Chlorpheniramine / codeine / pseudoephedrine Side Effects

Not all side effects for chlorpheniramine / codeine / pseudoephedrine 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 chlorpheniramine / codeine / pseudoephedrine: liquid

Other dosage forms:

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

Constipation; dizziness; drowsiness; dry mouth, throat, or nose; excitement; nausea; stomach upset; thickening or mucus in nose or throat; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; flushing or redness of face; severe drowsiness; trouble breathing; vision changes.

For Healthcare Professionals

Applies to chlorpheniramine / codeine / pseudoephedrine: oral elixir, oral liquid

Nervous system

Nearly all patients treated with chlorpheniramine experience drowsiness. This drowsiness may subside in some patients with extended use. Patients should be warned against driving, as well as concomitant ingestion of alcohol and other sedative-hypnotic drugs, while taking chlorpheniramine.

Few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of chlorpheniramine extended over a period of 3 to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms.

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]

Central nervous system side effects of chlorpheniramine have included CNS depression which commonly occurs with chlorpheniramine administration, resulting in drowsiness in 75% or greater of treated patients. Dyskinesias have rarely been reported following chronic use of chlorpheniramine. 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 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

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 (simulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.[Ref]

Cardiovascular side effects of chlorpheniramine have included hypotension, tachycardia, and palpitations. 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]

Gastrointestinal

Gastrointestinal side effects of chlorpheniramine have included dry mouth and constipation due to its anticholinergic effect. This may occur in up to one-third of treated patients. 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 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 chlorpheniramine have included dysuria, urinary hesitancy, and a decrease in urine flow. In rare cases, the anticholinergic effect of chlorpheniramine may precipitate acute urinary retention. Genitourinary side effects of codeine have included urinary retention.[Ref]

Ocular

Ocular effects of chlorpheniramine have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.[Ref]

Hematologic

Hematologic adverse effects of chlorpheniramine have included bone marrow suppression, thrombocytopenia, and aplastic anemia.[Ref]

A fatal case of agranulocytosis has been reported in a patient taking chlorpheniramine, pseudoephedrine, acetaminophen, dextromethorphan, phenylpropanolamine, and aspirin. Chlorpheniramine was felt to be the cause.[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.[Ref]

Renal

Acute renal failure (which may respond to naloxone therapy) has been reported in association with codeine 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]

General

The adverse effects of codeine may be more likely and more severe in patients with liver and renal disease.[Ref]

References

1. 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

2. Thomas JS, Heurich AE, Ralph JW, Crane R, Shepherd DA "Double-blind, controlled study of clemastine fumarate, chlorpheniramine and placebo in patients with seasonal allergic rhinitis." Ann Allergy 38 (1977): 169-74

3. 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

4. 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

5. Thach BT, Chase TN, Bosma JF "Oral facial dyskinesia associated with prolonged use of antihistaminic decongestants." N Engl J Med 293 (1975): 486-7

6. Schuller DE, Turkewitz D "Adverse effects of antihistamines." Postgrad Med 79 (1986): 75-86

7. Bantz EW, Dolen WK, Chadwick EW, Nelson HS "Chronic chlorpheniramine therapy: subsensitivity, drug metabolism, and compliance." Ann Allergy 59 (1987): 341-6

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

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

10. 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

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

12. 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

13. Malek-Ahmadi P, Ramsey ML "Acute psychosis associated with codeine and acetaminophen: a case report." Neurobehav Toxicol Teratol 7 (1985): 193-4

14. "Product Information. Ryna-C Liquid (chlorpheniramine-pseudoephedrine)" Wallace Laboratories, Cranbury, NJ.

15. Krause LB, Shuster S "A comparison of astemizole and chlorpheniramine in dermographic urticaria." Br J Dermatol 112 (1985): 447-53

16. 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

17. 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

18. Weiler JM, Donnelly A, Campbell BH, Connell JT, Diamond L, Hamilton LH, Rosenthal RR, Hemsworth GR, Perhach JL, Jr "Multicenter, double-blind, multiple-dose, parallel-groups efficacy and safety trial of azelastine, chlorpheniramine, and placebo in the treatment of spring allergic rhinitis." J Allergy Clin Immunol 82 (1988): 801-11

19. "Letter: Dyskinesia associated with chronic antihistamine use." N Engl J Med 294 (1976): 113

20. Millet VM, Dreisbach M, Bryson YJ "Double-blind controlled study of central nervous system side effects of amantadine, rimantadine, and chlorpheniramine." Antimicrob Agents Chemother 21 (1982): 1-4

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

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

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

24. 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

25. 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

26. 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

27. 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

28. 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

29. "Product Information. Chlortrimeton (chlorpheniramine)." Schering-Plough, Liberty Corner, NJ.

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

31. 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

32. 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

33. Kanoh T, Jingami H, Uchino H "Aplastic anaemia after prolonged treatment with chlorpheniramine ." Lancet 1 (1977): 546-7

34. Eisner EV, LaBocki NL, Pinckney L "Chlorpheniramine-dependent thrombocytopenia." JAMA 231 (1975): 735-6

35. Hardin AS "Chlorpheniramine and agranulocytosis ." Ann Intern Med 108 (1988): 770

36. Deringer PM, Maniatis A "Chlorpheniramine-induced bone-marrow suppression." Lancet 1 (1976): 432

37. 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

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

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

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

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

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

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

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

45. 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

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

47. "Multum Information Services, Inc. Expert Review Panel"

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