Acetaminophen / dextromethorphan / guaifenesin / phenylephrine Side Effects

Not all side effects for acetaminophen / dextromethorphan / guaifenesin / phenylephrine 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 / 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:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur while taking acetaminophen / dextromethorphan / guaifenesin / phenylephrine:

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

Cardiovascular side effects of phenylephrine have included palpitations, arrhythmias, and cardiovascular collapse with hypotension.[Ref]

Gastrointestinal

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

General side effects of phenylephrine have included pallor and weakness.[Ref]

Genitourinary

Genitourinary side effects of phenylephrine have included dysuria.[Ref]

Hepatic

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

Hypersensitivity side effects of dextromethorphan have included rare reports of fixed-drug eruptions.[Ref]

Nervous system

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

Psychiatric side effects of phenylephrine have included hallucinations, fear, and anxiety.[Ref]

Respiratory

Respiratory side effects of phenylephrine have included respiratory difficulty.[Ref]

Dermatologic

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]

References

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.

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