Aspirin / Butalbital / Caffeine / Codeine Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 6, 2024.

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

Precautions

It is very important that your doctor check your or your child's progress while using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor 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.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant, especially during the later part of pregnancy may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect. Do not give this medicine to:

• Children younger than 12 years of age.
• Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.
• Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects.

For nursing mothers using this medicine:

• Talk to your doctor if you have any questions about using codeine or about how this medicine may affect your baby.
• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
• Check with your doctor or hospital emergency room right away if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

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 may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroids or a blood thinner).

This medicine may make you dizzy, drowsy, confused, or disoriented. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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 serious skin reaction including drug reaction with eosinophilia and systemic symptoms (DRESS).

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. Your doctor may also give naloxone to treat an overdose. Signs of an overdose include: cold, clammy skin, coughing that sometimes produces a pink frothy sputum, seizures, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, swelling in the legs and ankles, or trouble sleeping.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (unable to have children) or may cause a delay in ovulation for women and may affect their ability to have children. Talk with your doctor before using this medicine if you plan to have children.

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.

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:

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

Symptoms of overdose

• cold and clammy skin
• confusion as to time, place, or person
• continuing ringing or buzzing or other unexplained noise in the ears
• coughing that sometimes produces a pink frothy sputum
• difficult or trouble breathing
• drowsiness
• extremely high fever or body temperature
• hearing loss
• holding false beliefs that cannot be changed by fact
• increased sweating
• irregular, fast or slow, or shallow breathing
• loss of consciousness
• muscle cramps
• pale or blue lips, fingernails, or skin
• pinpoint pupils (black part of the eyes)
• restlessness
• seeing, hearing, or feeling things that are not there
• seizures
• swelling in the legs and ankles
• trouble sleeping
• unusual bleeding or bruising

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:

For healthcare professionals

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

General adverse events

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

See also:

Further information

Aspirin/butalbital/caffeine/codeine 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.

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