Tylenol w/Codeine

• If you have an allergy to acetaminophen, codeine, or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking Tylenol w/ Codeine within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with Tylenol w/ Codeine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Acetaminophen and codeine oral suspension is used to relieve mild to moderate pain. The oral tablets are used to relieve mild to moderately severe pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including serious liver damage. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.

Codeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When codeine is used for a long time, it may become habit-forming, causing mental or physical dependence when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking the medicine. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

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]

Some side effects of Tylenol with Codeine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

• Effective combination drug for the relief of mild to moderately severe pain. Use is limited by the addiction and dependence potential of codeine; codeine can also cause constipation.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Stomach upsets including drowsiness and sleepiness, constipation, headache, sometimes abdominal pain or nausea (codeine component).
• Drowsiness may impair a person's reaction time and affect their ability to drive or operate machinery (codeine component). Avoid alcohol.
• Codeine is habit-forming and may be sought out by drug misusers. Do not overuse combination acetaminophen/codeine. Tolerance can also develop to codeine's analgesic effect and codeine may no longer work at the prescribed dosage.
• Marked differences may exist in the analgesic effect experienced between individuals due to genetic variations in the way codeine is metabolized to morphine.
• Rarely, serious, life-threatening, breathing problems (codeine component at higher dosages).
• Rarely, liver failure especially at dosages greater than 4000mg/day (acetaminophen component). Avoid taking extra acetaminophen while taking combination acetaminophen/codeine.
• People who are ultra fast metabolizers of codeine through CYP2D6 may be at risk of morphine toxicity. Babies exposed to breast milk of rapid codeine metabolizers who are taking Tylenol With Codeine are also at risk of morphine toxicity which may be fatal or life-threatening; symptoms include increased sleepiness, difficulty breastfeeding, breathing difficulties or floppiness - seek urgent medical help if you notice these signs. Avoid taking Tylenol With Codeine if you are breastfeeding.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.