Sudodrin Side Effects

Generic Name: pseudoephedrine

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

It is possible that some side effects of Sudodrin 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 pseudoephedrine: oral capsule, oral capsule extended release, oral capsule liquid filled, oral liquid, oral solution, oral suspension, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

As well as its needed effects, pseudoephedrine (the active ingredient contained in Sudodrin) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking pseudoephedrine, check with your doctor or nurse as soon as possible:

Rare - more common with high doses
  • Convulsions (seizures)
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • irregular or slow heartbeat
  • shortness of breath or troubled breathing
Symptoms of overdose
  • Convulsions (seizures)
  • fast breathing
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • increase in blood pressure
  • irregular heartbeat (continuing)
  • shortness of breath or troubled breathing (severe or continuing)
  • slow or fast heartbeat (severe or continuing)
  • unusual nervousness, restlessness, or excitement

Some pseudoephedrine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Nervousness
  • restlessness
  • trouble in sleeping
Less common
  • Difficult or painful urination
  • dizziness or light-headedness
  • fast or pounding heartbeat
  • headache
  • increased sweating
  • nausea or vomiting
  • trembling
  • unusual paleness
  • weakness

For Healthcare Professionals

Applies to pseudoephedrine: compounding powder, oral liquid, oral suspension extended release, oral tablet, oral tablet chewable, oral tablet extended release

Cardiovascular

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 (the active ingredient contained in Sudodrin) 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 have included tachycardia. Some patients have developed hypertension and/or arrhythmias.[Ref]

Nervous system

Nervous system side effects have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects 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]

Hypersensitivity

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

Other

False-positive amphetamine immunoassay have resulted from pseudoephedrine (the active ingredient contained in Sudodrin) False-positives can occur far below the published pseudoephedrine threshold, indicating that cross-reactivity in human specimens is sometimes greater than the limits reported.[Ref]

References

1. 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

2. 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

3. 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

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

6. 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

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

8. 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

9. 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

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

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

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

13. 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

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

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

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

17. 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

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

19. Depriest AZ, Knight JL, Doering PL, Black DL "Pseudoephedrine and false-positive immunoassay urine drug tests for amphetamine." Pharmacotherapy (2012):

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