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Tylenol with Codeine #4 Side Effects

Generic Name: acetaminophen / codeine

Note: This document contains side effect information about acetaminophen / codeine. Some of the dosage forms listed on this page may not apply to the brand name Tylenol with Codeine #4.

For the Consumer

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

Along with its needed effects, acetaminophen/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 acetaminophen / codeine:

More Common

  • Difficult or troubled breathing
  • irregular, fast or slow, or shallow breathing
  • pale or blue lips, fingernails, or skin

Incidence Not Known

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fever with or without chills
  • general feeling of tiredness or weakness
  • hives, itching, skin rash
  • hoarseness
  • 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
  • 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

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

Symptoms of Overdose

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

Some side effects of acetaminophen / 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:

More Common

  • Drowsiness
  • lightheadedness
  • relaxed and calm feeling
  • sleepiness

Incidence Not Known

  • Difficulty having a bowel movement
  • 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

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.

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