrolysis[Ref]

Renal

Postmarketing reports: Kidney impairment[Ref]

Musculoskeletal

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

Respiratory

Uncommon (0.1% to 1%): Nasal congestion

Postmarketing reports: Epistaxis, hiccup[Ref]

Ocular

Postmarketing reports: Miosis[Ref]

Oncologic

Postmarketing reports: Cholangiocarcinoma[Ref]

Endocrine

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency

References

1. "Product Information. Fiorinal with Codeine (aspirin / butalbital / caffeine / codeine (ASA/butalbital/caffeine/codeine))." Watson Pharmaceuticals, Parsippany, NJ.

2. "Product Information. Ascomp with Codeine (aspirin / butalbital / caffeine / codeine (ASA/butalbital/caffeine/codeine))." NexGen Pharma, Irvine, CA.

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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