Sudafed PE Severe Cold Side Effects
Generic Name: acetaminophen / diphenhydramine / phenylephrine
Note: This page contains side effects data for the generic drug acetaminophen / diphenhydramine / phenylephrine. It is possible that some of the dosage forms included below may not apply to the brand name Sudafed PE Severe Cold.
It is possible that some side effects of Sudafed PE Severe Cold 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 / diphenhydramine / phenylephrine: powder packet, suspension, tablets
Other dosage forms:
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 / diphenhydramine / phenylephrine:
Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mood or mental changes; pale stools; seizures; severe drowsiness; severe or persistent dizziness, nervousness, lightheadedness, or headache; severe or persistent trouble sleeping; stomach pain; tremor; vision changes; yellowing of skin or eyes.
For Healthcare Professionals
Applies to acetaminophen / diphenhydramine / phenylephrine: oral liquid, oral powder for reconstitution, oral syrup, oral tablet
Cardiovascular side effects of acetaminophen have included two cases of hypotension.
Cardiovascular side effects of diphenhydramine have included hypotension, tachycardia, and palpitations.
Cardiovascular side effects of phenylephrine have included palpitations, arrhythmias, and cardiovascular collapse with hypotension.[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]
Dermatologic side effects have included erythematous skin rashes. Acetaminophen associated bullous erythema and purpura fulminans have also been reported. Acetaminophen has been associated with a 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]
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 of acetaminophen have included rare cases of acute pancreatitis.
Gastrointestinal side effects of diphenhydramine have included nausea and dry mouth.
Gastrointestinal side effects of phenylephrine have included nausea.[Ref]
Genitourinary side effects of diphenhydramine have included urinary retention and dysuria.
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.
Hematologic side effects of diphenhydramine have rarely included hemolytic anemia, thrombocytopenia, and agranulocytosis.[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]
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]
Most commonly, hypersensitivity to diphenhydramine has manifested itself in patients receiving systemic drug after being sensitized to it by topical application. Sensitization with systemic administration has also been reported.[Ref]
Hypersensitivity side effects of acetaminophen have included rare reports of anaphylaxis and fixed drug eruptions.
Hypersensitivity side effects to diphenhydramine have included rash, pruritus and eczema. Photosensitivity reactions have also been reported.[Ref]
The CNS depressant effect of diphenhydramine parallels its plasma concentrations. The plasma concentration threshold for sedation is 30 to 42 ng/mL, and to cause mental impairment is 58 to 74 ng/mL. Patients should be warned against driving while taking diphenhydramine.
Dystonic reactions have been accompanied by dizziness, mental confusion, rigidity, lip and tongue protrusion, trismus, torticollis, and swallowing difficulties and generally resolve spontaneously. Toxic encephalopathy has been reported in a child with chicken pox treated generously with topical diphenhydramine.
Delirium has been reported in elderly patients with mild dementia following a small oral dose of diphenhydramine.[Ref]
Nervous system side effects of diphenhydramine have included depression with drowsiness and sedation in nearly all patients treated. Motor skills may be impaired. Dystonic reactions have been reported after single doses of diphenhydramine.
Nervous system side effects of phenylephrine have included headache, dizziness, nervousness, restlessness, tremor, insomnia, convulsions, and central nervous system depression.[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]
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]
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]
1. "Product Information. Sudafed PE Severe Cold (APAP/diphenhydramine/phenylephrine)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
2. Brown G "Acetaminophen-induced hypotension." Heart Lung 25 (1996): 137-40
3. "Product Information. Tylenol Extra Strength PM (acetaminophen-diphenhydramine)." Johnson and Johnson/Merck Consumer, Fort Washington, PA.
4. "Product Information. Ah-Chew D (phenylephrine)." WE Pharmaceuticals Inc, Ramona, CA.
5. Halevi A, BenAmitai D, Garty BZ "Toxic epidermal necrolysis associated with acetaminophen ingestion." Ann Pharmacother 34 (2000): 32-4
6. Lee WM "Medical progress: drug-induced hepatotoxicity." N Engl J Med 333 (1995): 1118-27
7. 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
8. Barranco P, LopezSerrano MC, MorenoAncillo A "Anaphylactic reaction due to diphenhydramine." Allergy 53 (1998): 814
9. 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
10. Richardson GS, Roehrs TA, Rosenthal L, Koshorek G, Roth T "Tolerance to daytime sedative effects of h1 antihistamines." J Clin Psychopharmacol 22 (2002): 511-5
11. Sexton JD, Pronchik DJ "Diphenhydramine induced psychosis with therapeutic doses." Am J Emerg Med 15 (1997): 548-9
12. Eguia L, Materson BJ "Acetaminophen-related acute renal failure without fulminant liver failure." Pharmacotherapy 17 (1997): 363-70
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