Acetaminophen / Caffeine / Dihydrocodeine Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 23, 2023.

Applies to acetaminophen / caffeine / dihydrocodeine: oral capsule, oral tablet.

Precautions

It is very important that your doctor check your progress while you are using 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 should continue to take it.

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.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), 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. Check with your doctor before taking any of these medicines while you are using 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 troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

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 a 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, hospital emergency room, or local emergency services (eg, "call 9-1-1") right away 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.

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.

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 convulsions (seizures), hallucinations, stomach or muscle cramps, tremors, or unusual behavior.

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 you think you are pregnant or if you plan to become pregnant 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.

This medicine may cause serious allergic reactions, including anaphylaxis, 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.

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.

Using too much of this medicine may cause reduced 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 / caffeine / dihydrocodeine 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 / caffeine / dihydrocodeine:

Other side effects

Some side effects of acetaminophen / caffeine / dihydrocodeine 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 / caffeine / dihydrocodeine: oral capsule, oral tablet.

General adverse events

The most frequently expected adverse reactions based on the individual components may include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus and skin reactions.^[Ref]

Hepatic

Acetaminophen:

• Frequency not reported: Hepatotoxicity^[Ref]

Respiratory

Dihydrocodeine:

• Frequency not reported: Respiratory depression, cough suppression^[Ref]

Psychiatric

Dihydrocodeine:

• Frequency not reported: Confusion, physical and psychological dependence, hallucinations vivid dreams

Caffeine:

• Frequency not reported: Anxiety, anxiety neurosis, excitement, insomnia, irritability, restlessness, tenseness^[Ref]

Dermatologic

Dihydrocodeine:

• Frequency not reported: Sweating, pruritus, skin reactions

Acetaminophen:

• Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)

Caffeine:

• Frequency not reported: Urticaria^[Ref]

Hypersensitivity

Dihydrocodeine:

• Frequency not reported: Anaphylactoid reactions, hypersensitivity reactions

Acetaminophen:

• Rare (less than 0.1%): Anaphylactoid reactions
• Frequency not reported: Hypersensitivity reactions including urticarial or erythematous skin reactions, laryngeal edema, angioedema^[Ref]

Nervous system

• Postmarketing reports: Serotonin syndrome

Dihydrocodeine:

• Rare (less than 0.1%): Narcosis
• Frequency not reported: Lightheadedness, dizziness, drowsiness, sedation, headache

Caffeine:

• Frequency not reported: Headaches, lightheadedness, tremor^[Ref]

Renal

Dihydrocodeine:

• Rare (less than 0.1%): Acute renal failure
• Frequency not reported: Granulomatous interstitial nephritis

Caffeine:

• Frequency not reported: Diuresis^[Ref]

Cardiovascular

Dihydrocodeine:

• Frequency not reported: Orthostatic hypotension

Caffeine:

• Frequency not reported: Extrasystoles, palpitations, tachycardia^[Ref]

Endocrine

• Postmarketing reports: Adrenal insufficiency

Opioids:

• Frequency not reported: Androgen deficiency^[Ref]

Chronic opioid use may influence the hypothalamic-pituitary-gonadal axis and lead to androgen deficiency; however, the causal role of opioids is unknown due to the lack of studies into the many medical, physical, lifestyle, and psychological stressors that influence gonadal hormone levels.^[Ref]

Gastrointestinal

Dihydrocodeine:

• Frequency not reported: Nausea, vomiting, constipation, abdominal pain, diarrhea, dry mouth, indigestion, spasm of biliary tract

Caffeine:

• Frequency not reported: Diarrhea, nausea, stomach pain, vomiting^[Ref]

Genitourinary

Dihydrocodeine:

• Frequency not reported: Urinary retention^[Ref]

Hematologic

Acetaminophen:

• Frequency not reported: Thrombocytopenia, leukopenia, pancytopenia, neutropenia, thrombocytopenic purpura, agranulocytosis^[Ref]

Metabolic

Dihydrocodeine:

• Frequency not reported: Anorexia^[Ref]

Ocular

Dihydrocodeine:

• Frequency not reported: Miosis

Caffeine:

• Frequency not reported: Scintillating scotoma^[Ref]

Other

Dihydrocodeine:

• Frequency not reported: Fatigue

Caffeine:

• Frequency not reported: Tinnitus^[Ref]

See also:

Further information

Acetaminophen/caffeine/dihydrocodeine 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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