TETRAHYDROZOLINE: 722 Adverse Event Reports & Safety Profile
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Active Ingredient: TETRAHYDROZOLINE HYDROCHLORIDE · Route: OPHTHALMIC · Manufacturer: Strategic Sourcing Services LLC · FDA Application: 086576 · HUMAN OTC DRUG · FDA Label: Available
First Report: 20010324 · Latest Report: 20240327
What Are the Most Common TETRAHYDROZOLINE Side Effects?
All TETRAHYDROZOLINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 201 | 27.8% | 0 | 3 |
| Eye irritation | 83 | 11.5% | 0 | 1 |
| Ocular hyperaemia | 59 | 8.2% | 0 | 2 |
| Product use issue | 59 | 8.2% | 0 | 3 |
| Therapeutic response unexpected | 39 | 5.4% | 0 | 0 |
| Accidental exposure to product | 38 | 5.3% | 2 | 6 |
| Intentional product misuse | 38 | 5.3% | 5 | 1 |
| Product use in unapproved indication | 38 | 5.3% | 0 | 3 |
| Off label use | 36 | 5.0% | 0 | 3 |
| Drug effect incomplete | 25 | 3.5% | 0 | 0 |
| Drug ineffective for unapproved indication | 25 | 3.5% | 0 | 0 |
| Poisoning deliberate | 24 | 3.3% | 9 | 2 |
| Vision blurred | 23 | 3.2% | 0 | 0 |
| Diarrhoea | 21 | 2.9% | 1 | 6 |
| Eye pain | 19 | 2.6% | 0 | 0 |
| Wrong technique in product usage process | 18 | 2.5% | 1 | 0 |
| Toxicity to various agents | 16 | 2.2% | 8 | 9 |
| Expired product administered | 14 | 1.9% | 0 | 0 |
| Malaise | 13 | 1.8% | 0 | 5 |
| Dry eye | 12 | 1.7% | 0 | 0 |
Who Reports TETRAHYDROZOLINE Side Effects? Age & Gender Data
Gender: 47.5% female, 52.5% male. Average age: 52.4 years. Most reports from: US. View detailed demographics →
Is TETRAHYDROZOLINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 2 | 0 | 2 |
| 2010 | 1 | 0 | 1 |
| 2011 | 1 | 0 | 0 |
| 2014 | 4 | 0 | 1 |
| 2015 | 11 | 1 | 1 |
| 2016 | 6 | 0 | 1 |
| 2017 | 9 | 0 | 0 |
| 2018 | 9 | 2 | 1 |
| 2019 | 4 | 0 | 0 |
| 2020 | 6 | 0 | 1 |
| 2021 | 3 | 2 | 1 |
| 2022 | 1 | 0 | 0 |
| 2023 | 5 | 0 | 0 |
| 2024 | 3 | 0 | 1 |
What Is TETRAHYDROZOLINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 394 |
| Ocular hyperaemia | 124 |
| Accidental exposure to product | 37 |
| Dry eye | 35 |
| Eye irritation | 32 |
| Eye pruritus | 19 |
| Eye disorder | 12 |
| Erythema | 11 |
| Hypersensitivity | 7 |
| Multiple allergies | 7 |
TETRAHYDROZOLINE vs Alternatives: Which Is Safer?
Official FDA Label for TETRAHYDROZOLINE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Directions to open bottle, push cap down and twist counterclockwise put 1 to 2 drops in the affected eye(s) up to 4 times daily children under 6 years of age: ask a doctor
Dosage & Administration
Directions adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day children under 6 years of age: consult a doctor children under 2 years of age: do not use
Warnings
Warnings Warnings For external use only Ask a doctor before use if you have Ask a doctor before use if you have narrow angle glaucoma When using this product When using this product pupils may become enlarged temporarily to avoid contamination, do not touch tip of container to any surface. Replace cap after using. if solution changes color or becomes cloudy, do not use overuse may produce increased redness of the eye remove contact lens before using Stop use and ask a doctor if Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Active Ingredient
Active ingredient Purpose Tetrahydrozoline HCI 0.05%...........................................Eye redness reliever
Inactive Ingredients
Inactive ingredients ascorbic acid, boric acid, dextrose, glycerin, glycine, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium borate, sodium citrate, sodium lactate, sodium phosphate dibasic