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Fiortal with Codeine Side Effects

Generic Name: aspirin / butalbital / caffeine / codeine

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

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by aspirin / 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 aspirin / butalbital / caffeine / codeine:

Rare
  • 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, 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

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

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

Minor Side Effects

Some of the side effects that can occur with aspirin / 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:

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 (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

General

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

Hypersensitivity

Postmarketing reports: Allergic reaction, anaphylactic shock[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[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]

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.

Not all side effects for Fiortal 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.

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

Consumer resources

Professional resources

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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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