TRIPROLIDINE: 170 Adverse Event Reports & Safety Profile
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Active Ingredient: TRIPROLIDINE HYDROCHLORIDE · Route: ORAL · Manufacturer: GM Pharmaceuticals, INC · FDA Application: 011110 · HUMAN OTC DRUG · FDA Label: Available
First Report: 20100901 · Latest Report: 20231031
What Are the Most Common TRIPROLIDINE Side Effects?
All TRIPROLIDINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Psoriatic arthropathy | 110 | 64.7% | 30 | 31 |
| Type 2 diabetes mellitus | 109 | 64.1% | 30 | 31 |
| Pericarditis | 108 | 63.5% | 28 | 29 |
| Joint swelling | 106 | 62.4% | 27 | 30 |
| Oedema | 106 | 62.4% | 28 | 31 |
| Pemphigus | 105 | 61.8% | 26 | 27 |
| Pyrexia | 105 | 61.8% | 25 | 26 |
| Sinusitis | 104 | 61.2% | 25 | 26 |
| Urticaria | 103 | 60.6% | 23 | 24 |
| Injury | 102 | 60.0% | 26 | 27 |
| Mobility decreased | 102 | 60.0% | 26 | 27 |
| Weight increased | 102 | 60.0% | 23 | 24 |
| Nausea | 100 | 58.8% | 19 | 22 |
| Pneumonia | 98 | 57.7% | 18 | 19 |
| Sleep disorder | 95 | 55.9% | 18 | 19 |
| Stomatitis | 95 | 55.9% | 16 | 17 |
| Gait disturbance | 94 | 55.3% | 16 | 19 |
| Liver injury | 94 | 55.3% | 17 | 18 |
| Insomnia | 92 | 54.1% | 17 | 18 |
| Pain in extremity | 92 | 54.1% | 15 | 16 |
Who Reports TRIPROLIDINE Side Effects? Age & Gender Data
Gender: 98.5% female, 1.5% male. Average age: 71.0 years. Most reports from: CA. View detailed demographics →
Is TRIPROLIDINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 2 | 0 | 2 |
| 2014 | 1 | 0 | 0 |
| 2015 | 2 | 1 | 2 |
| 2016 | 1 | 0 | 0 |
| 2023 | 1 | 0 | 0 |
What Is TRIPROLIDINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 132 |
| Hypersensitivity | 8 |
TRIPROLIDINE vs Alternatives: Which Is Safer?
Official FDA Label for TRIPROLIDINE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: 1. runny nose 2. sneezing 3. itching of the nose or throat 4. itchy, watery eyes
Dosage & Administration
Directions do not exceed recommended dosage. use only the enclosed dropper do not use enclosed dropper for any other drug product.
Age Dose
Adults & Children 12 years of age or older: 2.67 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 mL (10 milligrams) in 24 hours, or as directed by a doctor.
Children
6 to under 12 years of age: 1.33 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 mL (5 milligrams) 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 you have
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis Ask a doctor before use if you are taking sedatives or tranquilizers. When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic beverages while taking this product
- be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if new symptoms occur. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredient
Active ingredient (in each 1 mL dropperful) Triprolidine HCl 0.938 mg
Inactive Ingredients
Inactive ingredients bubble gum flavor, citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.