PSEUDOEPHEDRINE HYDROCHLORIDE

N/A

Manufactured by Kenvue Brands LLC

239,592 FDA adverse event reports analyzed

Last updated: 2026-04-14

About PSEUDOEPHEDRINE HYDROCHLORIDE

PSEUDOEPHEDRINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kenvue Brands LLC. The most commonly reported adverse reactions for PSEUDOEPHEDRINE HYDROCHLORIDE include SYSTEMIC LUPUS ERYTHEMATOSUS, PAIN, DRUG INEFFECTIVE, PEMPHIGUS, RHEUMATOID ARTHRITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PSEUDOEPHEDRINE HYDROCHLORIDE.

Top Adverse Reactions

SYSTEMIC LUPUS ERYTHEMATOSUS5,062 reports
PAIN5,007 reports
DRUG INEFFECTIVE4,987 reports
PEMPHIGUS4,947 reports
RHEUMATOID ARTHRITIS4,930 reports
ABDOMINAL DISCOMFORT4,840 reports
ALOPECIA4,782 reports
GLOSSODYNIA4,574 reports
FATIGUE4,429 reports
SWELLING4,417 reports
WOUND4,407 reports
RASH4,324 reports
HAND DEFORMITY4,321 reports
ARTHROPATHY4,081 reports
SYNOVITIS4,059 reports
PERICARDITIS4,058 reports
INFUSION RELATED REACTION3,901 reports
JOINT SWELLING3,810 reports
CONTRAINDICATED PRODUCT ADMINISTERED3,691 reports
HYPERSENSITIVITY3,677 reports
HEPATIC ENZYME INCREASED3,615 reports
DRUG INTOLERANCE3,601 reports
DISCOMFORT3,560 reports
MATERNAL EXPOSURE DURING PREGNANCY3,523 reports
OFF LABEL USE3,472 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE3,419 reports
PRODUCT USE ISSUE3,279 reports
DUODENAL ULCER PERFORATION2,917 reports
ARTHRALGIA2,906 reports
HELICOBACTER INFECTION2,858 reports
TREATMENT FAILURE2,847 reports
CONDITION AGGRAVATED2,734 reports
GENERAL PHYSICAL HEALTH DETERIORATION2,696 reports
THERAPEUTIC PRODUCT EFFECT DECREASED2,585 reports
RHEUMATOID FACTOR POSITIVE2,439 reports
TYPE 2 DIABETES MELLITUS2,439 reports
BLISTER2,435 reports
MUSCULOSKELETAL STIFFNESS2,318 reports
BLOOD CHOLESTEROL INCREASED2,236 reports
PSORIATIC ARTHROPATHY2,231 reports
RHEUMATIC FEVER2,198 reports
HYPERTENSION2,193 reports
HEADACHE2,166 reports
FOLLICULITIS2,138 reports
WEIGHT INCREASED2,097 reports
IRRITABLE BOWEL SYNDROME2,066 reports
CONFUSIONAL STATE2,057 reports
IMPAIRED HEALING2,047 reports
STOMATITIS2,023 reports
NASOPHARYNGITIS1,997 reports
INTENTIONAL PRODUCT USE ISSUE1,928 reports
MOBILITY DECREASED1,914 reports
PERIPHERAL SWELLING1,908 reports
VOMITING1,895 reports
MUSCLE INJURY1,883 reports
LOWER RESPIRATORY TRACT INFECTION1,851 reports
LIVER INJURY1,835 reports
INFECTION1,823 reports
INJURY1,800 reports
FIBROMYALGIA1,771 reports
HYPOAESTHESIA1,756 reports
PYREXIA1,724 reports
NAUSEA1,722 reports
DYSPNOEA1,703 reports
URTICARIA1,684 reports
DRUG HYPERSENSITIVITY1,657 reports
PRODUCT USE IN UNAPPROVED INDICATION1,649 reports
SWOLLEN JOINT COUNT INCREASED1,626 reports
SINUSITIS1,620 reports
GASTROINTESTINAL DISORDER1,604 reports
PRURITUS1,601 reports
DIARRHOEA1,586 reports
ILL DEFINED DISORDER1,486 reports
WHEEZING1,485 reports
DIZZINESS1,464 reports
ABDOMINAL PAIN UPPER1,451 reports
MALAISE1,450 reports
CONTUSION1,419 reports
DECREASED APPETITE1,406 reports
EXPOSURE DURING PREGNANCY1,393 reports
SLEEP DISORDER1,374 reports
SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE1,324 reports
PNEUMONIA1,283 reports
PAIN IN EXTREMITY1,239 reports
OSTEOARTHRITIS1,177 reports
JOINT RANGE OF MOTION DECREASED1,169 reports
DRY MOUTH1,127 reports
ASTHENIA1,114 reports
INSOMNIA1,114 reports
OEDEMA1,101 reports
GAIT INABILITY1,071 reports
ADVERSE EVENT1,032 reports
INFLAMMATION1,030 reports
MIGRAINE1,020 reports
BURSITIS1,000 reports
LIP DRY995 reports
WOUND INFECTION994 reports
CHEST PAIN991 reports
FACET JOINT SYNDROME982 reports
MEMORY IMPAIRMENT965 reports

Report Outcomes

Out of 9,450 classified reports for PSEUDOEPHEDRINE HYDROCHLORIDE:

Serious 88.6%Non-Serious 11.4%

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

Female7,126 (92.2%)
Male594 (7.7%)
Unknown6 (0.1%)

Reports by Age

Age 431,562 reports
Age 441,161 reports
Age 40628 reports
Age 59438 reports
Age 48122 reports
Age 5095 reports
Age 6276 reports
Age 5674 reports
Age 6063 reports
Age 4552 reports
Age 9750 reports
Age 7041 reports
Age 7539 reports
Age 6538 reports
Age 7136 reports
Age 2029 reports
Age 5328 reports
Age 4225 reports
Age 9625 reports
Age 3224 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 PSEUDOEPHEDRINE HYDROCHLORIDE?

This profile reflects 239,592 FDA FAERS reports that mention PSEUDOEPHEDRINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PSEUDOEPHEDRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include SYSTEMIC LUPUS ERYTHEMATOSUS, PAIN, DRUG INEFFECTIVE, PEMPHIGUS, RHEUMATOID ARTHRITIS, ABDOMINAL DISCOMFORT. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PSEUDOEPHEDRINE HYDROCHLORIDE?

Labeling and FAERS entries often list Kenvue Brands LLC in connection with PSEUDOEPHEDRINE 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.