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:
Seek medical attention right away if any of these SEVERE side effects occur while taking acetaminophen / dextromethorphan / guaifenesin / phenylephrine:
Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; nervousness; trouble sleeping; upset stomach.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; redness; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe or persistent nervousness or trouble sleeping; shortness of breath; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); tremor; trouble urinating or inability to urinate; vision changes.
For Healthcare Professionals
Applies to acetaminophen / dextromethorphan / guaifenesin / phenylephrine: oral capsule, 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]
1. "Product Information. Lusonal (phenylephrine)." Wraser Pharmaceuticals, Ridgeland, MS.
2. Knowles SR, Weber E "Dextromethorphan anaphylaxis." J Allerg Clin Immunol 102 (1998): 316-7
3. Wolfe TR, Caravati EM "Massive dextromethorphan ingestion and abuse." Am J Emerg Med 13 (1995): 174-6
4. Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):
5. O'Dell JR, Zetterman RK, Burnett DA "Centrilobular hepatic fibrosis following acetaminophen-induced hepatic necrosis in an alcoholic." JAMA 255 (1986): 2636-7
6. Keaton MR "Acute renal failure in an alcoholic during therapeutic acetaminophen ingestion." South Med J 81 (1988): 1163-6
7. Seeff LB, Cuccherini BA, Zimmerman HJ, Adler E, Benjamin SB "Acetaminophen hepatotoxicity in alcoholics." Ann Intern Med 104 (1986): 399-404
8. 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
9. McJunkin B, Barwick KW, Little WC, Winfield JB "Fatal massive hepatic necrosis following acetaminophen overdose." JAMA 236 (1976): 1874-5
10. Zimmerman HJ, Maddrey WC "Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure." Hepatology 22 (1995): 767-73
11. Kumar S, Rex DK "Failure of physicians to recognize acetaminophen hepatotoxicity in chronic alcoholics." Arch Intern Med 151 (1991): 1189-91
12. Stubb S, Reitamo S "Fixed-drug eruption due to dextromethorphan ." Arch Dermatol 126 (1990): 970-1
13. Helfer J, Kim OM "Psychoactive abuse potential of Robitussin-DM." Am J Psychiatry 147 (1990): 672-3
14. Bostwick JM "Dextromethorphan-induced manic symptoms in a bipolar patient on lithium." Psychosomatics 37 (1996): 571-2
15. Polles A, Griffith JL "Dextromethorphan-induced mania." Psychosomatics 37 (1996): 71-4
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.
More about Sudafed PE Cold & Cough (acetaminophen / dextromethorphan / guaifenesin / phenylephrine)
- Other brands: Vicks DayQuil Severe Cold & Flu, Tylenol Cold & Flu Severe, Mucinex Fast-Max Severe Congestion & Cold, Tylenol Cold Multi-Symptom Severe, More (9) »
Related treatment guides
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.