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Acrivastine / pseudoephedrine Side Effects

In Summary

Commonly reported side effects of acrivastine/pseudoephedrine include: dizziness and drowsiness. Other side effects include: insomnia, sedation, and xerostomia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to acrivastine / pseudoephedrine: oral capsule

In addition to its needed effects, some unwanted effects may be caused by acrivastine / pseudoephedrine. In the event that any of these side effects do occur, they may require medical attention.

If any of the following symptoms of overdose occur while taking acrivastine / pseudoephedrine, get emergency help immediately:

Symptoms of overdose:
  • Blurred vision
  • chest pain or discomfort
  • cold, clammy, or pale skin
  • confusion
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • irregular heartbeats
  • seizures
  • shortness of breath
  • slow heart rate
  • sweating
  • unusual tiredness or weakness

Minor Side Effects

Some of the side effects that can occur with acrivastine / pseudoephedrine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Dry mouth
  • headache
  • sleepiness or unusual drowsiness
Less common:
  • Acid or sour stomach
  • belching
  • body aches or pain
  • congestion
  • cough
  • dryness or soreness of the throat
  • fever
  • heartburn
  • hoarseness
  • indigestion
  • lack or loss of strength
  • nausea
  • nervousness
  • runny nose
  • stomach discomfort, upset, or pain
  • tender, swollen glands in the neck
  • trouble sleeping
  • trouble swallowing
  • voice changes

For Healthcare Professionals

Applies to acrivastine / pseudoephedrine: oral capsule

Nervous system

Although acrivastine has little effect on the central nervous system, a reduction in motor skills when taken with alcohol has been seen in at least one study. Patients should be warned not to take acrivastine with alcohol or other sedating drugs.[Ref]

Nervous system side effects of pseudoephedrine have included stimulation, resulting in tremor, anxiety, and nervousness. Insomnia has been reported in up to 30% of pseudoephedrine-treated patients. Headache has also been reported.

Nervous system side effects of acrivastine have included uncommon reports of sedation especially when given in combination with pseudoephedrine. Acrivastine has caused more sedation than placebo, but less than other antihistamines with sedating qualities. Acrivastine has also rarely caused headache, somnolence, and dizziness.[Ref]

Cardiovascular

Cardiovascular side effects of pseudoephedrine have included significant increases in heart rate. Hypertension and arrhythmias may be problematic in susceptible patients.[Ref]

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

Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat has occurred in up to 15% of patients.

Gastrointestinal side effects of acrivastine have included dry mouth, and rarely, nausea.[Ref]

Hypersensitivity

Hypersensitivity side effects of pseudoephedrine have included reports of fixed drug eruptions.

Hypersensitivity side effects of acrivastine have included rare reports of reactions.[Ref]

References

1. Cohen AF, Hamilton M, Philipson R, Peck AW "The acute effects of acrivastine (BW825C), a new antihistamine, compared with triprolidine on measures of central nervous system performance and subjective effects." Clin Pharmacol Ther 38 (1985): 381-6

2. Ramaekers JG, Ohanlon JF "Acrivastine, terfenadine and diphenhydramine effects on driving performance as a function of dose and time after dosing." Eur J Clin Pharmacol 47 (1994): 261-6

3. 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

4. Gibbs TG, Irander K, Salo OP "Acrivastine in seasonal allergic rhinitis: two randomized crossover studies to evaluate efficacy and safety." J Int Med Res 16 (1988): 413-9

5. Leynadier F, Murrieta M, Dry J, Colin JN, Gillotin C, Steru D "Effects of acrivastine and terfenadine on skin reactivity to histamine." Ann Allergy 72 (1994): 520-4

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

7. 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

8. Gibbs TG, McDonnell KA, StokesT, Graham AA "Acrivastine in two doses compared with placebo in a multicentre, parallel group study for the treatment of seasonal allergic rhinitis." Br J Clin Pract 43 (1989): 11-4

9. "Product Information. Semprex-D (acrivastine-pseudoephedrine)." Glaxo Wellcome, Research Triangle Park, NC.

10. Cohen AF, Hamilton MJ, Peck AW "The effects of acrivastine (BW825C), diphenhydramine and terfenadine in combination with alcohol on human CNS performance." Eur J Clin Pharmacol 32 (1987): 279-88

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

12. Brogden RN, McTavish D "Acrivastine. A review of its pharmacological properties and therapeutic efficacy in allergic rhinitis, urticaria and related disorders [published erratum appears in Drugs 1991 Oct;42(4):639]." Drugs 41 (1991): 927-40

13. Bojkowski CJ, Gibbs TG, Hellstern KH, Major EW, Mullinger B "Acrivastine in allergic rhinitis: a review of clinical experience." J Int Med Res 17 Suppl 2 (1989): b54-68

14. 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

15. 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

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

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

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

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

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

21. 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

Not all side effects for acrivastine / 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.

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