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Empirin with Codeine Side Effects

Generic name: aspirin / codeine

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

Applies to aspirin / codeine: oral tablet.


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:

Common side effects may include:

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.


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


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]



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



Frequency not reported: Reye's syndrome


Frequency not reported: Vertigo[Ref]


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


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



Frequency not reported: Deterioration in renal function[Ref]



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


Frequency not reported: Hepatitis, hepatotoxicity[Ref]


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



Frequency not reported: Rhabdomyolysis[Ref]



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


Frequency not reported: Respiratory depression[Ref]


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



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



Frequency not reported: Ureteral spasm


1. "Multum Information Services, Inc. Expert Review Panel"

2. Lanas A, Serrano P, Bajador E, Esteva F, Benito R, Sainz R (1997) "Evidence of aspirin use in both upper and lower gastrointestinal perforation." Gastroenterology, 112, p. 683-9

3. Petty GW, Brown RD, Whisnant JP, Sicks JD, O'Fallon WM, Wiebers DO (1999) "Frequency of major complications of aspirin, warfarin, and intravenous heparin for secondary stroke prevention: a population study." Ann Intern Med, 130, p. 14-22

4. Cerner Multum, Inc. "UK Summary of Product Characteristics."

5. Cerner Multum, Inc. "Australian Product Information."

6. (2002) "Product Information. Calcidrine (codeine)." Abbott Pharmaceutical

7. Gonzalogarijo MA, Revengaarranz F (1996) "Fixed drug eruption due to codeine." Br J Dermatol, 135, p. 498-9

8. Hill SA, Quinn K, Shelly MP, Park GR (1991) "Reversible renal failure following opioid administration." Anaesthesia, 46, p. 938-9

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.