Panadol Side Effects

Generic name: acetaminophen

Note: This document contains side effect information about acetaminophen. Some of the dosage forms listed on this page may not apply to the brand name Panadol.

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

For the Consumer

Applies to acetaminophen: oral capsule, oral granule effervescent, oral liquid, oral suspension, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking acetaminophen (the active ingredient contained in Panadol) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and call your doctor at once if you have a serious side effect such as:

• nausea, upper stomach pain, itching, loss of appetite;

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to acetaminophen: compounding powder, intravenous solution, oral capsule, oral granule effervescent, oral liquid, oral powder for reconstitution, oral suspension, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release, rectal suppository

General

In general, acetaminophen (the active ingredient contained in Panadol) is well-tolerated when administered in therapeutic doses.

Hepatic

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen (the active ingredient contained in Panadol) 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.

Hepatic side effects 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.

Gastrointestinal

Gastrointestinal side effects have included nausea (34%) and vomiting (15%). Cases of acute pancreatitis have been reported rarely.

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.

Renal

Renal side effects 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.

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.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis and fixed drug eruptions have been reported rarely in association with acetaminophen (the active ingredient contained in Panadol) use.

Hematologic

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen (the active ingredient contained in Panadol) 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 been observed in the setting of acute overdose.

Dermatologic

Dermatologic side effects including erythematous skin rashes associated with acetaminophen (the active ingredient contained in Panadol) 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. Dermatologic side effects associated with IV acetaminophen have included infusion site pain and peripheral edema.

Respiratory

Respiratory side effects have included dyspnea and a case of acetaminophen-induced eosinophilic pneumonia.

Cardiovascular

Two cases hypotension have been reported following the administration of acetaminophen (the active ingredient contained in Panadol) 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.

Cardiovascular side effects including hypertension and hypotension have been reported following the administration of acetaminophen.

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 (the active ingredient contained in Panadol) 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.

Metabolic side effects have included hypokalemia. Metabolic side effects including metabolic acidosis have been reported following a massive overdose of acetaminophen.

Nervous system

Nervous system side effects associated with IV acetaminophen (the active ingredient contained in Panadol) have included headache (10%), insomnia (7%), and fatigue.

Musculoskeletal

Musculoskeletal side effects associated with acetaminophen (the active ingredient contained in Panadol) IV have included muscle spasms and trismus.

Psychiatric

Psychiatric side effects associated with acetaminophen (the active ingredient contained in Panadol) IV have included anxiety.

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