Benaphen Plus Side Effects

Generic Name: diphenhydramine / pseudoephedrine

Note: This page contains information about the side effects of diphenhydramine / pseudoephedrine. Some of the dosage forms included on this document may not apply to the brand name Benaphen Plus.

Not all side effects for Benaphen Plus may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to diphenhydramine / pseudoephedrine: liquid, sustained-release tablets, tablets

Other dosage forms:

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, and throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur while taking diphenhydramine / pseudoephedrine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mood or mental changes; persistent trouble sleeping; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; trouble urinating or inability to urinate; unusual bruising or bleeding.

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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