Maxifed CDX Side Effects

Generic Name: codeine / guaifenesin / pseudoephedrine

Note: This page contains information about the side effects of codeine / guaifenesin / pseudoephedrine. Some of the dosage forms included on this document may not apply to the brand name Maxifed CDX.

Not all side effects for Maxifed CDX 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 codeine / guaifenesin / pseudoephedrine: liquid, solution, suspension, syrup, tablets

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur while taking codeine / guaifenesin / pseudoephedrine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; persistent trouble sleeping; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.

For Healthcare Professionals

Applies to codeine / guaifenesin / pseudoephedrine: oral liquid, oral tablet

General

Guaifenesin is generally well tolerated.[Ref]

Nervous system

Opioids may result in psychotic symptoms in some patients.

One retrospective study of elderly patients who sustained a hip fracture suggested that the relative risk of hip fracture was 1.6 in patients using codeine compared to age-matched non-users.[Ref]

Nervous system side effects of codeine have included mental and respiratory depression, stupor, delirium, somnolence, and dysphoria. An increased risk of falls and hip fractures has been associated with codeine therapy, particularly in the elderly. Nervous system side effects of guaifenesin have included dizziness and headache. Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.[Ref]

Other

Other side effects of codeine have included withdrawal symptoms after either abrupt cessation or fast tapering of narcotic analgesics, including codeine, and have included agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting and sweating.[Ref]

Cardiovascular

Cardiovascular adverse effects of codeine have included hypotension and dizziness. Cardiovascular side effects of pseudoephedrine have included tachycardia. Some patients have developed hypertension and/or arrhythmias.[Ref]

Hypotension is rare and has been reported most frequently with high doses of codeine.

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.

One report evaluated the effect with 60 mg of pseudoephedrine on individuals in a hyperbaric chamber at 1 atmosphere (simulated scuba dive to 66 feet of sea water). Pseudoephedrine and depth (stimulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.[Ref]

Gastrointestinal

Gastrointestinal side effects of codeine have included nausea, vomiting, and constipation. Severe constipation and ileus resulting in colonic perforation have also been reported. Four cases of acute pancreatitis have been reported. Gastrointestinal side effects of guaifenesin have included upset stomach and vomiting with higher than recommended doses. Doses recommended for expectoration are rarely associated with gastrointestinal upset. Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients.[Ref]

Genitourinary

Genitourinary side effects of codeine have included urinary retention.[Ref]

Hypersensitivity

Hypersensitivity side effects of pseudoephedrine have included fixed drug eruptions.[Ref]

Dermatologic

Dermatologic side effects of codeine have included rash. Codeine-induced rash may be related to direct stimulation of histamine release. There are also case reports of severe scarlatiniform eruptions. Dermatologic side effects of guaifenesin have also included rash.[Ref]

Renal

Renal side effects of codeine have included acute renal failure (which may respond to naloxone therapy).[Ref]

Immunologic

Immunologic side effects of codeine have included one study of a patient with exercise-induced anaphylaxis and three control subjects. This study found a correlation between codeine wheal size and recent exercise.[Ref]

References

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4. Dickerson J, Perrier D, Mayersohn M, Bressler R "Dose tolerance and pharmacokinetic studies of L (+) pseudoephedrine capsules in man." Eur J Clin Pharmacol 14 (1978): 253-9

5. Loizou LA, Hamilton JG, Tsementzis SA "Intracranial haemorrhage in association with pseudoephedrine overdose." J Neurol Neurosurg Psychiatry 45 (1982): 471-2

6. Cox RG "Hypoxaemia and hypotension after intravenous codeine phosphate." Can J Anaesth 41 (1994): 1211-3

7. Redpath JB, Pleuvry BJ "Double-blind comparison of the respiratory and sedative effects of codeine phosphate and (+/-)-glaucine phosphate in human volunteers." Br J Clin Pharmacol 14 (1982): 555-8

8. "Product Information. Robitussin (guaifenesin)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

9. Max MB, Schafer SC, Culnane M, et al "Association of pain relief with drug side effects in postherpeticneuralgia: a single-dose study of clonidine, codeine, ibuprofen, and placebo." Clin Pharmacol Ther 43 (1988): 363-71

10. Stambaugh JE Jr, McAdams J "Comparison of the analgesic efficacy and safety of oral ciramadol, codeine, and placebo in patients with chronic cancer pain." J Clin Pharmacol 27 (1987): 162-6

11. Lyon CC, Turney JH "Pseudoephedrine toxicity in renal failure." Br J Clin Pract 50 (1996): 396-7

12. Stroh JE, Jr Ayars GH, Bernstein IL, Kemp JP, Podleski WK, Prenner BM, Schoenwetter WF, Salzmann JK "A comparative tolerance study of terfenadine-pseudoephedrine combination tablets and pseudoephedrine tablets in patients with allergic or vasomotor rhinitis." J Int Med Res 16 (1988): 420-7

13. Bradley CM, Nicholson AN "Effects of a mu-opoiod receptor agonist (codeine phosphate) on visuo-motor coordination and dynamic visual acuity in man." Br J Clin Pharmacol 22 (1986): 507-12

14. de Groot AC, Conemans J "Allergic urticarial rash from oral codeine." Contact Dermatitis 14 (1986): 209-14

15. Shorr RI, Griffin MR, Daugherty JR, Ray WA "Opioid analgesics and the risk of hip fracture in the elderly: codeine and propoxyphene." J Gerontol 47 (1992): m111-5

16. "Product Information. Calcidrine (codeine)." Abbott Pharmaceutical, Abbott Park, IL.

17. Rosen RA "Angina associated with pseudoephedrine ." Ann Emerg Med 10 (1981): 230-1

18. Gill ND, Shield A, Blazevich AJ, Zhou S, Weatherby RP "Muscular and cardiorespiratory effects of pseudoephedrine in human athletes." Br J Clin Pharmacol 50 (2000): 205-13

19. Mariani PJ "Pseudoephedrine-induced hypertensive emergency: treatment with labetalol." Am J Emerg Med 4 (1986): 141-2

20. Wiener I, Tilkian AG, Palazzolo M "Coronary artery spasm and myocardial infarction in a patient with normal coronary arteries: temporal relationship to pseudoephedrine ingestion." Cathet Cardiovasc Diagn 20 (1990): 51-3

21. Matske GR, Chan GL, Abraham PA "Codeine dosage in renal failure." Clin Pharm 5 (1986): 15-6

22. Taylor DM, O'Toole KS, Auble TE, Ryan CM, Sherman DR "The psychometric and cardiac effects of pseudoephedrine in the hyperbaric environment." Pharmacotherapy 20 (2000): 1045-50

23. Parke TJ, Nandi PR, Bird KJ, Jewkes DA "Profound hypotension following intravenous codeine phosphate: three case reports and some recommendations." Anaesthesia 47 (1992): 852-4

24. Gordon RD, Ballantine DM, Bachmann AW "Effects of repeated doses of pseudoephedrine on blood pressure and plasma catecholamines in normal subjects and in patients with phaeochromocytoma." Clin Exp Pharmacol Physiol 19 (1992): 287-90

25. "Product Information. Robitussin-DAC Syrup (codeine/guaifenesin/PSE)" Whitehall-Robins, Madison, NJ.

26. Mores N, Campia U, Navarra P, Cardillo C, Preziosi P "No cardiovascular effects of single-dose pseudoephedrine in patients with essential hypertension treated with beta-blockers." Eur J Clin Pharmacol 55 (1999): 251-4

27. Dowd J, Bailey D, Moussa K, Nair S, Doyle R, CulpepperMorgan JA "Ischemic colitis associated with pseudoephedrine: Four cases." Am J Gastroenterol 94 (1999): 2430-4

28. Hastier P, Buckley MJM, Peten EP, Demuth N, Dumas R, Demarquay JF, CaroliBosc FX, Delmont JP "A new source of drug-induced acute pancreatitis: Codeine." Am J Gastroenterol 95 (2000): 3295-8

29. Tomb RR, Lepoittevin JP, Espinassouze F, Heid E, Foussereau J "Systemic contact dermatitis from pseudoephedrine." Contact Dermatitis 24 (1991): 86-8

30. Vidal C, Prieto A, PerezCarral C, Armisen M "Nonpigmenting fixed drug eruption due to pseudoephedrine." Ann Allergy Asthma Immunol 80 (1998): 309-10

31. Quan MB, Chow WC "Nonpigmenting fixed drug eruption after pseudoephedrine." Int J Dermatol 35 (1996): 367-70

32. Shelley WB, Shelley ED "Nonpigmenting fixed drug eruption as a distinctive reaction pattern: examples caused by sensitivity to pseudoephedrine hydrochloride and tetrahydrozoline." J Am Acad Dermatol 17 (1987): 403-7

33. Camisa C "Fixed drug eruption due to pseudoephedrine." Cutis 41 (1988): 339-40

34. Gonzalogarijo MA, Revengaarranz F "Fixed drug eruption due to codeine." Br J Dermatol 135 (1996): 498-9

35. Hunskaar S, Dragsund S "Scarlatiniform rash and urticaria due to codeine." Ann Allergy 54 (1985): 240-1

36. Barnes JN, Williams AJ, Tomson MJ, et al "Dihydrocodeine in renal failure: further evidence for an important role of the kidney in the handling of opioid drugs." Br Med J (Clin Res Ed) 290 (1985): 740-2

37. Park GR, Shelly MP, Quinn K, Roberts P "Dihydrocodeine: a reversible cause of renal failure?" Eur J Anaesthesiol 6 (1989): 303-14

38. Hill SA, Quinn K, Shelly MP, Park GR "Reversible renal failure following opioid administration." Anaesthesia 46 (1991): 938-9

39. Lin RY, Barnard M "Skin testing with food, codeine, and histamine in exercise-induced anaphylaxis." Ann Allergy 70 (1993): 475-8

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