Sudafed PE Cold & Cough Side Effects
Generic Name: acetaminophen / dextromethorphan / guaifenesin / phenylephrine
Note: This page contains side effects data for the generic drug acetaminophen / dextromethorphan / guaifenesin / phenylephrine. It is possible that some of the dosage forms included below may not apply to the brand name Sudafed PE Cold & Cough.
It is possible that some side effects of Sudafed PE Cold & Cough 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 / dextromethorphan / guaifenesin / phenylephrine: tablets
Other dosage forms:
Check with your doctor if any of these most COMMON side effects persist or become bothersome: 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 / dextromethorphan / guaifenesin / phenylephrine:
Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.
For Healthcare Professionals
Applies to acetaminophen / dextromethorphan / guaifenesin / phenylephrine: oral liquid, oral powder for reconstitution, oral tablet
Cardiovascular side effects of phenylephrine have included palpitations, arrhythmias, and cardiovascular collapse with hypotension.[Ref]
Gastrointestinal side effects of dextromethorphan have included upset stomach.
Gastrointestinal side effects of guaifenesin have included stomach upset and vomiting with higher than recommended doses. Doses recommended for expectoration have rarely been associated with gastrointestinal upset.
Gastrointestinal side effects of phenylephrine have included nausea.[Ref]
General side effects of phenylephrine have included pallor and weakness.[Ref]
Genitourinary side effects of phenylephrine have included dysuria.[Ref]
Hepatic side effects of acetaminophen have included severe and sometimes fatal dose dependent hepatitis in alcoholic patients. Hepatotoxicity has been increased during fasting.[Ref]
Hypersensitivity side effects of dextromethorphan have included rare reports of fixed-drug eruptions.[Ref]
Nervous system side effects of dextromethorphan have included drowsiness and dizziness. Other side effects such as excitation, mental confusion, and opioid like respiratory depression have been rare and occurred at higher dosages. In some cases of abuse, patients experienced euphoria, hyperactivity, mania, and auditory and visual hallucinations.
Nervous system side effects of guaifenesin have occasionally included dizziness and headache.
Nervous system side effects of phenylephrine have included headache, dizziness, nervousness, restlessness, tremor, insomnia, convulsions, and central nervous system depression.[Ref]
Psychiatric side effects of phenylephrine have included hallucinations, fear, and anxiety.[Ref]
Respiratory side effects of phenylephrine have included respiratory difficulty.[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).
Dermatologic side effects of guaifenesin have included rare reports of rash.[Ref]
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8. McJunkin B, Barwick KW, Little WC, Winfield JB "Fatal massive hepatic necrosis following acetaminophen overdose." JAMA 236 (1976): 1874-5
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10. Kumar S, Rex DK "Failure of physicians to recognize acetaminophen hepatotoxicity in chronic alcoholics." Arch Intern Med 151 (1991): 1189-91
11. Kaysen GA, Pond SM, Roper MH, Menke DJ, Marrama MA "Combined hepatic and renal injury in alcoholics during therapeutic use of acetaminophen." Arch Intern Med 145 (1985): 2019-23
12. Stubb S, Reitamo S "Fixed-drug eruption due to dextromethorphan ." Arch Dermatol 126 (1990): 970-1
13. Polles A, Griffith JL "Dextromethorphan-induced mania." Psychosomatics 37 (1996): 71-4
14. Helfer J, Kim OM "Psychoactive abuse potential of Robitussin-DM." Am J Psychiatry 147 (1990): 672-3
15. Bostwick JM "Dextromethorphan-induced manic symptoms in a bipolar patient on lithium." Psychosomatics 37 (1996): 571-2
16. Hall RC, Beresford TP, Stickney SK, Nasdahl CS, Coleman JH "Psychiatric reactions produced by respiratory drugs." Psychosomatics 26 (1985): 605-8,616-7
17. Murray S, Brewerton T "Abuse of over-the-counter dextromethorphan by teenagers." South Med J 86 (1993): 1151-3
18. "Product Information. Robitussin (guaifenesin)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
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