Tavist NightTime Allergy 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 Tavist NightTime Allergy.

Some side effects of Tavist NightTime Allergy may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to diphenhydramine / pseudoephedrine: oral liquid, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking diphenhydramine / pseudoephedrine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• pounding heartbeats or fluttering in your chest;

• confusion, hallucinations, unusual thoughts or behavior;

• severe dizziness, anxiety, or nervousness;

• dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, chest pain, trouble breathing, uneven heart rate, seizure);

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

• urinating less than usual or not at all.

Less serious side effects of diphenhydramine / pseudoephedrine may include:

• blurred vision;

• dry mouth;

• nausea, stomach pain, constipation;

• mild loss of appetite, stomach upset;

• warmth, redness, or tingly feeling under your skin;

• sleep problems (insomnia);

• feeling restless or excited (especially in children);

• skin rash or itching;

• dizziness, drowsiness;

• problems with memory or concentration; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

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.

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.

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.

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.

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.

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.

Ocular

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

Genitourinary

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

Hematologic

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

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