PHENYLEPHRINE HYDROCHLORIDE

N/A

Manufactured by Belmora LLC

65,609 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PHENYLEPHRINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Belmora LLC. The most commonly reported adverse reactions for PHENYLEPHRINE HYDROCHLORIDE include OFF LABEL USE, PEMPHIGUS, JOINT SWELLING, DRUG INEFFECTIVE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PHENYLEPHRINE HYDROCHLORIDE.

Top Adverse Reactions

OFF LABEL USE1,210 reports
PEMPHIGUS948 reports
JOINT SWELLING920 reports
DRUG INEFFECTIVE903 reports
PAIN902 reports
RHEUMATOID ARTHRITIS872 reports
PERICARDITIS868 reports
SYSTEMIC LUPUS ERYTHEMATOSUS867 reports
INFUSION RELATED REACTION846 reports
WOUND843 reports
GLOSSODYNIA837 reports
SYNOVITIS833 reports
ARTHROPATHY823 reports
CONDITION AGGRAVATED822 reports
MATERNAL EXPOSURE DURING PREGNANCY806 reports
TYPE 2 DIABETES MELLITUS804 reports
HEPATIC ENZYME INCREASED791 reports
MOBILITY DECREASED790 reports
RASH786 reports
HAND DEFORMITY776 reports
HELICOBACTER INFECTION776 reports
PNEUMONIA775 reports
FOLLICULITIS773 reports
SWELLING769 reports
PSORIATIC ARTHROPATHY751 reports
ABDOMINAL DISCOMFORT750 reports
ARTHRALGIA750 reports
PAIN IN EXTREMITY748 reports
DRUG INTOLERANCE746 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE732 reports
DUODENAL ULCER PERFORATION730 reports
ALOPECIA729 reports
HYPOAESTHESIA729 reports
WEIGHT INCREASED728 reports
GENERAL PHYSICAL HEALTH DETERIORATION716 reports
NAUSEA700 reports
FATIGUE698 reports
HYPERTENSION689 reports
INJURY689 reports
IRRITABLE BOWEL SYNDROME672 reports
CONFUSIONAL STATE668 reports
CONTRAINDICATED PRODUCT ADMINISTERED665 reports
INTENTIONAL PRODUCT USE ISSUE662 reports
PERIPHERAL SWELLING660 reports
URTICARIA660 reports
PRODUCT USE IN UNAPPROVED INDICATION657 reports
MUSCULOSKELETAL STIFFNESS651 reports
TREATMENT FAILURE647 reports
BLISTER646 reports
BLOOD CHOLESTEROL INCREASED646 reports
HEADACHE646 reports
NASOPHARYNGITIS642 reports
WHEEZING639 reports
VOMITING637 reports
IMPAIRED HEALING631 reports
STOMATITIS628 reports
MUSCLE INJURY619 reports
DRUG HYPERSENSITIVITY618 reports
LOWER RESPIRATORY TRACT INFECTION617 reports
BURSITIS613 reports
SLEEP DISORDER611 reports
GASTROOESOPHAGEAL REFLUX DISEASE606 reports
LIVER INJURY606 reports
WOUND INFECTION606 reports
ABDOMINAL PAIN UPPER596 reports
HYPERSENSITIVITY596 reports
DYSPNOEA579 reports
FIBROMYALGIA579 reports
THERAPEUTIC PRODUCT EFFECT DECREASED564 reports
DYSPEPSIA562 reports
DIARRHOEA560 reports
GAIT INABILITY559 reports
HYPERCHOLESTEROLAEMIA546 reports
MALAISE545 reports
GASTROINTESTINAL DISORDER542 reports
PRODUCT USE ISSUE536 reports
RHEUMATIC FEVER536 reports
MIGRAINE532 reports
INFLAMMATION518 reports
DEPRESSION514 reports
JOINT RANGE OF MOTION DECREASED514 reports
C REACTIVE PROTEIN INCREASED511 reports
ASTHENIA498 reports
INSOMNIA498 reports
DIZZINESS495 reports
MUSCULAR WEAKNESS495 reports
MUSCULOSKELETAL PAIN492 reports
MEMORY IMPAIRMENT491 reports
DRY MOUTH480 reports
OSTEOARTHRITIS479 reports
NAIL DISORDER477 reports
BREAST CANCER STAGE III476 reports
PARAESTHESIA476 reports
PERIPHERAL VENOUS DISEASE475 reports
LUNG DISORDER464 reports
GRIP STRENGTH DECREASED459 reports
NECK PAIN454 reports
MUSCLE SPASMS447 reports
TASTE DISORDER446 reports
BLEPHAROSPASM440 reports

Report Outcomes

Out of 3,671 classified reports for PHENYLEPHRINE HYDROCHLORIDE:

Serious 92.3%Non-Serious 7.7%

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

Female2,482 (83.0%)
Male495 (16.6%)
Unknown12 (0.4%)

Reports by Age

Age 40568 reports
Age 43469 reports
Age 7784 reports
Age 4474 reports
Age 5971 reports
Age 6267 reports
Age 9749 reports
Age 5244 reports
Age 3637 reports
Age 6630 reports
Age 9628 reports
Age 4223 reports
Age 7123 reports
Age 7222 reports
Age 3221 reports
Age 3521 reports
Age 6721 reports
Age 6821 reports
Age 5820 reports
Age 7020 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 PHENYLEPHRINE HYDROCHLORIDE?

This profile reflects 65,609 FDA FAERS reports that mention PHENYLEPHRINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PHENYLEPHRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include OFF LABEL USE, PEMPHIGUS, JOINT SWELLING, DRUG INEFFECTIVE, PAIN, RHEUMATOID ARTHRITIS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PHENYLEPHRINE HYDROCHLORIDE?

Labeling and FAERS entries often list Belmora LLC in connection with PHENYLEPHRINE HYDROCHLORIDE. 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.