GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

N/A

Manufactured by RB Health (US) LLC

3,854 FDA adverse event reports analyzed

Last updated: 2026-04-15

About GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

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

Top Adverse Reactions

DRUG INEFFECTIVE168 reports
INSOMNIA165 reports
DIZZINESS135 reports
HEADACHE117 reports
NAUSEA115 reports
FATIGUE103 reports
DYSPNOEA86 reports
ACCIDENTAL OVERDOSE76 reports
COUGH71 reports
SINUSITIS70 reports
DIARRHOEA69 reports
PAIN68 reports
ANXIETY66 reports
OVERDOSE64 reports
VOMITING63 reports
BLOOD PRESSURE INCREASED58 reports
OFF LABEL USE57 reports
RASH56 reports
FEELING ABNORMAL54 reports
HEART RATE INCREASED54 reports
INCORRECT DRUG ADMINISTRATION DURATION53 reports
NASOPHARYNGITIS52 reports
PALPITATIONS48 reports
ARTHRALGIA46 reports
BRONCHITIS46 reports
MALAISE45 reports
PNEUMONIA44 reports
COVID 1943 reports
PRURITUS41 reports
CONDITION AGGRAVATED38 reports
ASTHENIA37 reports
FALL37 reports
HYPERSENSITIVITY37 reports
PRODUCT USE IN UNAPPROVED INDICATION36 reports
PYREXIA36 reports
SOMNOLENCE36 reports
ABDOMINAL PAIN UPPER35 reports
NO ADVERSE EVENT34 reports
EPISTAXIS33 reports
NERVOUSNESS33 reports
WEIGHT DECREASED33 reports
MUSCLE SPASMS32 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION31 reports
CONSTIPATION30 reports
DEATH30 reports
URINARY TRACT INFECTION30 reports
DYSURIA29 reports
EXPIRED PRODUCT ADMINISTERED29 reports
HYPERHIDROSIS29 reports
PAIN IN EXTREMITY29 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS29 reports
ERYTHEMA28 reports
HYPERTENSION28 reports
CHEST DISCOMFORT27 reports
CHEST PAIN26 reports
RHINORRHOEA26 reports
TREMOR26 reports
URTICARIA26 reports
ASTHMA25 reports
INCORRECT PRODUCT ADMINISTRATION DURATION25 reports
OROPHARYNGEAL PAIN25 reports
BACK PAIN24 reports
DECREASED APPETITE24 reports
DEPRESSION24 reports
HYPOAESTHESIA24 reports
PERIPHERAL SWELLING24 reports
PRODUCT USE ISSUE24 reports
UPPER RESPIRATORY TRACT INFECTION24 reports
DRY MOUTH23 reports
MYALGIA23 reports
NASAL CONGESTION23 reports
PARAESTHESIA23 reports
UNDERDOSE23 reports
DISEASE RECURRENCE22 reports
ABDOMINAL DISCOMFORT21 reports
INFLUENZA21 reports
ANAEMIA19 reports
CHILLS19 reports
FEELING JITTERY19 reports
MIGRAINE19 reports
PRODUCT DOSE OMISSION ISSUE19 reports
HALLUCINATION18 reports
PRODUCTIVE COUGH18 reports
ABDOMINAL PAIN17 reports
CONTUSION17 reports
RESTLESSNESS17 reports
VISION BLURRED17 reports
WEIGHT INCREASED17 reports
DRUG HYPERSENSITIVITY16 reports
DEHYDRATION15 reports
DRY SKIN15 reports
INFECTION15 reports
BALANCE DISORDER14 reports
CONFUSIONAL STATE14 reports
DISCOMFORT14 reports
DYSGEUSIA14 reports
ILLNESS14 reports
NEUROPATHY PERIPHERAL14 reports
SLEEP DISORDER14 reports
VISUAL IMPAIRMENT14 reports

Report Outcomes

Out of 1,890 classified reports for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE:

Serious 36.7%Non-Serious 63.3%

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

Female1,238 (66.9%)
Male613 (33.1%)

Reports by Age

Age 6840 reports
Age 6733 reports
Age 6332 reports
Age 6532 reports
Age 6231 reports
Age 6629 reports
Age 7128 reports
Age 7628 reports
Age 5527 reports
Age 7227 reports
Age 6025 reports
Age 7025 reports
Age 5224 reports
Age 5724 reports
Age 5924 reports
Age 6124 reports
Age 5623 reports
Age 6423 reports
Age 6923 reports
Age 7722 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 GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE?

This profile reflects 3,854 FDA FAERS reports that mention GUAIFENESIN 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 GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE?

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

Who manufactures GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE?

Labeling and FAERS entries often list RB Health (US) LLC in connection with GUAIFENESIN AND 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.