Aspirin / Codeine Side Effects

Applies to aspirin / codeine: oral tablet.

Important warnings This medicine can cause some serious health issues

Codeine can slow or stop your breathing.

Never use this medicine in larger amounts, or for longer than prescribed. Codeine may also be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

Aspirin may cause stomach or intestinal bleeding, which can be fatal.

Get emergency medical help if you have any of these signs of an allergic reaction while taking aspirin / codeine: hives; runny nose, wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Seek emergency medical attention if a child taking this medicine has any of the following life-threatening side effects: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or hard to wake up; blue colored lips.

Call your doctor at once if you have:

• severe stomach pain or constipation, vomiting;

• easy bruising, unusual bleeding, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• weak or shallow breathing, fast or slow heartbeat;

• confusion, hallucinations, unusual thoughts or behavior, feeling like you might pass out;

• seizure (convulsions); or

• decreased hearing or ringing in the ears.

Common side effects may include:

• mild constipation, nausea;

• heartburn, upset stomach, bloating, gas, diarrhea;

• headache, dizziness, tired feeling; or

• mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to aspirin / codeine: oral tablet.

General

The more commonly reported adverse reactions have included nausea, dyspepsia, constipation, drowsiness, dizziness, and tinnitus.^[Ref]

Gastrointestinal

• Frequency not reported: Nausea, dyspepsia, vomiting, constipation, dry mouth, gastrointestinal bleeding or ulceration, biliary spasm, loss of appetite, paralytic ileus or toxic megacolon^[Ref]

Nervous system

• Frequency not reported: Drowsiness, confusion, headache, tinnitus^[Ref]

Hypersensitivity

Aspirin:

• Frequency not reported: Bronchospasm and asthma attacks or other hypersensitivity reactions including urticaria, rhinitis and angioneurotic edema in susceptible individuals^[Ref]

Other

Aspirin:

• Frequency not reported: Reye's syndrome

Codeine:

• Frequency not reported: Vertigo^[Ref]

Cardiovascular

• Frequency not reported: Hypotension, bradycardia, tachycardia, palpitations^[Ref]

Dermatologic

• Frequency not reported: Sweating, pruritus, angioedema, urticaria and other skin eruptions^[Ref]

Renal

Aspirin:

• Frequency not reported: Deterioration in renal function^[Ref]

Hematologic

Aspirin:

• Frequency not reported: Increased bleeding time, anemia, hemolytic anemia, hypoprothrombinemia, thrombocytopenia, aplastic anemia, pancytopenia^[Ref]

Hepatic

• Frequency not reported: Hepatitis, hepatotoxicity^[Ref]

Metabolic

• Frequency not reported: Dehydration, hyperkalemia, respiratory alkalosis and metabolic acidosis, (particularly during salicylate toxicity), hypoglycemia^[Ref]

Musculoskeletal

Aspirin:

• Frequency not reported: Rhabdomyolysis^[Ref]

Respiratory

Aspirin:

• Frequency not reported: Hyperpnea, pulmonary edema, tachypnea, bronchospasm

Codeine:

• Frequency not reported: Respiratory depression^[Ref]

Ocular

• Frequency not reported: Miosis, blurred or double vision^[Ref]

Psychiatric

Codeine:

• Frequency not reported: Confusion, mood changes, depression, trouble sleeping, withdrawal symptoms following regular prolonged use (restlessness irritability)^[Ref]

Genitourinary

Codeine:

• Frequency not reported: Ureteral spasm

Further information

Aspirin/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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer