PHENIRAMINE: 67 Adverse Event Reports & Safety Profile
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Route: ORAL · Manufacturer: Poly Pharmaceuticals, Inc. · HUMAN OTC DRUG · FDA Label: Available
First Report: 2013 · Latest Report: 20240415
What Are the Most Common PHENIRAMINE Side Effects?
All PHENIRAMINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug abuse | 8 | 11.9% | 6 | 4 |
| Sepsis | 8 | 11.9% | 6 | 5 |
| Drug dependence | 7 | 10.5% | 4 | 6 |
| Urticaria | 7 | 10.5% | 1 | 4 |
| Dyspnoea | 6 | 9.0% | 3 | 2 |
| Seizure | 6 | 9.0% | 0 | 0 |
| Cardiac arrest | 5 | 7.5% | 4 | 2 |
| Drug ineffective | 5 | 7.5% | 2 | 3 |
| Hyperkalaemia | 5 | 7.5% | 5 | 4 |
| Toxicity to various agents | 5 | 7.5% | 1 | 3 |
| Ventricular fibrillation | 5 | 7.5% | 5 | 3 |
Who Reports PHENIRAMINE Side Effects? Age & Gender Data
Gender: 57.1% female, 42.9% male. Average age: 37.9 years. Most reports from: TR. View detailed demographics →
Is PHENIRAMINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 5 | 3 | 2 |
| 2014 | 2 | 2 | 1 |
| 2015 | 2 | 0 | 2 |
| 2016 | 3 | 2 | 1 |
| 2017 | 1 | 0 | 0 |
| 2019 | 1 | 0 | 0 |
| 2023 | 1 | 0 | 0 |
| 2024 | 2 | 0 | 1 |
What Is PHENIRAMINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 24 |
| Anaphylactic reaction | 5 |
Official FDA Label for PHENIRAMINE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
USES Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages
Dosage & Administration
DIRECTIONS Directions Adults and children 12 years of age and over 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours Children 6 to under 12 years of age Children under 6 consult a doctor 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours
Warnings
WARNINGS Do not exceed recommended dosage. Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to enlargement of the prostate gland heart disease high blood pressure thyroid disease diabetes Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding, ask a health professional before use.
Active Ingredient
ACTIVE INGREDIENT Active Ingredient (in each tablet)
Purpose Pheniramine Maleate
17mg Antihistamine Phenylephrine HCl 10mg Nasal Decongestant
Inactive Ingredients
INACTIVE INGREDIENTS Inactive ingredients Magnesium Stearate, Microcrystalline Cellulose, Natural Yellow, Sodium Starch Glycolate