August 31, 2016
Recommended Topic Related To:

Empirin Codeine

"July 10, 2015 -- Popular painkillers like ibuprofen and naproxen have carried warnings for years about potential risks of heart attacks and strokes. This week, the FDA decided to strengthen those warnings on the medications, known as nonsteroidal"...


Empirin Codeine

Empirin Codeine Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/4/2016

Empirin Codeine (aspirin and codeine) is a combination of a narcotic pain reliever and a less potent pain reliever and fever reducer used to treat moderate to severe pain. Empirin Codeine is available in generic form. Common side effects of Empirin Codeine include constipation, nausea, vomiting, heartburn, upset stomach, bloating, gas, diarrhea, dizziness, tired feeling, headache, sweating, increased thirst, or mild itching or skin rash.

The usual adult dose for Aspirin and Codeine 30 mg is one or two tablets every four hours as needed. The usual adult dose for Aspirin and Codeine 60 mg is one tablet every four hours as needed. Empirin Codeine may interact with glycopyrrolate, mepenzolate, atropine, benztropine, dimenhydrinate, methscopolamine, scopolamine, bladder or urinary medications, bronchodilators, or irritable bowel medications. Tell your doctor all medications you use. During pregnancy, Empirin Codeine should be used only if prescribed. It may be harmful to a fetus, and could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Aspirin and codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Consult your doctor before breastfeeding. Codeine may be habit-forming. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Empirin Codeine (aspirin and codeine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Empirin Codeine in Detail - Patient Information: Side Effects

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

Seek emergency medical attention if a child taking this medication 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 a serious side effect such as:

  • severe stomach pain or constipation, vomiting;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • shallow breathing, fast or slow heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior, feeling like you might pass out;
  • easy bruising or bleeding;
  • seizure (convulsions); or
  • decreased hearing or ringing in the ears.

Less serious 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Empirin Codeine (Aspirin and Codeine)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Empirin Codeine Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Empirin Codeine (Aspirin and Codeine)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Empirin Codeine FDA Prescribing Information: Side Effects
(Adverse Reactions)



The most frequently observed adverse reactions to codeine include light-headedness, dizziness, drowsiness, nausea, vomiting, constipation and depression of respiration. Less common reactions to codeine include euphoria, dysphoria, pruritus and skin rashes.


Mild aspirin intoxication (salicylism) can occur in response to chronic use of large doses. Manifestations include nausea, vomiting, hearing impairment, tinnitus, diminished vision, headache, dizziness, drowsiness, mental confusion, hyperpnea, hyperventilation, tachycardia, sweating and thirst.

Therapeutic doses of aspirin can induce mild or severe allergic reactions manifested by skin rashes, urticaria, angioedema, rhinorrhea, asthma, abdominal pain, nausea, vomiting, or anaphylactic shock. A history of allergy is often lacking, and allergic reactions may occur even in patients who have previously taken aspirin without any ill effects. Allergic reactions to aspirin are most likely to occur in patients with a history of allergic disease, especially in patients with nasal polyps or asthma.

Some patients are unable to take aspirin or other salicylates without developing nausea or vomiting. Occasional patients respond to aspirin (usually in large doses) with dyspepsia or heartburn, which may be accompanied by occult bleeding. Excessive bruising or bleeding is sometimes seen in patients with mild disorders of primary hemostasis who regularly use low doses of aspirin.

Prolonged use of aspirin can cause painless erosion of gastric mucosa, occult bleeding and infrequently, iron-deficiency anemia. High doses of aspirin can exacerbate symptoms of peptic ulcer and occasionally, cause extensive bleeding.

Excessive bleeding can follow injury or surgery in patients with or without known bleeding disorders who have taken therapeutic doses of aspirin within the preceding 10 days. Hepatotoxicity has been reported in association with prolonged use of large doses of aspirin in patients with lupus erythematosus, rheumatoid arthritis and rheumatic disease. Bone marrow depression, manifested by weakness, fatigue, or abnormal bruising or bleeding, has occasionally been reported. In patients with glucose-6-phosphate dehydrogenase deficiency, aspirin can cause a mild degree of hemolytic anemia. In hyperuricemic persons, low doses of aspirin may reduce the effectiveness of uricosuric therapy or precipitate an attack of gout.


Like other medications containing a narcotic analgesic, aspirin and codeine (aspirin and codeine (aspirin and codeine) ) phosphate tablets are controlled by the Drug Enforcement Administration and is classified under Schedule III.

Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) can produce drug dependence of the morphine type; therefore, it has a potential for being abused. Psychic dependence, physical dependence and tolerance may develop on repeated administration.

The dependence liability of codeine has been found to be too small to permit a full definition of its characteristics. Studies indicate that addiction to codeine is extremely uncommon and requires very high parenteral doses.

When dependence on codeine occurs at therapeutic doses, it appears to require from one to two months to develop, and withdrawal symptoms are mild. Most patients on long-term oral codeine therapy show no signs of physical dependence upon abrupt withdrawal.

Read the entire FDA prescribing information for Empirin Codeine (Aspirin and Codeine)

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Chronic Pain/Back Pain

Find tips and advances in treatment.