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Fiortal with Codeine Side Effects

Generic Name: aspirin / butalbital / caffeine / codeine

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

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:

  • Back, leg, or stomach pains
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • blood in the vomit
  • 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 or vomiting
  • 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 skin
  • 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
  • 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
  • convulsions
  • difficult or troubled breathing
  • drowsiness
  • extremely high fever or body temperature
  • hallucinations
  • headache
  • 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
  • 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:

  • 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 (stool)
  • 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


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


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


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]


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

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


Uncommon (0.1% to 1%): Fatigue, heavy eyelids, high energy, hot spells, sluggishness, fever, earache, tinnitus
Postmarketing reports: Vertigo[Ref]


Uncommon (0.1% to 1%): Tachycardia
Postmarketing reports: Flushing, chest pain, hypotensive reaction, palpitations, syncope, edema[Ref]


Uncommon (0.1% to 1%): Diuresis
Postmarketing reports: Urinary difficulty[Ref]


Uncommon (0.1% to 1%): Hyperhidrosis, pruritus
Postmarketing reports: Erythema, erythema multiforme, exfoliative dermatitis, hives, rash, toxic epidermal necrolysis[Ref]


Postmarketing reports: Kidney impairment[Ref]


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


Uncommon (0.1% to 1%): Nasal congestion
Postmarketing reports: Epistaxis, hiccup[Ref]


Postmarketing reports: Miosis[Ref]


Postmarketing reports: Cholangiocarcinoma[Ref]


Postmarketing reports: Adrenal insufficiency, androgen deficiency


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.

Some side effects of Fiortal with Codeine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

More about Fiortal with Codeine (aspirin / butalbital / caffeine / codeine)

Consumer resources

Other brands: Ascomp with Codeine, Fiorinal with Codeine

Professional resources

Related treatment guides

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. 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.