Theraflu Cold & Sore Throat Side Effects
Generic Name: acetaminophen / pheniramine / phenylephrine
Note: This page contains side effects data for the generic drug acetaminophen / pheniramine / phenylephrine. It is possible that some of the dosage forms included below may not apply to the brand name Theraflu Cold & Sore Throat.
It is possible that some side effects of Theraflu Cold & Sore Throat may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to acetaminophen / pheniramine / phenylephrine: powder packets
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 / pheniramine / phenylephrine:
Dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; nausea; nervousness; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine or pale stools; difficulty urinating; fast or irregular heartbeat; hallucinations; rapid pulse; seizures; severe or persistent nervousness, dizziness, headache, or trouble sleeping; stomach pain; tremors; unusual fatigue; yellowing of the skin or eyes.
For Healthcare Professionals
Applies to acetaminophen / pheniramine / phenylephrine: oral powder for reconstitution
Cardiovascular side effects of acetaminophen have included two cases of hypotension.
Cardiovascular side effects of phenylephrine have included palpitations, arrhythmias, and cardiovascular collapse with hypotension.[Ref]
Gastrointestinal side effects of acetaminophen have included rare cases of acute pancreatitis.
Gastrointestinal side effects of phenylephrine have included nausea.[Ref]
Genitourinary side effects of phenylephrine have included dysuria.[Ref]
Hematologic side effects of acetaminophen have included rare cases of thrombocytopenia. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.[Ref]
Hepatic side effects of acetaminophen have included severe and sometimes fatal dose dependent hepatitis 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]
Hypersensitivity side effects of acetaminophen have included rare reports of anaphylaxis and fixed drug eruptions.[Ref]
Nervous system side effects of phenylephrine have included headache, dizziness, nervousness, restlessness, tremor, insomnia, convulsions, and central nervous system depression.[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 of acetaminophen 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]
Respiratory side effects of acetaminophen have included a case of eosinophilic pneumonia.
Respiratory side effects of phenylephrine have included respiratory difficulty.[Ref]
Psychiatric side effects of phenylephrine have included hallucinations, fear, and anxiety.[Ref]
General side effects of phenylephrine have included pallor and weakness.[Ref]
Dermatologic side effects associated with acetaminophen includes the risk of rare but potentially fatal serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).[Ref]
1. "Product Information. Ah-Chew D (phenylephrine)." WE Pharmaceuticals Inc, Ramona, CA.
2. Brown G "Acetaminophen-induced hypotension." Heart Lung 25 (1996): 137-40
3. 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
4. Lee WM "Medical progress: drug-induced hepatotoxicity." N Engl J Med 333 (1995): 1118-27
5. 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
6. Halevi A, BenAmitai D, Garty BZ "Toxic epidermal necrolysis associated with acetaminophen ingestion." Ann Pharmacother 34 (2000): 32-4
7. Eguia L, Materson BJ "Acetaminophen-related acute renal failure without fulminant liver failure." Pharmacotherapy 17 (1997): 363-70
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