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Aspirin / Butalbital / Caffeine Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 13, 2025.

Applies to aspirin / butalbital / caffeine: oral capsule, oral tablet.

Precautions

It is very important that your doctor check your progress while using this medicine to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine during the later part of your pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Aspirin may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, hives, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: bleeding under the skin, blurred vision, change in consciousness, confusion, confusion as to time, place, or person, continuing ringing or buzzing or other unexplained noise in the ears, difficult or labored breathing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying position, extremely high fever or body temperature, hallucinations, irregular, fast, slow, or shallow breathing, fast, weak heartbeat, headache, hearing loss, holding false beliefs that cannot be changed by fact, loss of consciousness, muscle cramps, pale, clammy skin, pale or blue lips, fingernails, or skin, shakiness in the legs, arms, hands, feet, stomach pain, sweating, thirst, trembling or shaking of the hands or feet, trouble sleeping, unusual bleeding or bruising, unusual excitement, nervousness, or restlessness, unusual tiredness or weakness, or vomiting.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs.

Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Other side effects

Some side effects of aspirin / butalbital / caffeine 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:

More common side effects

  • dizziness
  • drowsiness

Serious side effects

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

Less common side effects

  • diarrhea
  • indigestion
  • loss of appetite
  • nausea or vomiting
  • passing gas
  • stomach pain, fullness, or discomfort

Incidence not known

  • blistering, peeling, or loosening of the skin
  • chest pain
  • chills
  • cough or hoarseness
  • fever
  • itching
  • joint or muscle pain
  • lower back or side pain
  • painful or difficult urination
  • red irritated eyes
  • red skin lesions, often with a purple center
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • trouble breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness

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

Symptoms of overdose

For healthcare professionals

Applies to aspirin / butalbital / caffeine: oral capsule, oral tablet.

General adverse events

The most common adverse reactions have included drowsiness and dizziness.[Ref]

Nervous system

Gastrointestinal

Hematologic

Hypersensitivity

Dermatologic

See also:

References

1. (2022) "Product Information. Fiorinal (aspirin / butalbital / caffeine)." Actavis (formerly Abrika Pharmaceuticals LLP)

2. (2022) "Product Information. Aspirin/Butalbital/Caffeine (aspirin / butalbital / caffeine)." Major Pharmaceuticals Inc

Further information

Aspirin/butalbital/caffeine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.