Acetaminophen/codeine oral tablet side effects: A detailed guide

This article describes possible side effects of acetaminophen/codeine oral tablet. To learn more about acetaminophen/codeine, including the drug’s uses, ways to save on cost, and more, talk with your doctor or pharmacist.

Acetaminophen/codeine oral tablet is a generic version of the brand-name drug Tylenol with Codeine. Acetaminophen/codeine also comes in a liquid solution that you take by swallowing, but that form isn’t described in this article. To learn more about that form, talk with your doctor.

Boxed warnings

Acetaminophen/codeine oral tablet has boxed warnings about the following risks. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

• risk of misuse and addiction
• risk of serious respiratory depression
• risk of accidental ingestion
• risk of serious respiratory depression in certain children
• risk of neonatal opioid withdrawal syndrome (NOWS)
• risk of serious effects if taken with certain medications
• risk of liver failure

To learn more about the risk of misuse and addiction, see the “Misuse and acetaminophen/codeine” section below. For more information about the risk of neonatal withdrawal syndrome, see the “Acetaminophen/codeine and pregnancy” section below. For all other details, see the “Side effects of acetaminophen/codeine in detail” section below.

More common side effects of acetaminophen/codeine

Acetaminophen/codeine oral tablet may cause mild or serious side effects. Below are some of the more common side effects of this medication.

Commonly reported side effects of acetaminophen/codeine oral tablet include:

• drowsiness
• lightheadedness
• dizziness
• nausea
• shortness of breath

Mild side effects of acetaminophen/codeine

Acetaminophen/codeine may cause certain mild side effects. Usually, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.

Mild side effects of acetaminophen/codeine oral tablet that occurred in studies include:

• drowsiness
• lightheadedness
• dizziness
• shortness of breath
• nausea
• vomiting
• sweating
• constipation*
• stomach pain
• itchiness
• rash
• flushing (temporary warmth, redness, or deepening of skin color)
• stomach cramps
• loss of appetite
• dry mouth
• anxiety
• headache
• nervousness
• shakiness
• vertigo (spinning sensation)
• mild allergic reaction*

Acetaminophen/codeine oral tablet may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.

* To learn more about this side effect, see the “Side effects of acetaminophen/codeine in detail” section below.

Serious side effects of acetaminophen/codeine

Acetaminophen/codeine may cause certain serious side effects. If you have any serious side effects from acetaminophen/codeine oral tablet, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.

After the FDA approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with acetaminophen/codeine.

Serious side effects of acetaminophen/codeine oral tablet that occurred in studies include:

• very low blood pressure
• heart palpitations (feeling of skipped or extra heartbeats)
• seizures
• withdrawal symptoms, including suicidal thoughts or behavior*
• agranulocytosis (low white blood cell count)
• thrombocytopenia (low level of platelets)
• pancreatitis (swelling of your pancreas)
• serotonin syndrome (high level of the chemical serotonin)
• adrenal insufficiency
• androgen deficiency
• risk of misuse and addiction†
• risk of serious respiratory depression‡
• risk of accidental ingestion‡
• risk of serious respiratory depression in certain children‡
• risk of neonatal opioid withdrawal syndrome (NOWS)^§
• risk of serious effects if taken with certain medications‡
• risk of liver failure
• severe allergic reaction*

* To learn more about this side effect, see the “Side effects of acetaminophen/codeine in detail” section below.
† Acetaminophen/codeine oral tablet has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Misuse and acetaminophen/codeine” section below.
‡ Acetaminophen/codeine oral tablet has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of acetaminophen/codeine in detail” section below.
§ Acetaminophen/codeine oral tablet has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Warnings for acetaminophen/codeine” section below.

Suicide prevention

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

• Call the 988 Suicide and Crisis Lifeline at 988.
• Text HOME to the Crisis Text Line at 741741.
• Not in the United States? Find a helpline in your country with Befrienders Worldwide.
• Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you are not in the same household, stay on the phone with them until help arrives.

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Common questions about side effects of acetaminophen/codeine

Here are answers to some common questions about side effects of acetaminophen/codeine oral tablet. If you have other questions, talk with your doctor or pharmacist.

Is acetaminophen/codeine safe for older adults?

Maybe. But older adults (65 years and older) may be more sensitive to the effects of acetaminophen/codeine.

Compared with younger adults, older adults may also clear acetaminophen/codeine more slowly from their body. This means the drug can reach higher levels in the body, which increases the risk of side effects. The main concern with side effects is respiratory depression. You can read more about this in the “Side effects of acetaminophen/codeine in detail” section below.

Due to these risks, the drugmaker recommends older adults start at the lower end of the recommended dosage range of acetaminophen/codeine.

If you have questions about the right dosage of acetaminophen/codeine for you, talk with your doctor.

Does acetaminophen/codeine cause long-term side effects?

Yes, in some cases acetaminophen/codeine oral tablet may cause long-term side effects. This drug contains codeine, which is an opioid. Long-term side effects can occur if you take any opioid for a long time. Note that acetaminophen/codeine is typically prescribed as a short-term treatment.

Examples of long-term side effects reported with acetaminophen/codeine oral tablet include:

• dependence
• addiction
• adrenal insufficiency, which may result in fertility problems or sexual side effects such as erectile dysfunction

Talk with your doctor to learn more about these side effects and how to manage them. Ask your doctor for more information about how long these side effects of acetaminophen/codeine may last.

Misuse and acetaminophen/codeine

Acetaminophen/codeine has a risk of misuse. Misuse means taking a drug in a way other than how it’s prescribed. An example of this is taking a prescription drug to get “high.”

Acetaminophen/codeine also has a risk of addiction. Addiction refers to feeling unable to stop taking a drug, even though it may be causing harm. This can occur even if the drug is taken at the recommended dosage or if the drug is misused.

To help lower the risk of misuse and addiction, doctors may prescribe acetaminophen/codeine through the opioid analgesic risk evaluation and mitigation strategy (REMS) program. This program ensures the drug is prescribed safely.

Side effects of acetaminophen/codeine in detail

Below you’ll find details on some of the side effects of acetaminophen/codeine oral tablet.

Boxed warnings

Below are details about some of the boxed warnings for acetaminophen/codeine.

Risk of serious respiratory depression

Acetaminophen/codeine can cause serious and life threatening respiratory depression, which is when your breathing becomes very slow or shallow. This can occur at any time during treatment, but the risk is greatest when you first start taking the drug or when your doctor increases your dosage. If symptoms of respiratory depression aren’t recognized and treated right away, it can lead to death.

Symptoms can include:

• shallow breathing
• long pauses between breaths
• excessive sleepiness
• confusion
• changes in skin color

Ways to manage

If you or your loved ones notice your breathing becoming slow or shallow or if you have any trouble breathing, call 911 to seek emergency medical help right away.

Your doctor may prescribe naloxone (Narcan, Kloxxado) with acetaminophen/codeine. Some pharmacies have naloxone available without a prescription. Naloxone is a drug that can temporarily treat respiratory depression while you wait for emergency medical care. If you have naloxone on hand, be sure that you, your loved ones, and your caregiver know how to administer a dose. Talk with your doctor or pharmacist if you have more questions about this.

Risk of accidental ingestion

Accidentally taking even one dose of acetaminophen/codeine can cause an overdose. This can be fatal, especially for children.

Ways to manage

To reduce the risk of accidental ingestion, store acetaminophen/codeine in a secure place where it cannot be seen or accessed by others. If anyone accidentally ingests a dose of acetaminophen/codeine, call 911 right away.

Risk of serious respiratory depression in certain children

Acetaminophen/codeine can cause serious respiratory depression in children. This can lead to slow and shallow breathing.

In some children, codeine can reach high levels in the body. This can increase the risk of serious side effects, including respiratory depression. Respiratory depression can be life threatening and lead to death if it’s not recognized and treated.

Because of this risk, doctors will not prescribe acetaminophen/codeine for:

• children under age 12 years
• children under age 18 years after surgery to remove their tonsils or adenoids
• children ages 12–18 years who may be at higher risk of respiratory depression, such as children with obstructive sleep apnea, obesity, or lung problems

Ways to manage

If your child experiences any symptoms of respiratory depression, seek emergency medical help right away.

Risk of serious effects if taken with certain medications

Acetaminophen/codeine slows your central nervous system (CNS). Taking it with other medications that slow the CNS can increase the risk of serious side effects, including respiratory depression, extreme sleepiness, coma, or death.

Certain other medications can alter the levels of acetaminophen/codeine in your body. This can increase the risk of serious side effects, or it can make acetaminophen/codeine less effective and cause withdrawal symptoms. (Withdrawal symptoms are uncomfortable side effects that can occur when you stop taking a drug your body is used to.)

Ways to manage

If you experience unusual side effects, such as difficulty breathing, severe sleepiness, decreased awareness, or a bluish skin color, get emergency medical help.

Be sure to talk with your doctor about all medications you take before you start treatment with acetaminophen/codeine. This includes vitamins and herbal supplements. Also, talk with your doctor or pharmacist before starting or stopping any medications.

Risk of liver failure

Acetaminophen can increase the risk of serious and life threatening liver problems, including sudden liver failure that may result in needing a liver transplant. This risk is higher if you:

• take more than 4,000 milligrams (mg) of acetaminophen per day
• have liver disease
• take more than one drug containing acetaminophen
• drink alcohol

Many over-the-counter (OTC) medications contain acetaminophen. Before starting any new medications, be sure to check whether they contain acetaminophen. If you’re unsure, talk with your doctor or pharmacist.

Ways to manage

If you experience symptoms of liver problems, such as yellowing skin or eyes, stomach pain, loss of appetite, or itchiness, get medical help. If you accidentally take more than 4,000 mg of acetaminophen in 1 day, seek emergency medical care even if you feel well.

Constipation

Acetaminophen/codeine can cause constipation. This side effect may be mild or serious. And taking certain other drugs, such as anticholinergic drugs, with acetaminophen/codeine can increase the risk of constipation.

Symptoms of constipation include:

• straining or pain during bowel movements
• trouble passing stool
• hard, dry bowel movements

Ways to manage

If you experience constipation, tell your doctor or pharmacist. Depending on the severity, they’ll likely recommend diet changes or over-the-counter or prescription drugs.

Withdrawal symptoms

Acetaminophen/codeine can cause dependence and withdrawal symptoms. With dependence, your body needs the drug to function as usual. Withdrawal symptoms are side effects that can occur when you stop taking a drug that your body has become dependent on.

Symptoms of acetaminophen/codeine withdrawal include:

• restlessness
• watery eyes
• runny nose
• sweating
• muscle pain
• anxiety
• trouble sleeping
• fast heart rate
• fast breathing
• suicidal thoughts or behavior

Certain factors can increase the risk of withdrawal symptoms with acetaminophen/codeine oral tablet. These include suddenly stopping or lowering the dosage of the drug or taking acetaminophen/codeine with certain other medications. Examples include buprenorphine (Belbuca, Sublocade) and naltrexone (Vivitrol).

Ways to manage

To lower the risk of withdrawal symptoms, doctors will likely reduce your dosage of acetaminophen/codeine slowly over time until it’s safe for you to stop it completely. Do not stop taking acetaminophen/codeine without talking with your doctor first.

Allergic reaction

For some people, acetaminophen/codeine oral tablet can cause an allergic reaction.

Symptoms can be mild or serious, and they may include:

• itchiness
• skin rash
• swelling under the skin, usually affecting eyelids, lips, hands, or feet
• swelling of the mouth, tongue, or throat, which can make it hard to breathe
• flushing (temporary warmth, redness, or deepening of skin color)

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to acetaminophen/codeine oral tablet, your doctor may recommend taking a different medication instead.

Warnings for acetaminophen/codeine

Below are some factors you may want to discuss with your doctor before taking acetaminophen/codeine oral tablet.

Boxed warnings

This drug has boxed warnings about the following risks. A boxed warning is the most serious warning from the FDA.

• misuse and addiction
• serious respiratory depression
• accidental ingestion
• serious respiratory depression in certain children
• neonatal opioid withdrawal syndrome (NOWS)
• serious effects if taken with certain medications
• liver failure

To learn more about the risk of misuse and addiction, see the “Misuse and acetaminophen/codeine” section above. For more information about the risk of neonatal withdrawal syndrome, see the “Acetaminophen/codeine and pregnancy” section below. For all other details, see the “Side effects of acetaminophen/codeine in detail” section above.

Other warnings

It may not be safe for you to take acetaminophen/codeine oral tablet if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether acetaminophen/codeine oral tablet is a safe treatment option for you.

Before taking acetaminophen/codeine oral tablet, tell your doctor about your health and medications you take. Things to consider include:

• lung or breathing conditions, such as severe asthma
• digestive problems, such as an intestinal blockage
• seizures
• liver problems
• past allergic reaction to acetaminophen/codeine

Acetaminophen/codeine and pregnancy

There may be certain risks associated with taking acetaminophen/codeine during pregnancy.

Risk of neonatal opioid withdrawal syndrome

Acetaminophen/codeine has a boxed warning about the risk of neonatal opioid withdrawal syndrome (NOWS) if taken for a long period of time during pregnancy. (Withdrawal symptoms are side effects that can occur when you stop taking a drug on which your body is dependent. Dependence means your body needs the drug to function as usual.) In this case, withdrawal symptoms affect your newborn.

Symptoms of NOWS include:

• stiffness or tight muscle tone
• tremor
• extremely high fever
• sweating
• high-pitched crying

Acetaminophen/codeine and breastfeeding

Acetaminophen/codeine oral tablet should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your child during treatment with acetaminophen/codeine.

Acetaminophen/codeine and alcohol

Acetaminophen/codeine oral tablet is known to interact with alcohol. Drinking alcohol while taking acetaminophen/codeine can cause serious side effects, including respiratory depression, extreme sleepiness, coma, low blood pressure, and death.

If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with acetaminophen/codeine oral tablet. Your doctor will likely advise you to avoid consuming alcohol while taking this drug.

What to ask your doctor

This article describes common and serious side effects of acetaminophen/codeine oral tablet. If your doctor prescribes this medication, they can discuss possible side effects with you. Let your doctor know if you have concerns or questions about treatment with this medication.

Here’s a list of questions you may want to ask your doctor:

• Will my risk of side effects increase if I take other drugs with acetaminophen/codeine?
• How can I lower my risk of side effects from acetaminophen/codeine?
• Do I have a higher risk of dependence and addiction?

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.