MIDAZOLAM

N/A

Manufactured by UCB, Inc.

42,629 FDA adverse event reports analyzed

Last updated: 2026-04-14

About MIDAZOLAM

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

Top Adverse Reactions

DRUG INEFFECTIVE2,985 reports
OFF LABEL USE2,237 reports
SEIZURE1,373 reports
HYPOTENSION1,295 reports
DRUG INTERACTION1,089 reports
TOXICITY TO VARIOUS AGENTS846 reports
ACUTE KIDNEY INJURY845 reports
PYREXIA813 reports
CARDIAC ARREST811 reports
DEATH689 reports
STATUS EPILEPTICUS629 reports
RESPIRATORY FAILURE614 reports
CONDITION AGGRAVATED601 reports
TACHYCARDIA583 reports
PRODUCT USE IN UNAPPROVED INDICATION568 reports
DYSPNOEA560 reports
NAUSEA556 reports
ANAPHYLACTIC REACTION555 reports
PNEUMONIA543 reports
PAIN540 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION539 reports
ANAEMIA517 reports
AGITATION509 reports
OVERDOSE505 reports
BRADYCARDIA499 reports
VOMITING498 reports
SOMNOLENCE478 reports
DIARRHOEA469 reports
HYPOXIA449 reports
RENAL FAILURE449 reports
SEROTONIN SYNDROME442 reports
ABDOMINAL PAIN428 reports
ANXIETY424 reports
THROMBOCYTOPENIA415 reports
OXYGEN SATURATION DECREASED397 reports
RHABDOMYOLYSIS391 reports
METABOLIC ACIDOSIS387 reports
HYPERTENSION378 reports
HEADACHE376 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME376 reports
SEPSIS367 reports
FATIGUE365 reports
RASH361 reports
DELIRIUM352 reports
ERYTHEMA351 reports
CONSTIPATION349 reports
WEIGHT DECREASED348 reports
MALAISE335 reports
COMA328 reports
GENERALISED TONIC CLONIC SEIZURE325 reports
CONFUSIONAL STATE316 reports
LOSS OF CONSCIOUSNESS302 reports
DEPRESSED LEVEL OF CONSCIOUSNESS287 reports
SEPTIC SHOCK286 reports
ASTHENIA278 reports
MULTIPLE DRUG RESISTANCE275 reports
RENAL IMPAIRMENT272 reports
INSOMNIA270 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS267 reports
DRUG ABUSE262 reports
PRODUCT USE ISSUE262 reports
DECREASED APPETITE260 reports
NO ADVERSE EVENT258 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE254 reports
FOETAL EXPOSURE DURING PREGNANCY253 reports
COLITIS251 reports
RESPIRATORY DEPRESSION250 reports
UNRESPONSIVE TO STIMULI249 reports
ANAPHYLACTIC SHOCK247 reports
MATERNAL EXPOSURE DURING PREGNANCY241 reports
CARDIO RESPIRATORY ARREST240 reports
MYOCLONUS234 reports
DIZZINESS231 reports
EPILEPSY224 reports
GENERAL PHYSICAL HEALTH DETERIORATION223 reports
FALL221 reports
DEPRESSION219 reports
HYPOKALAEMIA217 reports
ALANINE AMINOTRANSFERASE INCREASED215 reports
URINARY TRACT INFECTION213 reports
ATRIAL FIBRILLATION207 reports
ELECTROCARDIOGRAM QT PROLONGED206 reports
ENCEPHALOPATHY206 reports
CARDIAC FAILURE204 reports
ACUTE RESPIRATORY DISTRESS SYNDROME203 reports
COUGH203 reports
SHOCK202 reports
TREMOR201 reports
BLOOD PRESSURE DECREASED200 reports
ARTHRALGIA195 reports
COLITIS ULCERATIVE195 reports
CIRCULATORY COLLAPSE191 reports
DRUG HYPERSENSITIVITY191 reports
FEBRILE NEUTROPENIA191 reports
PULMONARY OEDEMA191 reports
INTENTIONAL OVERDOSE188 reports
RESPIRATORY ARREST187 reports
BRAIN OEDEMA184 reports
FREQUENT BOWEL MOVEMENTS184 reports
URTICARIA184 reports

Report Outcomes

Out of 24,017 classified reports for MIDAZOLAM:

Serious 93.0%Non-Serious 7.0%

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

Male10,858 (51.7%)
Female9,983 (47.5%)
Unknown160 (0.8%)

Reports by Age

Age 65396 reports
Age 67369 reports
Age 60355 reports
Age 62336 reports
Age 75320 reports
Age 58303 reports
Age 6300 reports
Age 49299 reports
Age 57297 reports
Age 63293 reports
Age 71288 reports
Age 2281 reports
Age 54281 reports
Age 64279 reports
Age 31278 reports
Age 69277 reports
Age 19264 reports
Age 72260 reports
Age 73248 reports
Age 59247 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?

This profile reflects 42,629 FDA FAERS reports that mention MIDAZOLAM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MIDAZOLAM?

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

Who manufactures MIDAZOLAM?

Labeling and FAERS entries often list UCB, Inc. in connection with MIDAZOLAM. 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.