PYRILAMINE: 64 Adverse Event Reports & Safety Profile
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Active Ingredient: PYRILAMINE MALEATE · Route: ORAL · Manufacturer: GM Pharmaceuticals, INC · FDA Application: 080808 · HUMAN OTC DRUG · FDA Label: Available
First Report: 20140603 · Latest Report: 20240625
What Are the Most Common PYRILAMINE Side Effects?
All PYRILAMINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 47 | 73.4% | 0 | 46 |
| Drug hypersensitivity | 46 | 71.9% | 0 | 44 |
| General physical health deterioration | 46 | 71.9% | 0 | 46 |
| Product dose omission issue | 46 | 71.9% | 0 | 46 |
| Constipation | 45 | 70.3% | 0 | 44 |
| Anaemia | 44 | 68.8% | 0 | 44 |
| Aspiration | 44 | 68.8% | 0 | 44 |
| Asthma | 44 | 68.8% | 0 | 44 |
| Blood calcium increased | 44 | 68.8% | 0 | 44 |
| Blood creatinine increased | 44 | 68.8% | 0 | 44 |
| Bronchopulmonary aspergillosis allergic | 44 | 68.8% | 0 | 44 |
| Headache | 44 | 68.8% | 0 | 44 |
| Musculoskeletal stiffness | 44 | 68.8% | 0 | 44 |
| Oedema peripheral | 44 | 68.8% | 0 | 44 |
| Pneumonia | 44 | 68.8% | 0 | 44 |
| Pulmonary fibrosis | 44 | 68.8% | 0 | 44 |
| Pulmonary mass | 44 | 68.8% | 0 | 44 |
| Transaminases increased | 44 | 68.8% | 0 | 44 |
| Upper respiratory tract infection | 44 | 68.8% | 0 | 44 |
| Abdominal pain upper | 43 | 67.2% | 0 | 43 |
Who Reports PYRILAMINE Side Effects? Age & Gender Data
Gender: 95.5% female, 4.5% male. Average age: 75.8 years. Most reports from: CA. View detailed demographics →
Is PYRILAMINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 1 |
| 2015 | 2 | 0 | 0 |
| 2016 | 1 | 0 | 0 |
| 2017 | 2 | 0 | 0 |
| 2022 | 1 | 1 | 0 |
| 2024 | 1 | 0 | 1 |
What Is PYRILAMINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 46 |
Official FDA Label for PYRILAMINE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses ■ temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.
Dosage & Administration
Directions ■ mL= milliliter ■ use enclosed 15 mL dose cup and keep with product ■ children 6 to under 12 years: 30 mL (2 dose cups) every 6 to 8 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor ■ children under 6 years of age: consult a doctor.
Warnings
Warnings Ask a doctor before use if the child has ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma Ask a doctor before use if the child is taking sedatives or tranquilizers When using this product ■ marked drowsiness may occur ■ sedatives and tranquilizers may increase drowsiness ■ excitability may occur, especially in children Stop use and ask a doctor if new symptoms occur Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Active Ingredient
Active ingredients (in each 15 mL)
Pyrilamine Maleate
12.5 mg
Inactive Ingredients
Inactive ingredients citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose