LABETALOL HYDROCHLORIDE

N/A

Manufactured by Par Health USA, LLC

9,779 FDA adverse event reports analyzed

Last updated: 2026-04-15

About LABETALOL HYDROCHLORIDE

LABETALOL HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Par Health USA, LLC. The most commonly reported adverse reactions for LABETALOL HYDROCHLORIDE include NAUSEA, DRUG INEFFECTIVE, FATIGUE, HYPERTENSION, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LABETALOL HYDROCHLORIDE.

Top Adverse Reactions

NAUSEA290 reports
DRUG INEFFECTIVE287 reports
FATIGUE285 reports
HYPERTENSION280 reports
DIARRHOEA234 reports
DYSPNOEA227 reports
HEADACHE210 reports
MATERNAL EXPOSURE DURING PREGNANCY204 reports
PAIN204 reports
PREMATURE BABY195 reports
ASTHENIA188 reports
VOMITING181 reports
HYPOTENSION180 reports
DIZZINESS161 reports
FOETAL EXPOSURE DURING PREGNANCY157 reports
BLOOD PRESSURE INCREASED153 reports
ANXIETY142 reports
DEATH133 reports
OFF LABEL USE131 reports
FALL130 reports
RENAL FAILURE125 reports
OEDEMA PERIPHERAL124 reports
DRUG EXPOSURE DURING PREGNANCY120 reports
PNEUMONIA117 reports
CEREBROVASCULAR ACCIDENT116 reports
ARTHRALGIA109 reports
MALAISE106 reports
ANAEMIA104 reports
PAIN IN EXTREMITY104 reports
PYREXIA101 reports
ABDOMINAL PAIN100 reports
RASH98 reports
CARDIAC ARREST97 reports
WEIGHT DECREASED97 reports
PRURITUS95 reports
PREMATURE DELIVERY93 reports
COUGH90 reports
LOW BIRTH WEIGHT BABY90 reports
BACK PAIN88 reports
DEPRESSION87 reports
MYOCARDIAL INFARCTION86 reports
CHEST PAIN85 reports
URINARY TRACT INFECTION84 reports
EXPOSURE DURING PREGNANCY83 reports
CARDIAC FAILURE CONGESTIVE82 reports
DECREASED APPETITE82 reports
CONSTIPATION81 reports
RENAL FAILURE ACUTE80 reports
MUSCLE SPASMS77 reports
CAESAREAN SECTION76 reports
CONDITION AGGRAVATED76 reports
ABDOMINAL DISCOMFORT75 reports
ABDOMINAL PAIN UPPER75 reports
DRUG HYPERSENSITIVITY72 reports
BLOOD GLUCOSE INCREASED70 reports
INJURY70 reports
INSOMNIA69 reports
HYPERHIDROSIS68 reports
DEHYDRATION67 reports
HAEMOGLOBIN DECREASED67 reports
HYPOAESTHESIA67 reports
FEELING ABNORMAL66 reports
SOMNOLENCE66 reports
PRODUCT DOSE OMISSION ISSUE65 reports
VISION BLURRED65 reports
BLOOD CREATININE INCREASED64 reports
LOSS OF CONSCIOUSNESS64 reports
RESPIRATORY FAILURE63 reports
ATRIAL FIBRILLATION62 reports
EMOTIONAL DISTRESS62 reports
WEIGHT INCREASED62 reports
SEPSIS60 reports
CHRONIC KIDNEY DISEASE59 reports
PERIPHERAL SWELLING58 reports
BRADYCARDIA57 reports
DRUG INTERACTION56 reports
PRODUCT USE ISSUE56 reports
PULMONARY OEDEMA56 reports
COMPLETED SUICIDE55 reports
CONTUSION55 reports
MUSCULAR WEAKNESS55 reports
RENAL IMPAIRMENT55 reports
GAIT DISTURBANCE54 reports
ACUTE KIDNEY INJURY53 reports
TACHYCARDIA53 reports
TREATMENT NONCOMPLIANCE53 reports
PREGNANCY52 reports
CONFUSIONAL STATE51 reports
MYALGIA51 reports
MOBILITY DECREASED50 reports
UNEVALUABLE EVENT50 reports
BLOOD PRESSURE DECREASED49 reports
PALPITATIONS49 reports
DIABETES MELLITUS48 reports
PRE ECLAMPSIA48 reports
FLUSHING47 reports
PARAESTHESIA47 reports
ANHEDONIA46 reports
CORONARY ARTERY DISEASE46 reports
MEDICATION ERROR46 reports

Report Outcomes

Out of 4,652 classified reports for LABETALOL HYDROCHLORIDE:

Serious 71.5%Non-Serious 28.5%

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

Female2,671 (61.3%)
Male1,680 (38.5%)
Unknown9 (0.2%)

Reports by Age

Age 7872 reports
Age 7566 reports
Age 6564 reports
Age 6462 reports
Age 7458 reports
Age 6657 reports
Age 6757 reports
Age 5656 reports
Age 7156 reports
Age 6955 reports
Age 7654 reports
Age 5953 reports
Age 5552 reports
Age 3251 reports
Age 6850 reports
Age 7048 reports
Age 6246 reports
Age 6345 reports
Age 7745 reports
Age 7244 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 LABETALOL HYDROCHLORIDE?

This profile reflects 9,779 FDA FAERS reports that mention LABETALOL HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LABETALOL HYDROCHLORIDE?

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

Who manufactures LABETALOL HYDROCHLORIDE?

Labeling and FAERS entries often list Par Health USA, LLC in connection with LABETALOL 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.