LORATADINE, PSEUDOEPHEDRINE SULFATE

N/A

Manufactured by Padagis Israel Pharmaceuticals Ltd

701 FDA adverse event reports analyzed

Last updated: 2026-04-15

About LORATADINE, PSEUDOEPHEDRINE SULFATE

LORATADINE, PSEUDOEPHEDRINE SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Padagis Israel Pharmaceuticals Ltd. The most commonly reported adverse reactions for LORATADINE, PSEUDOEPHEDRINE SULFATE include PAIN, PRURITUS, HEADACHE, COVID-19, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LORATADINE, PSEUDOEPHEDRINE SULFATE.

Top Adverse Reactions

PAIN23 reports
PRURITUS19 reports
HEADACHE18 reports
COVID 1917 reports
DIARRHOEA17 reports
FATIGUE17 reports
COUGH16 reports
PNEUMONIA16 reports
DRUG INEFFECTIVE15 reports
NAUSEA15 reports
MALAISE14 reports
OFF LABEL USE14 reports
DIZZINESS13 reports
DYSPNOEA13 reports
SINUSITIS13 reports
CONSTIPATION12 reports
FALL12 reports
PRODUCT DOSE OMISSION ISSUE12 reports
PRODUCT USE IN UNAPPROVED INDICATION12 reports
RASH12 reports
WEIGHT DECREASED11 reports
ARTHRALGIA10 reports
NASOPHARYNGITIS10 reports
PAIN IN EXTREMITY10 reports
ASTHENIA9 reports
PRODUCT USE ISSUE9 reports
DEATH8 reports
DRY SKIN8 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION8 reports
INJECTION SITE PAIN8 reports
INSOMNIA8 reports
SOMNOLENCE8 reports
ATRIAL FIBRILLATION7 reports
CONDITION AGGRAVATED7 reports
RHINORRHOEA7 reports
SINUS DISORDER7 reports
WEIGHT INCREASED7 reports
ABDOMINAL DISCOMFORT6 reports
BACK PAIN6 reports
ERYTHEMA6 reports
FEELING ABNORMAL6 reports
ILLNESS6 reports
INCORRECT DOSE ADMINISTERED6 reports
INFECTION6 reports
INFLUENZA6 reports
STRESS6 reports
URINARY TRACT INFECTION6 reports
BLOOD PRESSURE INCREASED5 reports
DEPRESSION5 reports
ECZEMA5 reports
HERPES ZOSTER5 reports
HYPERSENSITIVITY5 reports
HYPERTENSION5 reports
HYPOTENSION5 reports
MOBILITY DECREASED5 reports
MULTIPLE ALLERGIES5 reports
PERIPHERAL SWELLING5 reports
STAPHYLOCOCCAL INFECTION5 reports
VOMITING5 reports
ABDOMINAL DISTENSION4 reports
ASTHMA4 reports
BONE PAIN4 reports
EYE PRURITUS4 reports
FLUID RETENTION4 reports
FLUSHING4 reports
INFUSION RELATED REACTION4 reports
NEUROPATHY PERIPHERAL4 reports
OROPHARYNGEAL PAIN4 reports
PRODUCT DISTRIBUTION ISSUE4 reports
PYREXIA4 reports
SKIN EXFOLIATION4 reports
SKIN FISSURES4 reports
SURGERY4 reports
THROMBOSIS4 reports
UPPER RESPIRATORY TRACT INFECTION4 reports
ABDOMINAL PAIN3 reports
ARTHRITIS3 reports
BLOOD GLUCOSE INCREASED3 reports
CARDIAC DISORDER3 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE3 reports
CYSTIC FIBROSIS3 reports
DECREASED APPETITE3 reports
DEHYDRATION3 reports
DEVICE RELATED INFECTION3 reports
DISCOMFORT3 reports
DRUG HYPERSENSITIVITY3 reports
DRUG INTOLERANCE3 reports
DYSPHONIA3 reports
FEELING HOT3 reports
FULL BLOOD COUNT DECREASED3 reports
GASTROINTESTINAL DISORDER3 reports
HAEMOGLOBIN DECREASED3 reports
HYPOAESTHESIA3 reports
INFUSION SITE PAIN3 reports
INSURANCE ISSUE3 reports
INTESTINAL OBSTRUCTION3 reports
LIMB INJURY3 reports
LUNG NEOPLASM MALIGNANT3 reports
MIGRAINE3 reports
MUSCULAR WEAKNESS3 reports

Report Outcomes

Out of 316 classified reports for LORATADINE, PSEUDOEPHEDRINE SULFATE:

Serious 44.9%Non-Serious 55.1%

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

Female180 (61.2%)
Male113 (38.4%)
Unknown1 (0.3%)

Reports by Age

Age 6111 reports
Age 669 reports
Age 576 reports
Age 586 reports
Age 596 reports
Age 635 reports
Age 725 reports
Age 654 reports
Age 754 reports
Age 393 reports
Age 413 reports
Age 423 reports
Age 463 reports
Age 483 reports
Age 503 reports
Age 533 reports
Age 623 reports
Age 643 reports
Age 683 reports
Age 793 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 LORATADINE, PSEUDOEPHEDRINE SULFATE?

This profile reflects 701 FDA FAERS reports that mention LORATADINE, PSEUDOEPHEDRINE SULFATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LORATADINE, PSEUDOEPHEDRINE SULFATE?

Frequently reported terms in FAERS include PAIN, PRURITUS, HEADACHE, COVID-19, DIARRHOEA, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LORATADINE, PSEUDOEPHEDRINE SULFATE?

Labeling and FAERS entries often list Padagis Israel Pharmaceuticals Ltd in connection with LORATADINE, PSEUDOEPHEDRINE SULFATE. 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.