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Acetaminophen / codeine Side Effects

Not all side effects for acetaminophen / codeine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to acetaminophen / codeine: oral capsule, oral elixir, oral solution, oral suspension, oral tablet

In addition to its needed effects, some unwanted effects may be caused by acetaminophen / codeine. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking acetaminophen / codeine:

More common
  • Difficult or troubled breathing
  • irregular, fast or slow, or shallow breathing
  • pale or blue lips, fingernails, or skin
  • shortness of breath
Incidence not known
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • cough or hoarseness
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fever with or without chills
  • general feeling of tiredness or weakness
  • hives
  • itching
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • tightness in the chest
  • unusual bleeding or bruising
  • unusual tiredness or weakness

If any of the following symptoms of overdose occur while taking acetaminophen / codeine, get emergency help immediately:

Symptoms of overdose
  • Abdominal or stomach pain
  • bloody or cloudy urine
  • chills
  • constricted, pinpoint, or small pupils (black part of the eye)
  • convulsions
  • dark urine
  • headache
  • increased sweating
  • light-colored stools
  • loss of appetite
  • loss of consciousness
  • nausea
  • sudden decrease in amount of urine
  • unpleasant breath odor
  • vomiting
  • vomiting of blood
  • yellow eyes or skin

Some of the side effects that can occur with acetaminophen / codeine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Drowsiness
  • lightheadedness
  • relaxed and calm
  • sleepiness
Incidence not known
  • Difficulty having a bowel movement (stool)
  • false or unusual sense of well-being

For Healthcare Professionals

Applies to acetaminophen / codeine: oral capsule, oral liquid, oral suspension, oral tablet

General

The most frequently observed adverse reactions include drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, and vomiting.[Ref]

Nervous system

Acetaminophen-codeine:
Common (1% to 10%): Drowsiness, dizziness
Frequency not reported: Lightheadedness, sedation, medication over-use headache

Acetaminophen:
Frequency not reported: Drowsiness, impaired mental functions

Opioids:
Frequency not reported: Confusion, drowsiness, vertigo, dizziness, CNS excitation (restlessness/excitement), convulsions, headache, raised intracranial pressure[Ref]

Gastrointestinal

Acetaminophen-codeine:
Frequency not reported: Nausea, vomiting, constipation, abdominal pain

Acetaminophen:
Very rare (less than 0.01%): Pancreatitis
Frequency not reported: Dyspepsia

Opioids:
Frequency not reported: Constipation, GI irritation, biliary spasm, nausea, vomiting, loss of appetite, dry mouth, paralytic ileus, toxic megacolon[Ref]

Hepatic

Acetaminophen:
Frequency not reported: Acute liver failure, hepatotoxicity, chronic hepatic necrosis, cytolytic hepatitis[Ref]

Psychiatric

Acetaminophen-codeine:
Frequency not reported: Euphoria, dysphoria

Opioid:
Frequency not reported: Confusion, changes in mood, hallucinations, mental depression, trouble sleeping or nightmares, tolerance or dependence[Ref]

Renal

Acetaminophen-codeine:
Frequency not reported: Renal failure, uremia

Acetaminophen:
Frequency not reported: Nephrotoxicity, papillary necrosis[Ref]

Hypersensitivity

Acetaminophen-codeine:
Frequency not reported: Allergic reactions

Acetaminophen:
Rare (less than 0.1%): Allergic reactions including skin rash, drug fever, mucosal lesions
Postmarketing reports: Hypersensitivity including swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting, anaphylaxis, angioedema

Opioids:
Frequency not reported: Rash, urticaria, difficulty breathing, increased sweating, redness, redness or flushed face[Ref]

Cardiovascular

Acetaminophen:
Frequency not reported: Toxic myocarditis, Kounis syndrome

Opioids:
Frequency not reported: Bradycardia, palpitations, hypotension[Ref]

Genitourinary

Acetaminophen-codeine:
Frequency not reported: Urinary retention or hesitance

Opioids:
Frequency not reported: Urinary retention, ureteral spasm, antidiuretic effect[Ref]

Hematologic

Acetaminophen-codeine:
Frequency not reported: Thrombocytopenia, agranulocytosis, anemia

Acetaminophen:
Very rare (less than 0.01%): Thrombocytopenia, neutropenia, leucopenia
Frequency not reported: Agranulocytosis, methemoglobinemia, pancytopenia, thrombocytopenia purpura, hemolytic anemia[Ref]

Dermatologic

Acetaminophen-codeine:
Frequency not reported: Pruritus, rash

Acetaminophen:
Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN)
Frequency not reported: Sweating, fixed drug eruption[Ref]

Respiratory

In patients with a tendency of analgesic asthma acetaminophen-use has triggered bronchospasms.[Ref]

Acetaminophen-codeine:
Frequency not reported: Shortness of breath

Acetaminophen:
Frequency not reported: Bronchospasm

Codeine:
Frequency not reported: Respiratory depression[Ref]

Ocular

Opioids:
Frequency not reported: Blurred or double vision[Ref]

References

1. "Product Information. Acetaminophen-Codeine Phosphate (acetaminophen-codeine)." Qualitest Pharmaceuticals Inc, Huntsville, ON.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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