IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

N/A

Manufactured by Haleon US Holdings LLC

2,548 FDA adverse event reports analyzed

Last updated: 2026-04-15

About IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. The most commonly reported adverse reactions for IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE include DRUG INEFFECTIVE, NAUSEA, HEADACHE, DIZZINESS, CONDITION AGGRAVATED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE296 reports
NAUSEA64 reports
HEADACHE61 reports
DIZZINESS57 reports
CONDITION AGGRAVATED51 reports
INSOMNIA50 reports
ARTHRALGIA45 reports
FATIGUE45 reports
DYSPNOEA43 reports
OFF LABEL USE42 reports
JOINT SWELLING39 reports
PRODUCT USE IN UNAPPROVED INDICATION39 reports
MALAISE38 reports
PRURITUS38 reports
DRUG HYPERSENSITIVITY37 reports
FEELING ABNORMAL37 reports
PAIN37 reports
VOMITING37 reports
PAIN IN EXTREMITY36 reports
SOMNOLENCE36 reports
HYPERSENSITIVITY35 reports
MUSCULOSKELETAL STIFFNESS35 reports
DRUG INTOLERANCE34 reports
DIARRHOEA30 reports
RASH29 reports
THERAPEUTIC RESPONSE UNEXPECTED29 reports
ABDOMINAL PAIN UPPER27 reports
DRUG EFFECT INCOMPLETE27 reports
URTICARIA27 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION26 reports
PERIPHERAL SWELLING26 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE26 reports
INFECTION23 reports
MUSCULOSKELETAL PAIN23 reports
TREATMENT FAILURE23 reports
ANXIETY22 reports
ARTHROPATHY22 reports
NASOPHARYNGITIS22 reports
PALPITATIONS22 reports
DYSPHAGIA21 reports
PSORIATIC ARTHROPATHY21 reports
ABDOMINAL DISCOMFORT20 reports
ARTHRITIS20 reports
ASTHENIA20 reports
PRODUCT COMPLAINT20 reports
C REACTIVE PROTEIN ABNORMAL19 reports
COUGH19 reports
HEART RATE INCREASED19 reports
JOINT INJURY19 reports
JOINT STIFFNESS19 reports
NEOPLASM MALIGNANT19 reports
THERAPY NON RESPONDER19 reports
BLOOD PRESSURE INCREASED18 reports
GASTROINTESTINAL TOXICITY18 reports
HEPATOTOXICITY18 reports
PRODUCT USE ISSUE18 reports
PULMONARY TOXICITY18 reports
DEPRESSION17 reports
RHEUMATOID ARTHRITIS17 reports
BACK PAIN16 reports
FALL16 reports
SINUSITIS16 reports
SWELLING16 reports
EYE SWELLING15 reports
FEELING JITTERY15 reports
HYPERTENSION15 reports
HYPOAESTHESIA15 reports
INFLAMMATION15 reports
LIP SWELLING15 reports
OVERDOSE15 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS15 reports
CHEST PAIN14 reports
COVID 1914 reports
NASAL CONGESTION14 reports
RHINORRHOEA14 reports
SWELLING FACE14 reports
THERAPEUTIC PRODUCT EFFECT DECREASED14 reports
CHOKING13 reports
DYSGEUSIA13 reports
INTENTIONAL PRODUCT MISUSE13 reports
PYREXIA13 reports
TREMOR13 reports
CONSTIPATION12 reports
DECREASED APPETITE12 reports
DRUG INTERACTION12 reports
EPISTAXIS12 reports
INCORRECT DOSE ADMINISTERED12 reports
PRE EXISTING CONDITION IMPROVED12 reports
CONTRAINDICATED PRODUCT ADMINISTERED11 reports
DRUG EFFECT DECREASED11 reports
DRY SKIN11 reports
ERYTHEMA11 reports
EXPIRED PRODUCT ADMINISTERED11 reports
GAIT DISTURBANCE11 reports
INFLUENZA11 reports
WEIGHT DECREASED11 reports
DISEASE RECURRENCE10 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION10 reports
DRUG SCREEN POSITIVE10 reports
EXOSTOSIS10 reports

Report Outcomes

Out of 1,257 classified reports for IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE:

Serious 30.2%Non-Serious 69.8%

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

Female726 (66.6%)
Male319 (29.3%)
Unknown45 (4.1%)

Reports by Age

Age 4218 reports
Age 6018 reports
Age 5916 reports
Age 6215 reports
Age 6515 reports
Age 4514 reports
Age 4914 reports
Age 5514 reports
Age 6614 reports
Age 5713 reports
Age 7213 reports
Age 4612 reports
Age 5012 reports
Age 4311 reports
Age 5411 reports
Age 5811 reports
Age 5310 reports
Age 5610 reports
Age 6310 reports
Age 7310 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 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE?

This profile reflects 2,548 FDA FAERS reports that mention IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, NAUSEA, HEADACHE, DIZZINESS, CONDITION AGGRAVATED, INSOMNIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE?

Labeling and FAERS entries often list Haleon US Holdings LLC in connection with IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

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Drugs Also Linked to DRUG INEFFECTIVE

The following drugs share commonly reported adverse reactions with IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE:

0XYGENABACAVIR SULFATEABATACEPTABEMACICLIBABIRATERONE ACETATEACETAMINOPHENACETAMINOPHEN 500 MGACETAMINOPHEN 500MGACETAMINOPHEN AND CODEINEACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEACETAMINOPHEN AND IBUPROFENACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE

View all drugs reporting DRUG INEFFECTIVE →

Explore More

Safety RankingsSearch All DrugsCompare DrugsHaleon US Holdings LLC PortfolioDRUG INEFFECTIVE in Other DrugsNAUSEA in Other DrugsHEADACHE in Other Drugs
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.