Prescription medication · Benzodiazepine
diazepam
Also sold as Valium. Diazepam can help manage anxiety disorders or provide short-term relief from anxiety symptoms.
- 117,869
- FDA reportsOften reported
- 26
- InteractionsSeveral interactions
- $249.68
- Generic price (NADAC)
What the data shows
diazepam (Valium) is a prescription Benzodiazepine, more reported than most tracked drugs (117,869 FDA reports), with 26 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.
diazepam (Valium) is a prescription Benzodiazepine. Diazepam can help manage anxiety disorders or provide short-term relief from anxiety symptoms.
Diazepam (Valium) is a medicine that can help with anxiety, muscle spasms, and seizures. It belongs to a class of drugs called benzodiazepines, which work by slowing down the brain.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$249.68/unit
Generic Available
Yes (24 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Diazepam can help manage anxiety disorders or provide short-term relief from anxiety symptoms.
Common side effects
Drowsiness, Fatigue, Muscle weakness
Key warnings
Diazepam can be habit-forming and can cause serious side effects, including breathing problems, coma, and even death, especially when taken with opioid pain medicines or alcohol.
The sections below are summarized in plain English from diazepam's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Diazepam works by increasing the effects of a natural chemical in the brain called GABA. GABA helps to calm the brain and nerves. This can reduce anxiety, relax muscles, and prevent seizures.
How to Take It
Take diazepam exactly as your doctor tells you. Your dose will depend on your condition and how you respond to the medicine. It can be taken 2 to 4 times daily, depending on what you are treating. If you are elderly, your doctor may start you on a lower dose.
This is a plain-language summary of diazepam's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Diazepam may harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if diazepam passes into breast milk, so talk to your doctor before breastfeeding.
This is a plain-language summary of diazepam's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of diazepam's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store diazepam at room temperature, away from heat and moisture.
Side Effects (from patient reports)
Based on 117,869 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for diazepam, by number of reports
- Harm from certain substances
Harm from certain substances
9,167 reports
- Misuse of medicine
Misuse of medicine
7,019 reports
- Feeling sick to your stomach
Feeling sick to your stomach
6,144 reports
- Feeling tired
Feeling tired
5,714 reports
- Discomfort
Discomfort
5,202 reports
- Worry
Worry
4,983 reports
- Head pain
Head pain
4,967 reports
- Sleepiness
Sleepiness
4,897 reports
- Feeling unsteady
Feeling unsteady
4,483 reports
- Throwing up
Throwing up
4,386 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 diazepam 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 diazepam sits
diazepam has more FDA adverse-event reports than 88% 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 diazepam; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 117,869 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1996–2025.
Total Reports
117,869
Reports Mentioning Death
22,544
19.1% of reports — not proof of cause
Hospitalization Reports
40,899
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | TOXICITY TO VARIOUS AGENTS | 9,167 |
| 3 | DRUG ABUSE | 7,019 |
| 4 | NAUSEA | 6,149 |
| 5 | FATIGUE | 5,714 |
| 6 | PAIN | 5,202 |
| 7 | ANXIETY | 4,984 |
| 8 | HEADACHE | 4,963 |
| 9 | SOMNOLENCE | 4,899 |
| 11 | DIZZINESS | 4,484 |
| 12 | VOMITING | 4,387 |
| 13 | DYSPNOEA | 4,295 |
| 14 | FALL | 4,212 |
| 15 | OVERDOSE | 4,159 |
| 16 | DRUG INTERACTION | 4,139 |
| 17 | DIARRHOEA | 4,050 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Diazepam can be habit-forming and can cause serious side effects, including breathing problems, coma, and even death, especially when taken with opioid pain medicines or alcohol. You should not stop taking diazepam suddenly, as this can cause withdrawal symptoms. Talk to your doctor about how to slowly stop taking diazepam.
Known Drug Interactions
Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted.
Mechanism: These drugs are both sedatives that slow down your brain and body. Taking them together can make you dangerously sleepy or cause trouble breathing.
What to do: Do not take these two medicines at the same time unless your doctor tells you to.
Monoamine Oxidase Inhibitors (MAOIs): ( 2.9 , 2.10 , 4.1 , 5.2 ) Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway ( 7.7 ) Tricyclic Antidepressants (TCAs): Monitor TCA levels during coadministration with fluoxetine or when fluoxetine has been recently discontinued ( 5.2 , 7.7 ) CNS Acting Drugs: Caution should be used when taken in combination with other centrally acting drugs ( 7.2 ) Benzodiazepines: Diazepam – increased t½, alprazolam - further psychomotor performance decrement due to increased levels ( 7.7 ) Antipsychotics: Potential for elevation...
Mechanism: Fluoxetine makes diazepam stay in your body for a longer time than usual. This can lead to a buildup of the drug and cause more side effects.
What to do: Watch for increased drowsiness and be careful when driving or using machinery. Your doctor might need to adjust your treatment plan.
Examples diazepam, alprazolam, alcohol Drugs that Prolong QTc Interval Clinical Impact The concomitant use of other drugs which prolong the QTc interval with mirtazapine, increase the risk of QTc prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes).
Mechanism: Both medications can interfere with the heart's electrical system when used at the same time. This can lead to serious heart rhythm issues that may be life-threatening.
What to do: Your healthcare provider should check your heart's electrical activity with an EKG. Report any fainting or chest palpitations to your doctor immediately.
Highly protein-bound drugs include diazepam, diazoxide, and lidocaine. 7.3 Other Highly Protein-Bound Drugs Raloxifene hydrochloride should be used with caution with certain other highly protein-bound drugs such as diazepam, diazoxide, and lidocaine.
Mechanism: Both of these drugs like to attach to the same proteins in your blood. Because they compete for the same spots, one drug might get pushed off, leading to higher levels of active medicine in your system.
What to do: Use this combination with caution. Your doctor should monitor you closely for any increased side effects from either medication.
At present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole.
Mechanism: Omeprazole slows down the liver's ability to process diazepam. This can lead to higher levels of the drug in your body.
What to do: Your doctor may need to adjust your dose or watch you more closely for side effects like extra sleepiness.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I drink alcohol while taking diazepam?
Can I drive while taking diazepam?
What should I do if I think I am having a side effect?
Can I take diazepam with other medicines?
How long does diazepam take to work?
Can I become addicted to diazepam?
What are the symptoms of diazepam withdrawal?
Is it safe to take diazepam long-term?
What should I do if I accidentally take too much diazepam?
Can children take diazepam?
What are the common side effects of diazepam?
Does diazepam interact with other medications?
What drug class is diazepam?
Is diazepam safe during pregnancy?
Related Medications in Benzodiazepine
Other drugs grouped near diazepam - 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 diazepam →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with diazepam →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
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amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with diazepam →
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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for diazepam
The FDA label for diazepam (sold under brand names such as Valium) classifies it as a prescription-only medication in the Benzodiazepine class. Diazepam can help manage anxiety disorders or provide short-term relief from anxiety symptoms. Official labeling lists 4 commonly reported side effects, including Drowsiness, Fatigue, Muscle weakness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 117,869 voluntary reports. The database also lists 26 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $249.68.
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: October 27, 2025
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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