PSEUDOEPHEDRINE HCL

N/A

Manufactured by Major Pharmaceuticals

242,486 FDA adverse event reports analyzed

Last updated: 2026-04-14

About PSEUDOEPHEDRINE HCL

PSEUDOEPHEDRINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Major Pharmaceuticals. The most commonly reported adverse reactions for PSEUDOEPHEDRINE HCL 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 HCL.

Top Adverse Reactions

SYSTEMIC LUPUS ERYTHEMATOSUS5,176 reports
PAIN5,160 reports
DRUG INEFFECTIVE5,120 reports
PEMPHIGUS5,060 reports
RHEUMATOID ARTHRITIS5,045 reports
ABDOMINAL DISCOMFORT4,955 reports
ALOPECIA4,900 reports
GLOSSODYNIA4,622 reports
FATIGUE4,519 reports
SWELLING4,457 reports
WOUND4,453 reports
RASH4,392 reports
HAND DEFORMITY4,365 reports
ARTHROPATHY4,109 reports
PERICARDITIS4,104 reports
SYNOVITIS4,098 reports
INFUSION RELATED REACTION3,938 reports
JOINT SWELLING3,859 reports
CONTRAINDICATED PRODUCT ADMINISTERED3,733 reports
HYPERSENSITIVITY3,729 reports
HEPATIC ENZYME INCREASED3,651 reports
DRUG INTOLERANCE3,638 reports
MATERNAL EXPOSURE DURING PREGNANCY3,602 reports
DISCOMFORT3,599 reports
OFF LABEL USE3,491 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE3,452 reports
PRODUCT USE ISSUE3,305 reports
ARTHRALGIA2,958 reports
DUODENAL ULCER PERFORATION2,924 reports
TREATMENT FAILURE2,894 reports
HELICOBACTER INFECTION2,867 reports
CONDITION AGGRAVATED2,768 reports
GENERAL PHYSICAL HEALTH DETERIORATION2,721 reports
THERAPEUTIC PRODUCT EFFECT DECREASED2,620 reports
RHEUMATOID FACTOR POSITIVE2,473 reports
TYPE 2 DIABETES MELLITUS2,456 reports
BLISTER2,442 reports
MUSCULOSKELETAL STIFFNESS2,357 reports
BLOOD CHOLESTEROL INCREASED2,256 reports
PSORIATIC ARTHROPATHY2,234 reports
HYPERTENSION2,228 reports
HEADACHE2,223 reports
RHEUMATIC FEVER2,209 reports
FOLLICULITIS2,139 reports
WEIGHT INCREASED2,110 reports
CONFUSIONAL STATE2,075 reports
IRRITABLE BOWEL SYNDROME2,067 reports
IMPAIRED HEALING2,055 reports
STOMATITIS2,022 reports
NASOPHARYNGITIS2,007 reports
INTENTIONAL PRODUCT USE ISSUE1,941 reports
VOMITING1,928 reports
MOBILITY DECREASED1,925 reports
PERIPHERAL SWELLING1,908 reports
MUSCLE INJURY1,884 reports
LOWER RESPIRATORY TRACT INFECTION1,854 reports
LIVER INJURY1,838 reports
INFECTION1,834 reports
INJURY1,816 reports
HYPOAESTHESIA1,779 reports
FIBROMYALGIA1,773 reports
NAUSEA1,767 reports
PYREXIA1,745 reports
DYSPNOEA1,726 reports
DRUG HYPERSENSITIVITY1,694 reports
URTICARIA1,689 reports
PRODUCT USE IN UNAPPROVED INDICATION1,645 reports
SINUSITIS1,639 reports
SWOLLEN JOINT COUNT INCREASED1,636 reports
PRURITUS1,616 reports
DIARRHOEA1,614 reports
GASTROINTESTINAL DISORDER1,605 reports
DIZZINESS1,509 reports
ILL DEFINED DISORDER1,493 reports
WHEEZING1,488 reports
MALAISE1,481 reports
ABDOMINAL PAIN UPPER1,470 reports
DECREASED APPETITE1,428 reports
CONTUSION1,422 reports
EXPOSURE DURING PREGNANCY1,412 reports
SLEEP DISORDER1,381 reports
SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE1,324 reports
PNEUMONIA1,319 reports
PAIN IN EXTREMITY1,260 reports
OSTEOARTHRITIS1,189 reports
JOINT RANGE OF MOTION DECREASED1,169 reports
ASTHENIA1,154 reports
DRY MOUTH1,131 reports
INSOMNIA1,131 reports
OEDEMA1,111 reports
GAIT INABILITY1,069 reports
ADVERSE EVENT1,038 reports
INFLAMMATION1,033 reports
MIGRAINE1,028 reports
CHEST PAIN1,007 reports
BURSITIS1,002 reports
LIP DRY995 reports
WOUND INFECTION994 reports
FACET JOINT SYNDROME982 reports
MEMORY IMPAIRMENT973 reports

Report Outcomes

Out of 10,408 classified reports for PSEUDOEPHEDRINE HCL:

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

Female7,635 (88.7%)
Male947 (11.0%)
Unknown23 (0.3%)

Reports by Age

Age 431,579 reports
Age 441,171 reports
Age 40636 reports
Age 59473 reports
Age 48132 reports
Age 50106 reports
Age 6289 reports
Age 5686 reports
Age 6080 reports
Age 4562 reports
Age 9750 reports
Age 5847 reports
Age 7045 reports
Age 1744 reports
Age 6543 reports
Age 5742 reports
Age 7540 reports
Age 339 reports
Age 7139 reports
Age 2037 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 HCL?

This profile reflects 242,486 FDA FAERS reports that mention PSEUDOEPHEDRINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PSEUDOEPHEDRINE HCL?

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 HCL?

Labeling and FAERS entries often list Major Pharmaceuticals in connection with PSEUDOEPHEDRINE 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.