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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

HYPROMELLOSES: 91 Adverse Event Reports & Safety Profile

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91
Total FAERS Reports
2 (2.2%)
Deaths Reported
11
Hospitalizations
91
As Primary/Secondary Suspect
2
Life-Threatening
4
Disabilities
YD BIO USA, INC.
Manufacturer

Route: OPHTHALMIC · Manufacturer: YD BIO USA, INC. · HUMAN OTC DRUG · FDA Label: Available

First Report: 20100726 · Latest Report: 20220606

What Are the Most Common HYPROMELLOSES Side Effects?

#1 Most Reported
Pancytopenia
23 reports (25.3%)
#2 Most Reported
Headache
16 reports (17.6%)
#3 Most Reported
Dry eye
10 reports (11.0%)

All HYPROMELLOSES Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pancytopenia 23 25.3% 0 0
Headache 16 17.6% 0 2
Dry eye 10 11.0% 0 0
Cholangiocarcinoma 9 9.9% 0 0
Eye irritation 9 9.9% 0 0
Visual impairment 9 9.9% 0 0
Nasopharyngitis 8 8.8% 0 2
Pulmonary congestion 8 8.8% 1 1
Aphasia 7 7.7% 0 0
Hepatic cirrhosis 7 7.7% 0 0
Lacrimation increased 7 7.7% 0 0
Arthropathy 6 6.6% 0 0
Contraindicated product administered 6 6.6% 0 0
Eye inflammation 6 6.6% 0 0
Fatigue 6 6.6% 1 2
Pruritus 6 6.6% 0 0
Rhinitis 6 6.6% 0 0
Sensation of foreign body 6 6.6% 0 0
Skin disorder 6 6.6% 0 0
Dizziness 5 5.5% 1 1

Who Reports HYPROMELLOSES Side Effects? Age & Gender Data

Gender: 61.4% female, 38.6% male. Average age: 68.8 years. Most reports from: GB. View detailed demographics →

Is HYPROMELLOSES Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 1 0 0
2013 1 0 1
2014 1 0 0
2015 1 0 1
2016 8 0 0
2017 1 0 0
2018 7 1 1
2019 8 0 0
2020 12 0 4
2021 1 0 0
2022 2 0 0

View full timeline →

What Is HYPROMELLOSES Used For?

IndicationReports
Product used for unknown indication 45
Dry eye 12

Official FDA Label for HYPROMELLOSES

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses For use as a protectant against further irritation or to relieve dryness of the eye. For the temporary relief of burning & irritation due to the dryness of the eye. Relieves redness of the eye due to minor eye irritations.

Dosage & Administration

Directions Shake well before using Instill 1-2 drops in the affected eye(s) as needed

Warnings

Warnings For external use only. Do not use if solution changes color or becomes cloudy. Ask a doctor before use if you have narrow angle glaucoma When using this product: To avoid contamination, do not touch tip of container to any surface. Replace cap after using. Overuse of this product may produce increased redness of the eye. Pupils may become enlarged temporarily. Stop use & as k a doctor if: you experience eye pain you experience changes in vision you experience continued redness or irritation of the eye the condition worsens symptoms last for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Active Ingredients Hypromellose 0.20%

Active Ingredients Naphazoline Hydrochloride 0.025%

Active Ingredients Polysorbate 80 0.50%

Active Ingredients Zinc Sulfate 0.25%

Inactive Ingredients

Inactive Ingredients calcium chloride, citric acid, edetate disodium, magnesium chloride, potassium chloride, purified water, sodium citrate, sodium chloride and sorbic acid.