Tavist-1 Side Effects

Generic Name: clemastine

Note: This page contains side effects data for the generic drug clemastine. It is possible that some of the dosage forms included below may not apply to the brand name Tavist-1.

It is possible that some side effects of Tavist-1 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 clemastine: oral oral solution, oral tablets

Side effects include:

Sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, thickening of bronchial secretions.

For Healthcare Professionals

Applies to clemastine: compounding powder, oral syrup, oral tablet

Nervous system

Nervous system side effects have included central nervous system depression which has commonly resulted in drowsiness, dizziness, and headache. Dyskinesias have rarely been reported following chronic use of antihistamines.[Ref]

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

Few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of antihistamines 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.[Ref]

Gastrointestinal

Gastrointestinal side effects have included dry mouth and constipation due to anticholinergic effects. This has occurred in up to one-third of patients.[Ref]

Cardiovascular

Cardiovascular side effects have included hypotension, tachycardia, and palpitations.[Ref]

Ocular

Ocular effects are due to the anticholinergic effects and may include blurred vision, diplopia, and dry eyes.[Ref]

Genitourinary

Genitourinary side effects have included dysuria, urinary hesitancy, decrease in urine flow, and in rare cases, acute urinary retention.[Ref]

Hematologic

Hematologic side effects that have been reported with antihistamines include 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]

Respiratory

Respiratory side effects have included thickening of bronchial secretions, wheezing, and tightness in the chest.[Ref]

Dermatologic

At least one case of toxic pustuloderma has been reported during clemastine (the active ingredient contained in Tavist-1) therapy.[Ref]

Dermatologic side effects have included toxic pustuloderma.[Ref]

References

1. Schran HF, Petryk L, Chang CT, Oconnor R, Gelbert MB "The pharmacokinetics and bioavailability of clemastine and phenylpropanolamine in single-component and combination formulations." J Clin Pharmacol 36 (1996): 911-22

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

3. Frolund L, Etholm B, Irander K, Johannessen TA, Odkvist L, Ohlander B, Weeke B "A multicentre study of loratadine, clemastine and placebo in patients with perennial allergic rhinitis." Allergy 45 (1990): 254-61

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

5. "Product Information. Tavist (clemastine)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

6. 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

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

8. Turner RB, Sperber SJ, Sorrentino JV, OConnor RR, Rogers J, Batouli AR, Gwaltney JM "Effectiveness of clemastine fumarate for treatment of rhinorrhea and sneezing associated with the common cold." Clin Infect Dis 25 (1997): 824-30

9. Gwaltney JM, Park J, Paul RA, Edelman DA, Oconnor RR, Turner RB "Randomized controlled trial of clemastine fumarate for treatment of experimental rhinovirus colds." Clin Infect Dis 22 (1996): 656-62

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

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

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

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

14. Feindkoopmans A, Vandervalk PGM, Steijlen PM, Vandekerkhof PCM "Toxic pustuloderma associated with clemastine therapy." Clin Exp Dermatol 21 (1996): 293-5

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