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Benadryl Children's Allergy And Sinus Side Effects

Generic Name: diphenhydramine / pseudoephedrine

Note: This document contains side effect information about diphenhydramine / pseudoephedrine. Some of the dosage forms listed on this page may not apply to the brand name Benadryl Children's Allergy And Sinus.

For the Consumer

Applies to diphenhydramine / pseudoephedrine: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.
  • Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to diphenhydramine / pseudoephedrine: oral liquid, oral tablet, oral tablet disintegrating

Nervous system

The CNS depressant effect of diphenhydramine parallels its plasma concentrations. The plasma concentration threshold for sedation is 30 to 42 ng/mL, and to cause mental impairment is 58 to 74 ng/mL. Patients should be warned against driving while taking diphenhydramine, and should avoid concomitant ingestion of alcohol.

Dystonic reactions to diphenhydramine have been accompanied by dizziness, mental confusion, rigidity, lip and tongue protrusion, trismus, torticollis, and swallowing difficulties. These reactions generally resolve spontaneously. Toxic encephalopathy has been reported in a child with chicken pox treated generously with topical diphenhydramine.

Delirium has been reported in elderly patients with mild dementia following small oral doses of diphenhydramine.[Ref]

Central nervous system (CNS) depression commonly occurs with diphenhydramine administration, resulting in drowsiness and sedation in nearly all patients treated. Motor skills may be impaired. Dystonic reactions have been reported after single doses of diphenhydramine.

Pseudoephedrine produces nervous system stimulation, resulting in tremor, anxiety, and nervousness. Insomnia is reported in up to 30% of pseudoephedrine-treated patients. Headache may also occur in patients receiving pseudoephedrine.[Ref]

Cardiovascular

Cardiovascular effects of diphenhydramine may include hypotension, tachycardia, and palpitations.

Cardiovascular adverse effects more commonly may be associated with pseudoephedrine. Pseudoephedrine generally causes a significant rise 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 pre-existing hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.[Ref]

Hypersensitivity

Hypersensitivity reactions may occur with diphenhydramine, generally resulting in rash, pruritus and eczema. Photosensitivity reactions have also been reported with diphenhydramine.

Hypersensitivity reactions to pseudoephedrine may also occur. Fixed drug eruptions secondary to pseudoephedrine have been reported.[Ref]

Most commonly, hypersensitivity to diphenhydramine manifests itself in patients receiving systemic drug after being sensitized to it by topical application. Sensitization with systemic administration has also been reported.[Ref]

Gastrointestinal

Gastrointestinal tract adverse effects of diphenhydramine are mild, and may include nausea, dry mouth, and constipation.

Gastrointestinal adverse effects of pseudoephedrine may include anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat may occur in up to 15% of patients.[Ref]

Ocular

Ocular affects of diphenhydramine may include blurred vision, diplopia, and dry eyes due to its anticholinergic effect.[Ref]

Genitourinary

The genitourinary tract may be adversely affected due to the anticholinergic effects of diphenhydramine, resulting in urinary retention and dysuria.[Ref]

Hematologic

Hematologic adverse effects such as hemolytic anemia, thrombocytopenia, and agranulocytosis may be rarely caused by antihistamines.[Ref]

References

1. Borbely AA, Youmbi-Balderer G "Effect of diphenhydramine on subjective sleep parameters and on motor activity during bedtime." Int J Clin Pharmacol Ther Toxicol 26 (1988): 392-6

2. Santora J, Rozek S, Samie MR "Diphenhydramine-induced dystonia ." Clin Pharm 8 (1989): 471

3. 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

4. Brait KA, Zagerman AJ "Dyskinesias after antihistamine use ." N Engl J Med 296 (1977): 111

5. Burns M, Moskowitz H "Effects of diphenhydramine and alcohol on skills performance." Eur J Clin Pharmacol 17 (1980): 259-66

6. Lavenstein BL, Cantor FK "Acute dystonia: an unusual reaction to diphenhydramine." JAMA 236 (1976): 291

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

8. Davenport PM, Wilhelm RE "An unusual vasculitis due to diphenhydramine. Cutaneous and central nervous system involvement." Arch Dermatol 92 (1965): 577-80

9. Roila F, Donati D, Basurto C, Del Favero A "Diphenhydramine and acute dystonia ." Ann Intern Med 111 (1989): 92-3

10. Tejera CA, Saravay SM, Goldman E, Gluck L "Diphenhydramine-induced delirium in elderly hospitalized patients with mild dementia." Psychosomatics 35 (1994): 399-402

11. 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

12. Jones B, Lal S "Tardive dyskinesia uncovered after ingestion of Sominex, an over-the- counter drug." Can J Psychiatry 30 (1985): 370-1

13. Gengo F, Gabos C, Miller JK "The pharmacodynamics of diphenhydramine-induced drowsiness and changes in mental performance." Clin Pharmacol Ther 45 (1989): 15-21

14. Carruthers SG, Shoeman DW, Hignite CE, Azarnoff DL "Correlation between plasma diphenhydramine level and sedative and antihistamine effects." Clin Pharmacol Ther 23 (1978): 375-82

15. Filloux F "Toxic encephalopathy caused by topically applied diphenhydramine." J Pediatr 108 (1986): 1018-20

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

17. 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

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

19. 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

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

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

22. Coskey RJ "Contact dermatitis caused by diphenhydramine hydrochloride." J Am Acad Dermatol 8 (1983): 204-6

23. Emmett EA "Diphenhydramine photoallergy." Arch Dermatol 110 (1974): 249-52

24. 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

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

26. Lawrence CM, Byrne JP "Eczematous eruption from oral diphenhydramine." Contact Dermatitis 7 (1981): 276-7

27. Horio T "Allergic and photoallergic dermatitis from diphenhydramine." Arch Dermatol 112 (1976): 1124-6

28. Seedor JA, Lamberts D, Bergmann RB, Perry HD "Filamentary keratitis associated with diphenhydramine hydrochloride (Benadryl)." Am J Ophthalmol 101 (1986): 376-7

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

Some side effects of Benadryl Children's Allergy And Sinus may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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