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Naphazoline Side Effects

The most commonly reported side effects of naphazoline include eye irritation, mydriasis, and product use in unapproved indication, based on 4,713 FDA adverse event reports from 2004 to 2025. 11.5% of reports found the drug to be ineffective.

Naphazoline side effects

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

1
Eye Irritation15.5%730
2
Drug Ineffective11.5%543
3
Mydriasis7.6%356
4
Product Use In Unapproved Indication6.2%290
5
Eye Pain6.1%288
6
Vision Blurred5.4%256
7
Mydriasis5.0%238
8
Ocular Hyperaemia5.0%235
9
Eye Irritation5.0%234
10
Off Label Use4.7%223
11
Headache3.5%166
12
Fatigue3.3%154
13
Pain3.0%143
14
Therapeutic Response Unexpected2.9%139
15
Vision Blurred2.9%135

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

Report severity

24.5%Serious1,157 reports
7.6%Hospitalizations359 reports
1.6%Fatal77 reports

Seriousness is determined by the reporter, not by OpenClaim.

Naphazoline drug interactions

Other drugs that appear in adverse event reports alongside naphazoline. 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
Pheniramine-maleate70.8%3,335
2
Bimatoprost2.1%100
3
Adalimumab1.9%91
4
Aspirin1.7%81
5
Prednisone1.7%80
6
Infliximab1.7%78
7
Omeprazole1.7%78
8
Furosemide1.6%77
9
Budesonide1.6%76
10
Levothyroxine-sodium1.6%76
11
Warfarin1.6%74
12
Rosuvastatin1.5%73
13
Mesalamine1.5%73
14
Vedolizumab1.5%72
15
Escitalopram-oxalate1.5%71

Taken alongside

1
Pheniramine-maleate14.5%682
2
Acetaminophen7.6%357
3
Ergocalciferol5.7%267
4
Aspirin5.4%254
5
Levothyroxine-sodium4.5%214
6
Omeprazole4.5%214
7
Atorvastatin-calcium4.4%206
8
Fluticasone4.2%198
9
Albuterol4.1%194
10
Amlodipine4.0%190
11
Cetirizine-hydrochloride2.9%137
12
Folic-acid2.9%136
13
Lisinopril2.6%122
14
Calcium2.6%121
15
Metoprolol2.6%121

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 naphazoline side effects

54.3% of naphazoline adverse event reports involve female patients and 28.6% involve male patients. The largest age group is adult at 58%. These figures reflect who reports side effects, not underlying risk.

Sex

Female54.3%
Male28.6%
Unknown17.2%

Age group

< 20.6%
2–111.8%
12–172.1%
18–6458.4%
65+37.1%

What is naphazoline used for

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

Abnormal Sensation In EyeAccidental ExposureAccidental Exposure To ProductAcneAdverse Drug ReactionAdverse ReactionAllergy ProphylaxisAllergy To AnimalAnaesthesiaAnalgesic TherapyAntiallergic TherapyArthropod BiteAsthenopiaAstigmatismAtopic Keratoconjunctivitis

Showing 15 of 201 indications

Naphazoline brand names and reporting trend

Naphazoline is sold under the brand name Albalon.

Brand names

Albalon2

Quarterly reports (20042025)

20052010201520202025

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

Taking naphazoline with another medication?

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