MIDAZOLAM HYDROCHLORIDE

N/A

Manufactured by Fresenius Kabi USA, LLC

46,685 FDA adverse event reports analyzed

Last updated: 2026-04-14

About MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. The most commonly reported adverse reactions for MIDAZOLAM HYDROCHLORIDE include DRUG INEFFECTIVE, OFF LABEL USE, HYPOTENSION, DRUG INTERACTION, SEIZURE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MIDAZOLAM HYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE3,265 reports
OFF LABEL USE2,390 reports
HYPOTENSION1,514 reports
DRUG INTERACTION1,195 reports
SEIZURE1,103 reports
PYREXIA921 reports
TOXICITY TO VARIOUS AGENTS916 reports
CARDIAC ARREST906 reports
ACUTE KIDNEY INJURY893 reports
DEATH719 reports
RESPIRATORY FAILURE692 reports
CONDITION AGGRAVATED669 reports
NAUSEA668 reports
STATUS EPILEPTICUS662 reports
TACHYCARDIA645 reports
PRODUCT USE IN UNAPPROVED INDICATION625 reports
DYSPNOEA618 reports
ANAPHYLACTIC REACTION611 reports
PAIN610 reports
ANAEMIA593 reports
PNEUMONIA578 reports
VOMITING573 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION568 reports
BRADYCARDIA567 reports
AGITATION541 reports
SOMNOLENCE510 reports
ABDOMINAL PAIN509 reports
HYPOXIA507 reports
DIARRHOEA504 reports
OVERDOSE499 reports
SEROTONIN SYNDROME490 reports
RENAL FAILURE486 reports
OXYGEN SATURATION DECREASED477 reports
ANXIETY452 reports
THROMBOCYTOPENIA452 reports
HEADACHE443 reports
ERYTHEMA428 reports
CONSTIPATION424 reports
RHABDOMYOLYSIS422 reports
HYPERTENSION412 reports
METABOLIC ACIDOSIS406 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME405 reports
SEPSIS398 reports
MALAISE395 reports
RASH393 reports
DELIRIUM388 reports
FATIGUE369 reports
WEIGHT DECREASED369 reports
COMA361 reports
CONFUSIONAL STATE359 reports
COLITIS340 reports
LOSS OF CONSCIOUSNESS338 reports
GENERALISED TONIC CLONIC SEIZURE323 reports
DEPRESSED LEVEL OF CONSCIOUSNESS319 reports
RENAL IMPAIRMENT306 reports
SEPTIC SHOCK306 reports
ASTHENIA300 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE296 reports
ANAPHYLACTIC SHOCK290 reports
DRUG ABUSE288 reports
MULTIPLE DRUG RESISTANCE285 reports
RESPIRATORY DEPRESSION282 reports
DIZZINESS281 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS278 reports
UNRESPONSIVE TO STIMULI274 reports
DECREASED APPETITE271 reports
FOETAL EXPOSURE DURING PREGNANCY270 reports
MYOCLONUS269 reports
ALANINE AMINOTRANSFERASE INCREASED267 reports
MATERNAL EXPOSURE DURING PREGNANCY264 reports
PRODUCT USE ISSUE263 reports
INSOMNIA260 reports
COLITIS ULCERATIVE259 reports
CARDIO RESPIRATORY ARREST257 reports
GENERAL PHYSICAL HEALTH DETERIORATION252 reports
FREQUENT BOWEL MOVEMENTS248 reports
HYPOKALAEMIA248 reports
ENCEPHALOPATHY247 reports
HAEMATOCHEZIA241 reports
EPILEPSY240 reports
ARTHRALGIA239 reports
RECTAL HAEMORRHAGE237 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED229 reports
NO ADVERSE EVENT229 reports
BLOOD PRESSURE DECREASED227 reports
SHOCK227 reports
PULMONARY OEDEMA226 reports
ATRIAL FIBRILLATION225 reports
TREMOR222 reports
DEPRESSION220 reports
ELECTROCARDIOGRAM QT PROLONGED220 reports
RESPIRATORY ARREST219 reports
ACUTE RESPIRATORY DISTRESS SYNDROME218 reports
CARDIAC FAILURE217 reports
FALL217 reports
COUGH215 reports
CIRCULATORY COLLAPSE212 reports
INTENTIONAL OVERDOSE208 reports
ORAL CANDIDIASIS208 reports
URINARY TRACT INFECTION208 reports

Report Outcomes

Out of 25,766 classified reports for MIDAZOLAM HYDROCHLORIDE:

Serious 93.5%Non-Serious 6.5%

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

Male11,717 (51.8%)
Female10,750 (47.5%)
Unknown169 (0.7%)

Reports by Age

Age 65432 reports
Age 67417 reports
Age 60375 reports
Age 62359 reports
Age 75349 reports
Age 49348 reports
Age 58339 reports
Age 57320 reports
Age 63320 reports
Age 6314 reports
Age 71314 reports
Age 69309 reports
Age 31308 reports
Age 54305 reports
Age 64304 reports
Age 2298 reports
Age 72290 reports
Age 19289 reports
Age 66275 reports
Age 59268 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 MIDAZOLAM HYDROCHLORIDE?

This profile reflects 46,685 FDA FAERS reports that mention MIDAZOLAM HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MIDAZOLAM HYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, HYPOTENSION, DRUG INTERACTION, SEIZURE, PYREXIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MIDAZOLAM HYDROCHLORIDE?

Labeling and FAERS entries often list Fresenius Kabi USA, LLC in connection with MIDAZOLAM 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.