OpenClaim

Midazolam Side Effects

The most commonly reported side effects of midazolam include off label use, seizure, and hypotension, based on 34,046 FDA adverse event reports from 2004 to 2025. 10.1% of reports found the drug to be ineffective.

Midazolam side effects

Percentages show how often each reaction appears relative to total reports for midazolam.

1
Drug Ineffective10.1%3,427
2
Off Label Use7.5%2,553
3
Seizure4.7%1,592
4
Hypotension4.4%1,506
5
Drug Interaction3.4%1,172
6
Renal Failure3.1%1,051
7
Acute Kidney Injury3.1%1,044
8
Pain3.0%1,030
9
Pyrexia3.0%1,008
10
Toxicity To Various Agents2.8%938
11
Injury2.7%909
12
Anxiety2.6%895
13
Cardiac Arrest2.5%868
14
Unevaluable Event2.5%835
15
Nausea2.2%766

These are voluntary reports and do not establish that midazolam caused these reactions.

Report severity

92.2%Serious31,387 reports
44.9%Hospitalizations15,298 reports
19.8%Fatal6,734 reports

Seriousness is determined by the reporter, not by OpenClaim.

Midazolam drug interactions

Other drugs that appear in adverse event reports alongside midazolam. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Propofol16.1%5,485
2
Fentanyl13.0%4,430
3
Levetiracetam10.3%3,492
4
Phenytoin5.8%1,980
5
Ketamine-hydrochloride5.5%1,869
6
Lacosamide5.2%1,761
7
Acetaminophen4.1%1,398
8
Diazepam4.1%1,391
9
Lorazepam4.1%1,382
10
Phenobarbital-sodium4.0%1,373
11
Sufentanil-citrate3.7%1,264
12
Lidocaine3.7%1,253
13
Rocuronium-bromide3.6%1,233
14
Methylprednisolone3.4%1,164
15
Sevoflurane3.4%1,149

Taken alongside

1
Fentanyl23.1%7,859
2
Propofol15.7%5,335
3
Acetaminophen14.6%4,975
4
Furosemide10.4%3,541
5
Heparin8.7%2,977
6
Epinephrine8.3%2,821
7
Lidocaine8.0%2,726
8
Ondansetron7.9%2,694
9
Dexamethasone7.1%2,412
10
Lorazepam7.0%2,381
11
Apomorphine-hydrochloride6.9%2,354
12
Vancomycin6.7%2,281
13
Pantoprazole-sodium6.4%2,166
14
Aspirin6.3%2,161
15
Insulin6.3%2,139

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports midazolam side effects

42.2% of midazolam adverse event reports involve female patients and 45.8% involve male patients. The largest age group is adult at 55%. These figures reflect who reports side effects, not underlying risk.

Sex

Female42.2%
Male45.8%
Unknown11.9%

Age group

< 25.9%
2–117.9%
12–174.9%
18–6454.9%
65+26.4%

What is midazolam used for

Conditions and purposes for which patients were taking midazolam when the adverse event was reported.

Abdominal DiscomfortAbdominal PainAbdominal Pain UpperAbnormal BehaviourAbscess DrainageAbscess NeckAccidental ExposureAccidental Exposure To ProductAccidental PoisoningAcute Encephalitis With Refractory, Repetitive Partial SeizuresAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAcute PsychosisAcute Pulmonary OedemaAcute Respiratory Distress Syndrome

Showing 15 of 1,067 indications

Midazolam brand names and reporting trend

Midazolam is sold under brand names including Midazolam In 0.8% Sodium Chloride, Seizalam.

Brand names

Midazolam In 0.8% Sodium Chloride35,275
Seizalam13

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking midazolam with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.