LORATADINE AND PSEUDOEPHEDRINE SULFATE

N/A

Manufactured by Bayer HealthCare LLC.

12,600 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LORATADINE AND PSEUDOEPHEDRINE SULFATE

LORATADINE AND PSEUDOEPHEDRINE SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare LLC.. The most commonly reported adverse reactions for LORATADINE AND PSEUDOEPHEDRINE SULFATE include DRUG INEFFECTIVE, INSOMNIA, DRUG EFFECT DECREASED, PRODUCT USE ISSUE, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LORATADINE AND PSEUDOEPHEDRINE SULFATE.

Top Adverse Reactions

DRUG INEFFECTIVE1,735 reports
INSOMNIA714 reports
DRUG EFFECT DECREASED454 reports
PRODUCT USE ISSUE382 reports
DIZZINESS374 reports
SOMNOLENCE292 reports
HEADACHE283 reports
NAUSEA278 reports
FATIGUE252 reports
DYSPNOEA231 reports
FEELING ABNORMAL217 reports
PALPITATIONS199 reports
DRY MOUTH188 reports
OFF LABEL USE183 reports
ANXIETY182 reports
PAIN166 reports
DIARRHOEA153 reports
FEELING JITTERY149 reports
MALAISE147 reports
HEART RATE INCREASED146 reports
VOMITING138 reports
BLOOD PRESSURE INCREASED136 reports
NERVOUSNESS126 reports
ASTHENIA124 reports
RASH122 reports
COUGH120 reports
PRODUCT USE IN UNAPPROVED INDICATION119 reports
EXTRA DOSE ADMINISTERED117 reports
HYPERSENSITIVITY117 reports
CONDITION AGGRAVATED115 reports
CHEST PAIN107 reports
THERAPEUTIC RESPONSE UNEXPECTED107 reports
UNEVALUABLE EVENT106 reports
ARTHRALGIA102 reports
CONSTIPATION102 reports
DEPRESSION101 reports
PRURITUS97 reports
POOR QUALITY SLEEP94 reports
OVERDOSE90 reports
SINUSITIS90 reports
INCORRECT DOSE ADMINISTERED89 reports
TREMOR89 reports
EXPIRED PRODUCT ADMINISTERED86 reports
PAIN IN EXTREMITY86 reports
ABDOMINAL PAIN UPPER83 reports
HYPERTENSION83 reports
RHINORRHOEA83 reports
DRUG EFFECT DELAYED82 reports
HYPERHIDROSIS82 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS82 reports
DYSURIA81 reports
ABDOMINAL DISCOMFORT76 reports
HYPOAESTHESIA76 reports
DECREASED APPETITE75 reports
DRUG EFFECT INCOMPLETE72 reports
ABDOMINAL PAIN70 reports
DRUG HYPERSENSITIVITY70 reports
NASAL CONGESTION70 reports
BACK PAIN69 reports
FALL69 reports
PYREXIA69 reports
WEIGHT DECREASED68 reports
WEIGHT INCREASED67 reports
MUSCLE SPASMS64 reports
PARAESTHESIA64 reports
PNEUMONIA64 reports
INJURY62 reports
VISION BLURRED59 reports
ASTHMA58 reports
CHEST DISCOMFORT57 reports
OEDEMA PERIPHERAL57 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION55 reports
INCORRECT PRODUCT ADMINISTRATION DURATION54 reports
CHILLS53 reports
NASOPHARYNGITIS53 reports
PULMONARY EMBOLISM52 reports
SLEEP DISORDER51 reports
ERYTHEMA50 reports
ACCIDENTAL OVERDOSE49 reports
CEREBROVASCULAR ACCIDENT49 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION49 reports
INJECTION SITE PAIN49 reports
URTICARIA49 reports
AGITATION48 reports
DEEP VEIN THROMBOSIS47 reports
EPISTAXIS47 reports
GASTROOESOPHAGEAL REFLUX DISEASE47 reports
OROPHARYNGEAL PAIN47 reports
CONFUSIONAL STATE46 reports
DYSPEPSIA46 reports
RESTLESSNESS46 reports
LOSS OF CONSCIOUSNESS45 reports
MYALGIA45 reports
DEHYDRATION44 reports
EMOTIONAL DISTRESS44 reports
EYE PRURITUS44 reports
MIGRAINE44 reports
THERAPEUTIC RESPONSE DECREASED44 reports
GAIT DISTURBANCE43 reports
PSYCHOMOTOR HYPERACTIVITY43 reports

Report Outcomes

Out of 7,844 classified reports for LORATADINE AND PSEUDOEPHEDRINE SULFATE:

Serious 20.6%Non-Serious 79.4%

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

Female5,082 (69.3%)
Male2,233 (30.4%)
Unknown22 (0.3%)

Reports by Age

Age 34102 reports
Age 3094 reports
Age 3794 reports
Age 6094 reports
Age 3290 reports
Age 5087 reports
Age 5887 reports
Age 3183 reports
Age 4483 reports
Age 6982 reports
Age 2681 reports
Age 6181 reports
Age 2580 reports
Age 3378 reports
Age 6478 reports
Age 4077 reports
Age 6374 reports
Age 2773 reports
Age 2973 reports
Age 3673 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 AND PSEUDOEPHEDRINE SULFATE?

This profile reflects 12,600 FDA FAERS reports that mention LORATADINE AND 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 AND PSEUDOEPHEDRINE SULFATE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, INSOMNIA, DRUG EFFECT DECREASED, PRODUCT USE ISSUE, DIZZINESS, SOMNOLENCE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LORATADINE AND PSEUDOEPHEDRINE SULFATE?

Labeling and FAERS entries often list Bayer HealthCare LLC. in connection with LORATADINE AND 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.