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Loteprednol Side Effects

The most commonly reported side effects of loteprednol include eye pain, eye irritation, and off label use, based on 6,085 FDA adverse event reports from 2004 to 2025. 7.1% of reports found the drug to be ineffective.

Loteprednol side effects

Percentages show how often each reaction appears relative to total reports for loteprednol.

1
Eye Pain12.0%732
2
Eye Irritation9.8%599
3
Off Label Use8.6%523
4
Drug Ineffective7.1%432
5
Vision Blurred6.8%413
6
Ocular Hyperaemia6.0%368
7
Headache4.8%290
8
Fatigue4.2%253
9
Dry Eye3.6%221
10
Product Dose Omission Issue3.3%203
11
Lacrimation Increased3.1%191
12
Pain3.1%189
13
Product Use In Unapproved Indication3.1%189
14
Visual Impairment3.1%187
15
Nausea3.0%185

These are voluntary reports and do not establish that loteprednol caused these reactions.

Report severity

33.7%Serious2,049 reports
11.5%Hospitalizations700 reports
2.5%Fatal153 reports

Seriousness is determined by the reporter, not by OpenClaim.

Loteprednol drug interactions

Other drugs that appear in adverse event reports alongside loteprednol. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Cenegermin-bkbj11.8%716
2
Cyclosporine4.8%290
3
Tobramycin4.5%273
4
Dupilumab3.2%196
5
Sodium-oxybate3.1%187
6
Lenalidomide2.8%170
7
Adalimumab2.3%141
8
Bromfenac-sodium1.7%103
9
Besifloxacin-hydrochloride1.6%98
10
Esomeprazole1.6%95
11
Prednisolone1.2%76
12
Omeprazole1.2%75
13
Lifitegrast1.2%71
14
Brimonidine-tartrate1.2%70
15
Timolol1.1%69

Taken alongside

1
Ergocalciferol16.2%988
2
Acetaminophen13.7%832
3
Levothyroxine-sodium12.8%779
4
Aspirin12.7%771
5
Cyclosporine12.5%759
6
Fluticasone9.8%598
7
Atorvastatin-calcium9.4%570
8
Albuterol9.0%546
9
Prednisone9.0%545
10
Gabapentin8.4%513
11
Omeprazole8.3%507
12
Metoprolol8.2%496
13
Amlodipine8.0%484
14
Timolol7.1%433
15
Acyclovir7.1%430

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports loteprednol side effects

71.3% of loteprednol adverse event reports involve female patients and 23.8% involve male patients. The largest age group is elderly at 54%. These figures reflect who reports side effects, not underlying risk.

Sex

Female71.3%
Male23.8%
Unknown4.9%

Age group

< 20.1%
2–110.5%
12–170.7%
18–6444.7%
65+54.0%

What is loteprednol used for

Conditions and purposes for which patients were taking loteprednol when the adverse event was reported.

Abnormal Sensation In EyeAdenoviral ConjunctivitisAdverse Drug ReactionAllergy To AnimalAllergy To PlantsAntibiotic TherapyAntiinflammatory TherapyAnxietyArthritisArthropod BiteAsthenopiaAsthmaAtopic KeratoconjunctivitisAutoimmune DisorderAdverse Drug Reaction

Showing 15 of 346 indications

Loteprednol brand names and reporting trend

Loteprednol is sold under the brand name Alrex.

Brand names

Alrex750

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking loteprednol with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.