METOLAZONE

N/A

Manufactured by Aarkish Pharmaceuticals NJ Inc.

29,146 FDA adverse event reports analyzed

Last updated: 2026-04-14

About METOLAZONE

METOLAZONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aarkish Pharmaceuticals NJ Inc.. The most commonly reported adverse reactions for METOLAZONE include DYSPNOEA, DEATH, ACUTE KIDNEY INJURY, NAUSEA, RENAL FAILURE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METOLAZONE.

Top Adverse Reactions

DYSPNOEA1,204 reports
DEATH866 reports
ACUTE KIDNEY INJURY790 reports
NAUSEA736 reports
RENAL FAILURE713 reports
CARDIAC FAILURE CONGESTIVE676 reports
FATIGUE648 reports
DIARRHOEA640 reports
DIZZINESS598 reports
CHRONIC KIDNEY DISEASE589 reports
HYPOTENSION578 reports
ASTHENIA571 reports
HEADACHE537 reports
OEDEMA PERIPHERAL525 reports
FALL507 reports
FLUID RETENTION489 reports
PNEUMONIA487 reports
PAIN427 reports
VOMITING388 reports
ANAEMIA383 reports
WEIGHT INCREASED383 reports
CARDIAC FAILURE367 reports
CONDITION AGGRAVATED365 reports
WEIGHT DECREASED345 reports
ATRIAL FIBRILLATION343 reports
MALAISE343 reports
DEHYDRATION341 reports
GASTROINTESTINAL HAEMORRHAGE330 reports
COUGH327 reports
CHEST PAIN325 reports
OEDEMA325 reports
PERIPHERAL SWELLING317 reports
END STAGE RENAL DISEASE315 reports
HYPOKALAEMIA314 reports
PAIN IN EXTREMITY312 reports
OFF LABEL USE301 reports
DRUG INEFFECTIVE295 reports
RENAL FAILURE ACUTE282 reports
BLOOD CREATININE INCREASED261 reports
ARTHRALGIA241 reports
DECREASED APPETITE239 reports
PYREXIA234 reports
FLUID OVERLOAD230 reports
BACK PAIN229 reports
SYNCOPE229 reports
URINARY TRACT INFECTION223 reports
BLOOD GLUCOSE INCREASED219 reports
RENAL IMPAIRMENT218 reports
CONSTIPATION215 reports
ANXIETY214 reports
HAEMOGLOBIN DECREASED214 reports
PULMONARY HYPERTENSION208 reports
HYPONATRAEMIA206 reports
CONFUSIONAL STATE201 reports
PULMONARY ARTERIAL HYPERTENSION199 reports
SEPSIS199 reports
RESPIRATORY FAILURE197 reports
HOSPITALISATION190 reports
BLOOD POTASSIUM DECREASED189 reports
DYSPNOEA EXERTIONAL187 reports
PRURITUS186 reports
DRUG INTERACTION182 reports
HYPERTENSION181 reports
FEELING ABNORMAL180 reports
CELLULITIS179 reports
CARDIAC ARREST178 reports
EPISTAXIS178 reports
ABDOMINAL DISTENSION174 reports
PULMONARY OEDEMA174 reports
ABDOMINAL PAIN171 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE171 reports
PLEURAL EFFUSION171 reports
LOSS OF CONSCIOUSNESS170 reports
GAIT DISTURBANCE169 reports
RASH169 reports
MYOCARDIAL INFARCTION164 reports
OXYGEN SATURATION DECREASED164 reports
HYPERKALAEMIA159 reports
TOXICITY TO VARIOUS AGENTS155 reports
MUSCLE SPASMS152 reports
NEPHROGENIC ANAEMIA152 reports
INSOMNIA147 reports
RIGHT VENTRICULAR FAILURE146 reports
CHEST DISCOMFORT145 reports
HYPOXIA144 reports
DEPRESSION143 reports
RENAL INJURY143 reports
SOMNOLENCE143 reports
PALPITATIONS141 reports
CARDIAC DISORDER135 reports
BLOOD PRESSURE DECREASED133 reports
ACUTE RESPIRATORY FAILURE131 reports
SWELLING131 reports
ABDOMINAL DISCOMFORT127 reports
RENAL DISORDER127 reports
MYALGIA125 reports
PAIN IN JAW123 reports
ERYTHEMA120 reports
TREMOR120 reports
INFECTION119 reports

Report Outcomes

Out of 10,862 classified reports for METOLAZONE:

Serious 79.8%Non-Serious 20.2%

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

Female5,394 (52.5%)
Male4,874 (47.4%)
Unknown14 (0.1%)

Reports by Age

Age 74260 reports
Age 73244 reports
Age 69241 reports
Age 64236 reports
Age 76227 reports
Age 68225 reports
Age 66223 reports
Age 67219 reports
Age 72209 reports
Age 70201 reports
Age 63198 reports
Age 62197 reports
Age 78192 reports
Age 79186 reports
Age 71183 reports
Age 65180 reports
Age 77180 reports
Age 75179 reports
Age 61176 reports
Age 60175 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 METOLAZONE?

This profile reflects 29,146 FDA FAERS reports that mention METOLAZONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for METOLAZONE?

Frequently reported terms in FAERS include DYSPNOEA, DEATH, ACUTE KIDNEY INJURY, NAUSEA, RENAL FAILURE, CARDIAC FAILURE CONGESTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures METOLAZONE?

Labeling and FAERS entries often list Aarkish Pharmaceuticals NJ Inc. in connection with METOLAZONE. 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.