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Novahistine Expectorant Side Effects

Generic Name: codeine / guaifenesin / pseudoephedrine

Note: This page contains side effects data for the generic drug codeine / guaifenesin / pseudoephedrine. It is possible that some of the dosage forms included below may not apply to the brand name Novahistine Expectorant.

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, light-headedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.

For Healthcare Professionals

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

General

The more commonly expected adverse effects include nausea, vomiting, and dizziness.[Ref]

Nervous system

Codeine
Frequency not reported: CNS depression, lightheadedness, dizziness, sedation, headache, convulsions, weakness

Pseudoephedrine:
Frequency not reported: Restlessness, dizziness, weakness, headache, drowsiness, tremor[Ref]

Cardiovascular

Codeine
Frequency not reported: Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension, circulatory depression

Pseudoephedrine:
Frequency not reported: Tachycardia, palpitations, cardiac arrhythmias, hypertension, impaired circulation to the extremities, coronary artery spasm, chest pain[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.[Ref]

Gastrointestinal

Codeine
Frequency not reported: Nausea, vomiting, constipation, biliary tract spasm, increased colonic motility, toxic dilation

Guaifenesin:
Frequency not reported: Abdominal pain (upper), diarrhea, nausea, vomiting

Pseudoephedrine:
Frequency not reported: Nausea, vomiting, dry mouth, ischemic colitis[Ref]

Patients with chronic ulcerative colitis may experience increased colonic motility, while patients with acute ulcerative colitis have experienced toxic dilation with codeine use.[Ref]

Genitourinary

Codeine
Frequency not reported: Oliguria, urinary retention, antidiuretic effect

Pseudoephedrine:
Frequency not reported: Urinary retention[Ref]

Hypersensitivity

Codeine
Frequency not reported: Pruritus, giant urticaria, angioneurotic edema, laryngeal edema

Guaifenesin:
Frequency not reported: Hypersensitivity reactions (pruritus, urticaria)

Pseudoephedrine:
Frequency not reported: Fixed drug eruptions[Ref]

Dermatologic

Codeine:
Frequency not reported: Rash

Guaifenesin:
Frequency not reported: Rash

Pseudoephedrine:
Frequency not reported: Fixed drug eruption in the form of erythematous nodular patches, rash[Ref]

Ocular

Codeine
Frequency not reported: Visual disturbances

Pseudoephedrine:
Frequency not reported: Angle-closure glaucoma

Psychiatric

Codeine
Frequency not reported: Euphoria, dysphoria, transient hallucination, disorientation

Pseudoephedrine:
Frequency not reported: Hallucinations (particularly in children), anxiety, excitability, insomnia

Respiratory

Respiratory depression has been associated with antitussive use of codeine in young children. Respiratory depression and death have occurred in children who received codeine in the postoperative period following tonsillectomy and/or adenoidectomy. Further investigation has shown these patients to be ultra-rapid metabolizers of codeine. Children with obstructive sleep apnea who are treated with codeine appear to be particularly sensitive to the respiratory depressant effects of codeine.

Codeine:
Frequency not reported: Respiratory depression

References

1. Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):

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

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

4. 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

5. 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

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

7. 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

8. 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

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

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

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

12. 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

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

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

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

It is possible that some side effects of Novahistine Expectorant may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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