Acetaminophen and Aspirin (Buffered)

Name: Acetaminophen and Aspirin (Buffered)

What are some things I need to know or do while I take Acetaminophen and Aspirin?

  • Tell all of your health care providers that you take acetaminophen and aspirin. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid other sources of acetaminophen. Check labels closely. Too much acetaminophen may cause problems.
  • This medicine has acetaminophen in it. Very bad and sometimes deadly liver problems like the need for a liver transplant have happened with acetaminophen use. Most of the time, liver problems have happened in people taking more than 4,000 milligrams of acetaminophen in a day. Also, people who had liver problems were often using more than 1 drug that had acetaminophen in it. Talk with your doctor.
  • Call your doctor right away if you take more than 4,000 mg (milligrams) of acetaminophen in a day, even if you feel well.
  • Talk with your doctor before you drink alcohol.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye's syndrome. Reye's syndrome causes very bad problems to the brain and liver.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Acetaminophen and Aspirin) best taken?

Use acetaminophen and aspirin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take tablet with or without food. Take with food if it causes an upset stomach.
  • Take with a full glass of water.

What do I do if I miss a dose?

  • This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

How do I store and/or throw out Acetaminophen and Aspirin?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • 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.

This information should not be used to decide whether or not to take acetaminophen and aspirin or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to acetaminophen and aspirin. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Feeling confused.
  • Feeling very tired or weak.
  • Very bad belly pain.
  • Ringing in ears.
  • Hearing loss.
  • Very bad headache or if headache is not better after the first dose.
  • Pain for more than 10 days.
  • Fever for more than 3 days.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

For Healthcare Professionals

Applies to acetaminophen / aspirin: oral tablet

Cardiovascular

Cardiovascular side effects of aspirin have included salicylate- induced variant angina, ventricular ectopy, conduction abnormalities, and hypotension, particularly during salicylate toxicity. In addition, at least one case of fluid retention simulating acute congestive heart failure has been reported during aspirin therapy.

Cardiovascular side effects including two cases of hypotension have been reported following the administration of acetaminophen.[Ref]

A 29- year- old female with a history of migraine developed chest pain, tachycardia and orthopnea following aspirin consumption at doses of 1500 mg per day for several days. After discontinuation of aspirin therapy, the patient's symptoms promptly resolved. The patient consented to a pharmacological challenge test which once again triggered the symptoms.

Two cases hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.[Ref]

Dermatologic

Dermatologic side effects of aspirin have included Stevens-Johnson syndrome and a lichenoid eruption.

Dermatologic side effects including erythematous skin rashes associated with acetaminophen have been reported, but are rare. Acetaminophen associated bullous erythema and purpura fulminans have been reported. One case of toxic epidermal necrolysis associated with acetaminophen administered to a pediatric patient has been reported. Acetaminophen has also been associated with a risk of rare but potentially fatal serious skin reactions know as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).[Ref]

Endocrine

Endocrine side effects of aspirin have included hypoglycemia (which has been reported in children) and hyperglycemia.[Ref]

Gastrointestinal

Gastrointestinal side effects of aspirin have included epigastric distress (in as many as 83% of patients treated with regular aspirin), abdominal discomfort or pain, endoscopically identifiable gastric mucosal lesions, nausea, and vomiting. More serious gastrointestinal effects include hemorrhage, peptic ulcers, perforation, and esophageal ulcerations.

Gastrointestinal side effects of acetaminophen are rare except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely.[Ref]

Endoscopically identifiable gastric mucosal lesions occur in most patients who receive a single dose of aspirin. Clinically evident gastrointestinal bleeding has been reported in as many as 3% of treated elderly patients. Anorectal ulceration and rectal stenosis have been reported in patients who abuse aspirin- containing rectal suppositories. One case- controlled study has suggested that an association between aspirin (and other NSAID) consumption and appendicitis may exist.

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.[Ref]

General

In general, acetaminophen is well- tolerated when administered in therapeutic doses.[Ref]

Hematologic

Hematologic side effects of aspirin have included increased blood fibrinolytic activity. In addition, hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, and pancytopenia have been reported rarely. Aplastic anemia and eosinophilia have also been reported.

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported. Acute thrombocytopenia has also been reported as having been caused by sensitivity to acetaminophen glucuronide, the major metabolite of acetaminophen. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.[Ref]

Hepatic

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19-year-old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.[Ref]

Hepatic side effects of aspirin have included hepatotoxicity and cholestatic hepatitis.

Hepatic side effects of acetaminophen including severe and sometimes fatal dose dependent hepatitis have been reported in alcoholic patients. Hepatotoxicity has been increased during fasting. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity.[Ref]

Hypersensitivity

Hypersensitivity side effects of aspirin have included bronchospasm, rhinitis, conjunctivitis, urticaria, angioedema, and anaphylaxis. Approximately 10% to 30% of asthmatics are aspirin- sensitive (with the clinical triad of aspirin sensitivity, bronchial asthma, and nasal polyps).

Hypersensitivity side effects including anaphylaxis and fixed drug eruptions have been reported rarely in association with acetaminophen use.[Ref]

The mechanism of aspirin- induced hypersensitivity may be related to an up- regulation of the 5- lipoxygenase pathway of arachidonic acid metabolism with a resulting increase in the products of 5- lipoxygenase (such as leukotrienes).[Ref]

Metabolic

In the case of metabolic acidosis, causality is uncertain as more than one drug was ingested. The case of metabolic acidosis followed the ingestion of 75 grams of acetaminophen, 1.95 grams of aspirin, and a small amount of a liquid household cleaner. The patient also had a history of seizures which the authors reported may have contributed to an increased lactate level indicative of metabolic acidosis.[Ref]

Metabolic side effects of aspirin have included dehydration and hyperkalemia. Respiratory alkalosis and metabolic acidosis, particularly during salicylate toxicity, have been reported. A case of hypoglycemia has been reported in a patient on hemodialysis. Salicylates have also been reported to displace triiodothyronine (T3) and thyroxine (T4) from protein binding sites. The initial effect is an increase in serum free T4 concentrations.

Metabolic side effects including metabolic acidosis have been reported following a massive overdose of acetaminophen.[Ref]

Musculoskeletal

Musculoskeletal side effects of aspirin have included rhabdomyolysis.[Ref]

Nervous system

Central nervous system side effects of aspirin have included agitation, cerebral edema, coma, confusion, dizziness, headache, cranial hemorrhage, lethargy and seizures. Tinnitus and subjective hearing loss (or both) may occur. Some investigators have reported that modest doses may result in decreased frequency selectivity and may therefore impair hearing performance, particularly in the setting of background noise.[Ref]

Some investigators have suggested that tinnitus may be a less reliable indicator of salicylate toxicity than previously believed. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In a study of rheumatoid arthritis patients, those with tinnitus had no greater salicylate levels than those without tinnitus. Elderly patients may be less likely to perceive tinnitus than younger patients.[Ref]

Ocular

Ocular side effects of aspirin have included cases of localized periorbital edema.[Ref]

Oncologic

Oncologic side effects of aspirin have included reports of pancreatic cancer. Several epidemiologic studies have suggested that chronic aspirin use may decrease the risk of large bowel neoplasms. However, other studies have not found such a beneficial effect.[Ref]

Other

Other side effects of aspirin have included Reye's syndrome with use in children with an acute viral illness. Reye's syndrome has also been reported even more rarely in adults.[Ref]

Reye's syndrome, following use of aspirin, typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.[Ref]

Renal

The mechanism of an aspirin- induced decrease in renal function may be related to inhibition of renal prostaglandin synthesis with consequent decreases in renal blood flow. Vasodilating renal prostaglandins may be particularly important in patients who exhibit arterial underfilling (i.e., heart failure, cirrhosis). The administration of high doses of NSAIDs to such patients has produced acute renal failure in rare instances.

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

One case-control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease particularly in patients taking more than two pills per day.

However, a recent cohort study of analgesia use of initially healthy men concluded that moderate use of analgesics including acetaminophen was not associated with increased risk of renal disease.[Ref]

Renal side effects of aspirin have included reduction in glomerular filtration rate (particularly in patients who are sodium restricted or who exhibit diminished effective arterial blood volume, such as patients with advanced heart failure or cirrhosis), interstitial nephritis, papillary necrosis, elevations in serum creatinine, elevations in blood urea nitrogen, proteinuria, hematuria, and renal failure.

Renal side effects of acetaminophen are rare and have included acute renal failure, acute tubular necrosis, and interstitial nephritis. Adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen- related hepatotoxicity.[Ref]

Respiratory

Respiratory side effects of aspirin have included hyperpnea, pulmonary edema, and tachypnea.

Respiratory side effects including a case of acetaminophen- induced eosinophilic pneumonia have been reported.[Ref]

Aspirin desensitization has been used to decrease disease activity and reduce the need for systemic corticosteroids in patients with aspirin- exacerbated respiratory disease.[Ref]

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

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