PHENYLEPHRINE HCL

N/A

Manufactured by Strategic Sourcing Services LLC

4,600 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PHENYLEPHRINE HCL

PHENYLEPHRINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Strategic Sourcing Services LLC. The most commonly reported adverse reactions for PHENYLEPHRINE HCL include PAIN, INJURY, RENAL FAILURE, ANXIETY, UNEVALUABLE EVENT. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PHENYLEPHRINE HCL.

Top Adverse Reactions

PAIN250 reports
INJURY227 reports
RENAL FAILURE220 reports
ANXIETY194 reports
UNEVALUABLE EVENT191 reports
FEAR175 reports
EMOTIONAL DISTRESS153 reports
RENAL INJURY153 reports
STRESS129 reports
RENAL IMPAIRMENT126 reports
ANHEDONIA123 reports
MULTI ORGAN FAILURE113 reports
DEATH110 reports
DEPRESSION96 reports
DRUG INEFFECTIVE63 reports
ARTHRALGIA48 reports
CONDITION AGGRAVATED48 reports
PAIN IN EXTREMITY46 reports
DRUG HYPERSENSITIVITY45 reports
DYSPNOEA44 reports
RENAL FAILURE ACUTE44 reports
HYPOTENSION42 reports
FATIGUE41 reports
DIARRHOEA39 reports
HEADACHE39 reports
MUSCULOSKELETAL STIFFNESS39 reports
OFF LABEL USE39 reports
INFECTION38 reports
JOINT SWELLING38 reports
CEREBROVASCULAR ACCIDENT37 reports
NAUSEA36 reports
HYPERTENSION35 reports
PERIPHERAL SWELLING35 reports
RHEUMATOID ARTHRITIS35 reports
PYREXIA34 reports
ARTHROPATHY32 reports
DRUG DEPENDENCE32 reports
INCORRECT DRUG ADMINISTRATION DURATION32 reports
PNEUMONIA32 reports
CONFUSIONAL STATE31 reports
VOMITING31 reports
MOBILITY DECREASED28 reports
SINUSITIS28 reports
URTICARIA28 reports
HYPERSENSITIVITY27 reports
NASOPHARYNGITIS27 reports
WEIGHT DECREASED26 reports
GENERAL PHYSICAL HEALTH DETERIORATION25 reports
ABDOMINAL PAIN UPPER24 reports
DISABILITY24 reports
DYSPEPSIA24 reports
FOLLICULITIS24 reports
GASTROINTESTINAL DISORDER24 reports
MALAISE24 reports
PRURITUS24 reports
VISION BLURRED24 reports
BRADYCARDIA23 reports
RASH23 reports
STOMATITIS23 reports
TREATMENT FAILURE23 reports
WEIGHT INCREASED23 reports
BLOOD CHOLESTEROL INCREASED22 reports
CHEST PAIN22 reports
DECREASED APPETITE22 reports
GAIT DISTURBANCE22 reports
HYPOAESTHESIA22 reports
MATERNAL EXPOSURE DURING PREGNANCY22 reports
MEMORY IMPAIRMENT22 reports
MYOCARDIAL INFARCTION22 reports
NERVOUSNESS22 reports
ABDOMINAL DISCOMFORT21 reports
BLISTER21 reports
IMPAIRED HEALING21 reports
RHEUMATIC FEVER21 reports
SEPSIS21 reports
DRUG INTOLERANCE20 reports
DUODENAL ULCER PERFORATION20 reports
HELICOBACTER INFECTION20 reports
INFLAMMATION20 reports
LIVER INJURY20 reports
MUSCULOSKELETAL PAIN20 reports
SLEEP DISORDER20 reports
SWELLING20 reports
THERAPY NON RESPONDER20 reports
TYPE 2 DIABETES MELLITUS20 reports
WHEEZING20 reports
ALOPECIA19 reports
ANTERIOR CHAMBER CELL19 reports
CONTUSION19 reports
DIZZINESS19 reports
FIBROMYALGIA19 reports
GAIT INABILITY19 reports
GLOSSODYNIA19 reports
HEPATIC ENZYME INCREASED19 reports
HEPATOTOXICITY19 reports
INFUSION RELATED REACTION19 reports
IRRITABLE BOWEL SYNDROME19 reports
JOINT STIFFNESS19 reports
MUSCLE INJURY19 reports
SYNOVITIS19 reports

Report Outcomes

Out of 852 classified reports for PHENYLEPHRINE HCL:

Serious 83.5%Non-Serious 16.5%

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

Female422 (53.2%)
Male370 (46.7%)
Unknown1 (0.1%)

Reports by Age

Age 7122 reports
Age 6919 reports
Age 4217 reports
Age 6517 reports
Age 7316 reports
Age 5015 reports
Age 6215 reports
Age 6414 reports
Age 6714 reports
Age 6814 reports
Age 7214 reports
Age 7714 reports
Age 3513 reports
Age 7013 reports
Age 4812 reports
Age 5412 reports
Age 5912 reports
Age 7412 reports
Age 7612 reports
Age 8312 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 HCL?

This profile reflects 4,600 FDA FAERS reports that mention PHENYLEPHRINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PHENYLEPHRINE HCL?

Frequently reported terms in FAERS include PAIN, INJURY, RENAL FAILURE, ANXIETY, UNEVALUABLE EVENT, FEAR. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PHENYLEPHRINE HCL?

Labeling and FAERS entries often list Strategic Sourcing Services LLC in connection with PHENYLEPHRINE HCL. 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.