PROPYLENE GLYCOL

N/A

Manufactured by Alcon Laboratories, Inc.

8,103 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PROPYLENE GLYCOL

PROPYLENE GLYCOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alcon Laboratories, Inc.. The most commonly reported adverse reactions for PROPYLENE GLYCOL include EYE IRRITATION, EYE PAIN, VISION BLURRED, DRUG INEFFECTIVE, OCULAR HYPERAEMIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PROPYLENE GLYCOL.

Top Adverse Reactions

EYE IRRITATION580 reports
EYE PAIN342 reports
VISION BLURRED316 reports
DRUG INEFFECTIVE284 reports
OCULAR HYPERAEMIA253 reports
DRY EYE211 reports
NAUSEA177 reports
EYE PRURITUS173 reports
PRODUCT QUALITY ISSUE169 reports
FOREIGN BODY SENSATION IN EYES152 reports
OFF LABEL USE136 reports
VOMITING133 reports
DYSPNOEA130 reports
LACRIMATION INCREASED112 reports
ASTHENOPIA106 reports
HEADACHE104 reports
CONDITION AGGRAVATED101 reports
FATIGUE100 reports
EYE DISCHARGE94 reports
CONSTIPATION92 reports
PULMONARY EMBOLISM91 reports
ABDOMINAL PAIN90 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE88 reports
SEPSIS88 reports
DRUG HYPERSENSITIVITY85 reports
SOMNOLENCE84 reports
STRESS82 reports
ABDOMINAL DISTENSION75 reports
ANAEMIA74 reports
DIARRHOEA74 reports
DIZZINESS74 reports
GENERAL PHYSICAL HEALTH DETERIORATION73 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME73 reports
HYPONATRAEMIA71 reports
ASCITES70 reports
VENTRICULAR FIBRILLATION70 reports
APPENDICITIS69 reports
APPENDICOLITH68 reports
DRY MOUTH68 reports
PAIN68 reports
CARDIOGENIC SHOCK66 reports
PYREXIA65 reports
MYASTHENIA GRAVIS64 reports
OEDEMA PERIPHERAL64 reports
THROMBOSIS64 reports
DEATH63 reports
UPPER RESPIRATORY TRACT INFECTION63 reports
SLEEP DISORDER61 reports
HYPERTENSION59 reports
INTENTIONAL PRODUCT MISUSE58 reports
SWELLING58 reports
DRUG INTOLERANCE57 reports
LOWER RESPIRATORY TRACT INFECTION57 reports
DIABETES MELLITUS56 reports
ASTHMA55 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION55 reports
NEURALGIA55 reports
PRODUCT USE IN UNAPPROVED INDICATION54 reports
BLOOD CHOLESTEROL INCREASED53 reports
EYE SWELLING52 reports
FALL52 reports
BLOOD PHOSPHORUS INCREASED50 reports
HYPOPHOSPHATAEMIA50 reports
BACTERIAL INFECTION49 reports
BLOOD URIC ACID INCREASED49 reports
HYPERPHOSPHATAEMIA49 reports
ASTHENIA48 reports
CATARACT48 reports
DYSPHAGIA47 reports
BREATH SOUNDS ABNORMAL46 reports
PNEUMONIA45 reports
PRODUCT DOSE OMISSION ISSUE45 reports
EXPIRED PRODUCT ADMINISTERED44 reports
NASAL CONGESTION44 reports
PRURITUS44 reports
COUGH43 reports
DYSPEPSIA43 reports
VISUAL IMPAIRMENT43 reports
OCULAR DISCOMFORT42 reports
IRON DEFICIENCY40 reports
WHEEZING40 reports
PRESYNCOPE38 reports
TREMOR38 reports
PHOTOPHOBIA37 reports
PRODUCTIVE COUGH37 reports
RASH37 reports
DERMATITIS ATOPIC36 reports
PAIN IN EXTREMITY36 reports
URINARY TRACT INFECTION36 reports
HYPERSENSITIVITY35 reports
ARTHRALGIA34 reports
HYPOTENSION34 reports
MUSCULOSKELETAL STIFFNESS34 reports
CARDIAC MURMUR33 reports
EOSINOPHILIA33 reports
GASTROENTERITIS33 reports
MALAISE33 reports
PNEUMONIA VIRAL33 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE33 reports
WEIGHT DECREASED33 reports

Report Outcomes

Out of 2,679 classified reports for PROPYLENE GLYCOL:

Serious 37.0%Non-Serious 63.0%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female1,779 (71.1%)
Male721 (28.8%)
Unknown3 (0.1%)

Reports by Age

Age 80110 reports
Age 7250 reports
Age 6948 reports
Age 6639 reports
Age 7037 reports
Age 8935 reports
Age 5230 reports
Age 7128 reports
Age 7428 reports
Age 7628 reports
Age 6427 reports
Age 6827 reports
Age 7527 reports
Age 6526 reports
Age 8226 reports
Age 7725 reports
Age 5824 reports
Age 6223 reports
Age 6323 reports
Age 7323 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with PROPYLENE GLYCOL?

This profile reflects 8,103 FDA FAERS reports that mention PROPYLENE GLYCOL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PROPYLENE GLYCOL?

Frequently reported terms in FAERS include EYE IRRITATION, EYE PAIN, VISION BLURRED, DRUG INEFFECTIVE, OCULAR HYPERAEMIA, DRY EYE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PROPYLENE GLYCOL?

Labeling and FAERS entries often list Alcon Laboratories, Inc. in connection with PROPYLENE GLYCOL. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.