Flextra-650 Side Effects
Generic Name: acetaminophen / phenyltoloxamine
Note: This page contains information about the side effects of acetaminophen / phenyltoloxamine. Some of the dosage forms included on this document may not apply to the brand name Flextra-650.
Not all side effects for Flextra-650 may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to acetaminophen / phenyltoloxamine: capsules, controlled-release tablets, liquid, tablets
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking acetaminophen / phenyltoloxamine:
Drowsiness; dry mouth, nose, or throat; heartburn; nausea; thickening of mucus in the nose and throat; upset stomach.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dark urine or pale stools; decreased urination; severe stomach pain; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.
For Healthcare Professionals
Applies to acetaminophen / phenyltoloxamine: oral liquid, oral tablet, oral tablet extended release
Hepatic side effects including severe and sometimes fatal dose dependent hepatitis has been reported with the use of acetaminophen 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]
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]
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]
Gastrointestinal side effects including nausea, vomiting, and abdominal pain have been reported frequently with the use of butalbital. Gastrointestinal side effects are rare with acetaminophen use, except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely with the use of acetaminophen.[Ref]
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.
A recent 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.[Ref]
Renal side effects have been rare with the use of acetaminophen and have included 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]
Hypersensitivity side effects, including anaphylaxis and fixed drug eruptions, have been reported rarely in association with acetaminophen use.[Ref]
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.
Hematologic side effects such as hemolytic anemia, thrombocytopenia, and agranulocytosis have been rarely caused by antihistamines.[Ref]
Dermatologic side effects including erythematous skin rashes associated with acetaminophen have been reported, but are rare. Acetaminophen associated bullous erythema and purpura fulminans have also been reported.[Ref]
Respiratory side effects including a case of acetaminophen-induced eosinophilic pneumonia have been reported.[Ref]
Cardiovascular side effects including two cases of hypotension have been reported following the administration of acetaminophen.
Cardiovascular side effects from the use of antihistamines have included hypotension, tachycardia, and palpitations.[Ref]
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]
Metabolic side effects including metabolic acidosis have been reported following a massive overdose of acetaminophen.[Ref]
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]
1. "Product Information. Percogesic (acetaminophen-phenyltoloxamine)." Procter and Gamble Pharmaceuticals, Mason, OH.
2. Gursoy M, Haznedaroglu IC, Celik I, Sayinalp N, Ozcebe OI, Dundar SV "Agranulocytosis, plasmacytosis, and thrombocytosis followed by a leukemoid reaction due to acute acetaminophen toxicity." Ann Pharmacother 30 (1996): 762-5
3. Zimmerman HJ, Maddrey WC "Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure." Hepatology 22 (1995): 767-73
4. Lee WM "Medical progress: drug-induced hepatotoxicity." N Engl J Med 333 (1995): 1118-27
5. Eguia L, Materson BJ "Acetaminophen-related acute renal failure without fulminant liver failure." Pharmacotherapy 17 (1997): 363-70
6. Kawada A, Hiruma M, Noguchi H, Ishibashi A "Fixed drug eruption induced by acetaminophen in a 12-year-old girl." Int J Dermatol 35 (1996): 148-9
7. Halevi A, BenAmitai D, Garty BZ "Toxic epidermal necrolysis associated with acetaminophen ingestion." Ann Pharmacother 34 (2000): 32-4
8. Shoenfeld Y, Shaklai M, Livni E, Pinkhas J "Thrombocytopenia from acetaminophen." N Engl J Med 303 (1980): 47
9. Bougie DW, Benito AI, Sanchez-Abarca LI, Torres R, Birenbaum J, Aster RH "Acute thrombocytopenia caused by sensitivity to the glucuronide conjugate of acetaminophen." Blood 109 (2007): 3608-9
10. Kondo K, Inoue Y, Hamada H, Yokoyama A, Kohno N, Hiwada K "Acetaminophen-induced eosinophilic pneumonia." Chest 104 (1993): 291-2
11. Brown G "Acetaminophen-induced hypotension." Heart Lung 25 (1996): 137-40
12. Koulouris Z, Tierney MG, Jones G "Metabolic acidosis and coma following a severe acetaminophen overdose." Ann Pharmacother 33 (1999): 1191-4
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