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Fiortal with Codeine Side Effects

Generic name: aspirin / butalbital / caffeine / codeine

Medically reviewed by Last updated on Mar 28, 2024.

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

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


Oral route (Capsule)

Addiction, Abuse, and Misuse

Butalbital/aspirin/caffeine/codeine phosphate exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing codeine sulfate, and monitor all patients regularly for the development of these behaviors or conditions.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

:To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of butalbital/aspirin/caffeine/codeine phosphate. Monitor for respiratory depression, especially during initiation of butalbital/aspirin/caffeine/codeine phosphate or following a dose increase.

Accidental Ingestion

Accidental ingestion of even one dose of butalbital/aspirin/caffeine/codeine phosphate, especially by children, can result in a fatal overdose of butalbital/aspirin/caffeine/codeine phosphate.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of butalbital/aspirin/caffeine/codeine phosphate and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children

Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. Butalbital/aspirin/caffeine/codeine phosphate is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of butalbital/aspirin/caffeine/codeine phosphate in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine

Neonatal Opioid Withdrawal Syndrome

Prolonged use of butalbital/aspirin/caffeine/codeine phosphate during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Interactions with Drug Affecting Cytochrome P450 Isoenzymes

The effects of concomitant use or discontinuation of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with butalbital/aspirin/caffeine/codeine phosphate requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine.

Serious side effects

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:


Incidence not known

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

Symptoms of overdose

Other side effects

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:


Incidence not known

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)." Watson Pharmaceuticals

2. (2022) "Product Information. Ascomp with Codeine (aspirin / butalbital / caffeine / codeine)." NexGen Pharma

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.