PROPYLHEXEDRINE: 50 Adverse Event Reports & Safety Profile
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Route: NASAL · Manufacturer: BF ASCHER AND CO INC · HUMAN OTC DRUG · FDA Label: Available
First Report: 19851001 · Latest Report: 20250723
What Are the Most Common PROPYLHEXEDRINE Side Effects?
All PROPYLHEXEDRINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug abuse | 11 | 22.0% | 0 | 4 |
| Drug dependence | 11 | 22.0% | 1 | 6 |
| Acute kidney injury | 9 | 18.0% | 9 | 5 |
| Hypotension | 9 | 18.0% | 9 | 5 |
| Metabolic acidosis | 9 | 18.0% | 9 | 5 |
| Pneumonia aspiration | 9 | 18.0% | 9 | 5 |
| Respiratory depression | 9 | 18.0% | 9 | 5 |
| Tachycardia | 9 | 18.0% | 9 | 5 |
| Toxicity to various agents | 9 | 18.0% | 9 | 6 |
| Depressed level of consciousness | 8 | 16.0% | 8 | 4 |
| Tremor | 8 | 16.0% | 7 | 5 |
| Coma | 7 | 14.0% | 7 | 5 |
| Hyperreflexia | 7 | 14.0% | 7 | 4 |
| Euphoric mood | 6 | 12.0% | 0 | 2 |
| Anion gap | 5 | 10.0% | 5 | 2 |
Who Reports PROPYLHEXEDRINE Side Effects? Age & Gender Data
Gender: 13.0% female, 87.0% male. Average age: 28.0 years. Most reports from: US. View detailed demographics →
Is PROPYLHEXEDRINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 0 |
| 2015 | 2 | 1 | 2 |
| 2016 | 2 | 0 | 1 |
| 2017 | 2 | 0 | 0 |
| 2018 | 2 | 0 | 0 |
| 2019 | 1 | 0 | 0 |
| 2020 | 3 | 0 | 1 |
| 2021 | 9 | 2 | 6 |
| 2023 | 3 | 0 | 3 |
| 2025 | 2 | 0 | 0 |
What Is PROPYLHEXEDRINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 18 |
Official FDA Label for PROPYLHEXEDRINE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses For the temporarily relief of nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis).
Dosage & Administration
Directions adults and children 6 to 12 years of age (with adult supervision): two inhalations in each nostril not more than every two hours. children under 6 years of age: consult a doctor
Warnings
Warnings Do not exceed recommended dosage. This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. Ill effects may result if taken internally
Active Ingredient
Active ingredient.................
Purpose Propylhexedrine
175 mg......Nasal decongestant
Inactive Ingredients
Inactive ingredients lavender oil, menthol