Tylenol With Codeine #4 Side Effects

Generic name: acetaminophen / codeine

Medically reviewed by Drugs.com. Last updated on Aug 5, 2023.

Note: This document provides detailed information about Tylenol with Codeine #4 Side Effects associated with acetaminophen / codeine. Some dosage forms listed on this page may not apply specifically to the brand name Tylenol with Codeine #4.

Applies to acetaminophen / codeine: oral elixir, oral solution, oral tablet.

Precautions

It is very important that your doctor check your or your child's progress while you are taking this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your child has the following symptoms: an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, sneezing, weight loss, vomiting, yawning, or failure to gain weight. Check with your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect. Do not give this medicine to:

• Children younger than 12 years of age.
• Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.
• Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to morphine overdose in the nursing baby and cause very serious side effects.

For nursing mothers taking this medicine:

• Talk to your doctor if you have any questions about taking codeine or about how this medicine may affect your baby.
• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
• Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, confused, or disoriented. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink 3 or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of certain tests may be affected by this medicine.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects

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:

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

Other side effects

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:

For healthcare professionals

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

General adverse events

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

Acetaminophen-codeine:

• Frequency not reported: Shortness of breath

Acetaminophen:

• Frequency not reported: Bronchospasm

Codeine:

• Frequency not reported: Respiratory depression^[Ref]

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

Ocular

Opioids:

• Frequency not reported: Blurred or double vision^[Ref]

See also:

Further information

Tylenol with Codeine #4 side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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