Prescription medication · Benzodiazepine
midazolam
Also sold as Versed. Midazolam is used to sedate you before a surgery or procedure to help you relax and feel less anxious.
Data updated 2026-05-15
- 24,014
- FDA reportsModerately reported
- 39
- InteractionsSeveral interactions
- In shortage
- FDA status
What the data shows
midazolam (Versed) is a prescription Benzodiazepine, reported at a middle-of-the-pack volume (24,014 FDA reports), with 39 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
midazolam (Versed) is a prescription Benzodiazepine. Midazolam is used to sedate you before a surgery or procedure to help you relax and feel less anxious.
Midazolam is a medicine that makes you feel calm, relaxed, and sleepy. It can also cause you to forget things that happen while you are taking it.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
midazolam is currently listed as in shortage by the FDA. Affected manufacturer: Gland Pharma Limited. Status: Unavailable.
View all drug shortages →Drug Pricing (NADAC)
Generic Price
$0.61/unit
Generic Available
Yes (17 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Midazolam is used to sedate you before a surgery or procedure to help you relax and feel less anxious.
Common side effects
Decreased breathing rate, Tenderness at the injection site, Pain during injection
Key warnings
Midazolam can cause serious breathing problems, including slowed or stopped breathing.
The sections below are summarized in plain English from midazolam's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Midazolam belongs to a class of drugs called benzodiazepines. It works by slowing down activity in your brain and nervous system. This helps to reduce anxiety, promote relaxation, and cause sleepiness.
Side Effects (from patient reports)
Based on 24,014 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for midazolam, by number of reports
- Seizure
Seizure
1,373 reports
- Hypotension
Hypotension
1,296 reports
- Drug Interaction
Drug Interaction
1,088 reports
- Toxicity To Various Agents
Toxicity To Various Agents
846 reports
- Acute Kidney Injury
Acute Kidney Injury
845 reports
- Pyrexia
Pyrexia
813 reports
- Cardiac Arrest
Cardiac Arrest
811 reports
- Death
Death
689 reports
- Status Epilepticus
Status Epilepticus
629 reports
- Respiratory Failure
Respiratory Failure
614 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for midazolam each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where midazolam sits
midazolam has more FDA adverse-event reports than 59% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is midazolam; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 24,014 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
24,014
Reports Mentioning Death
4,573
19.0% of reports — not proof of cause
Hospitalization Reports
11,054
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 3 | SEIZURE | 1,373 |
| 4 | HYPOTENSION | 1,296 |
| 5 | DRUG INTERACTION | 1,088 |
| 6 | TOXICITY TO VARIOUS AGENTS | 846 |
| 7 | ACUTE KIDNEY INJURY | 845 |
| 8 | PYREXIA | 813 |
| 9 | CARDIAC ARREST | 811 |
| 10 | DEATH | 689 |
| 11 | STATUS EPILEPTICUS | 629 |
| 12 | RESPIRATORY FAILURE | 614 |
| 13 | CONDITION AGGRAVATED | 601 |
| 14 | TACHYCARDIA | 583 |
| 16 | DYSPNOEA | 560 |
| 17 | NAUSEA | 556 |
| 18 | ANAPHYLACTIC REACTION | 555 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Midazolam can cause serious breathing problems, including slowed or stopped breathing. This is more likely to happen if you are also taking opioid pain medicines. You must be closely monitored by trained medical staff while receiving midazolam. Make sure the facility has the equipment and medicines needed to treat breathing problems immediately.
Known Drug Interactions
Sedatives/hypnotics: orally administered midazolam, triazolam ↑ midazolam ↑ triazolam Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression. Triazolam and orally administered midazolam are extensively metabolized by CYP3A. Co-administration of triazolam or orally administered midazolam with darunavir may cause large increases in the concentrations of these benzodiazepines.
Mechanism: Darunavir blocks the enzyme that breaks down midazolam, causing the sedative to build up in your body. This can lead to dangerously deep sleep or breathing problems.
Antipsychotics, Anxiolytics and Hypnotics Alprazolam a Midazolam (IV) a Aripiprazole a Quetiapine Buspirone a Cariprazine Ramelteon Diazepam a Risperidone a Haloperidol a Suvorexant Monitor for adverse reactions. Lurasidone Midazolam (oral) a Pimozide Triazolam a Contraindicated during and 2 weeks after itraconazole treatment.
Mechanism: Itraconazole blocks the breakdown of midazolam, making its calming effects much stronger and potentially dangerous.
Sedative/hypnotics triazolam, oral midazolam ↑ triazolam ↑ midazolam Co-administration contraindicated due to potential for extreme sedation and respiratory depression [see Contraindications (4) ] . midazolam (administered parenterally) ↑ midazolam Co-administration of midazolam (parenteral) should be done in a setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. Dosage reduction for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Mechanism: Nirmatrelvir/ritonavir makes midazolam stay in your body much longer and at higher levels than normal. This can cause you to become dangerously sleepy or have trouble breathing.
Other Drug Interactions Caution is advised when midazolam is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole.
Mechanism: Ketoconazole blocks the specific liver enzyme that your body uses to break down midazolam. This can cause the midazolam to build up in your system and make its effects much stronger.
Other Drug Interactions Caution is advised when midazolam is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. The effects of diltiazem (60 mg tid) and verapamil (80 mg tid) on the pharmacokinetics and pharmacodynamics of midazolam were investigated in a three-way crossover study (n=9). The half-life of midazolam increased from 5 to 7 hours when midazolam was taken in conjunction with verapamil or diltiazem.
Mechanism: Verapamil interferes with the liver enzyme responsible for clearing midazolam from your body. This causes the midazolam to stay in your blood for a longer period of time.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can midazolam be given to children?
Can midazolam be mixed with other medicines?
What should I tell my doctor before receiving midazolam?
Can midazolam cause withdrawal symptoms?
Will I remember the procedure after taking midazolam?
Can I drive after taking midazolam?
What are the signs of an allergic reaction to midazolam?
Can midazolam affect my blood pressure?
Is midazolam addictive?
What should I do if I feel agitated or confused after receiving midazolam?
What are the common side effects of midazolam?
Does midazolam interact with other medications?
What drug class is midazolam?
What pregnancy or breastfeeding source fields are listed for midazolam?
Is midazolam currently in shortage?
Related Medications in Benzodiazepine
Other drugs grouped near midazolam - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with midazolam →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with midazolam →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with midazolam →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with midazolam →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with midazolam →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for midazolam: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 24,014.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 19.04%.
- tramadol Δ 0.05 pts · 36,174 reports · Opioid Analgesic 18.99%death share
- diphenhydramine Δ 0.28 pts · 60,533 reports · First-Generation Antihistamine 18.77%death share
- chlorpromazine Δ 0.32 pts · 6,862 reports · Typical Antipsychotic (Phenothiazine) 18.73%death share
- ranibizumab Δ 0.33 pts · 26,174 reports · Anti-VEGF (Ophthalmic Injection) 19.38%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for midazolam
The FDA label for midazolam (sold under brand names such as Versed) classifies it as a prescription-only medication in the Benzodiazepine class. Midazolam is used to sedate you before a surgery or procedure to help you relax and feel less anxious. Official labeling lists 3 commonly reported side effects, including Decreased breathing rate, Tenderness at the injection site, Pain during injection.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 24,014 voluntary reports. The database also lists 39 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.61.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: December 5, 2023
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages