Prescription medication · Atypical Antipsychotic
quetiapine
Also sold as Seroquel. Quetiapine is used to treat schizophrenia in adults and teens (13-17 years old).
- 185,533
- FDA reportsHeavily reported
- 9
- InteractionsFew interactions
- 84% less
- Generic vs brandHuge savings
- $6.41
- Brand price (NADAC)
What the data shows
quetiapine (Seroquel) is a prescription Atypical Antipsychotic, more reported than roughly 9 in 10 tracked drugs (185,533 FDA reports), whose generic runs roughly half the brand price or less (84% less).
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.
quetiapine (Seroquel) is a prescription Atypical Antipsychotic. Quetiapine is used to treat schizophrenia in adults and teens (13-17 years old).
Quetiapine is a medicine that belongs to a class of drugs called atypical antipsychotics. It is used to treat mental disorders like schizophrenia and bipolar disorder.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$6.41/unit
Generic Price
$1.04/unit
Generic Savings
84%
Generic Available
Yes (23 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Quetiapine is used to treat schizophrenia in adults and teens (13-17 years old).
Common side effects
Feeling sleepy, Dry mouth, Dizziness
Key warnings
Quetiapine may increase the risk of death in elderly patients who have psychosis related to dementia.
The sections below are summarized in plain English from quetiapine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Quetiapine works by changing the levels of certain natural substances in the brain. These substances are called neurotransmitters. By affecting these neurotransmitters, quetiapine can help reduce symptoms of mental disorders.
How to Take It
Take quetiapine tablets with or without food. Your doctor will tell you how much to take each day. The dose depends on your condition and age. Follow your doctor's instructions carefully and do not change your dose without talking to them.
This is a plain-language summary of quetiapine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
If you take quetiapine during the last 3 months of pregnancy, your baby may have withdrawal symptoms or other problems after birth. There is a pregnancy registry to track outcomes in women who take quetiapine during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant.
This is a plain-language summary of quetiapine'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 quetiapine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store quetiapine tablets at room temperature, away from heat and moisture.
Side Effects (from patient reports)
Based on 185,533 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for quetiapine, by number of reports
- Harmful effects from different substances
Harmful effects from different substances
9,721 reports
- Trouble sleeping
Trouble sleeping
9,103 reports
- Feeling tired
Feeling tired
8,861 reports
- Diabetes
Diabetes
8,343 reports
- Weight gain
Weight gain
8,153 reports
- The medicine is interacting with another medicine
The medicine is interacting with another medicine
8,115 reports
- Sleepiness
Sleepiness
8,002 reports
- Feeling sick to your stomach
Feeling sick to your stomach
7,977 reports
- Feeling sad and hopeless
Feeling sad and hopeless
7,805 reports
- Feeling worried and nervous
Feeling worried and nervous
7,653 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 quetiapine 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 quetiapine sits
quetiapine has more FDA adverse-event reports than 94% 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 quetiapine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 185,533 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
185,533
Reports Mentioning Death
26,984
14.5% of reports — not proof of cause
Hospitalization Reports
67,436
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 3 | TOXICITY TO VARIOUS AGENTS | 9,720 |
| 4 | INSOMNIA | 9,103 |
| 5 | FATIGUE | 8,863 |
| 6 | DIABETES MELLITUS | 8,342 |
| 7 | WEIGHT INCREASED | 8,154 |
| 8 | DRUG INTERACTION | 8,115 |
| 9 | SOMNOLENCE | 8,000 |
| 10 | NAUSEA | 7,978 |
| 11 | DEPRESSION | 7,805 |
| 12 | ANXIETY | 7,655 |
| 13 | COMPLETED SUICIDE | 7,101 |
| 14 | DIZZINESS | 6,855 |
| 15 | PAIN | 6,814 |
| 16 | HEADACHE | 6,751 |
| 17 | VOMITING | 6,584 |
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
Quetiapine may increase the risk of death in elderly patients who have psychosis related to dementia. Quetiapine can also increase the risk of suicidal thoughts and behavior in children, teens, and young adults. Watch for worsening symptoms or suicidal thoughts, and tell your doctor right away.
Known Drug Interactions
Colchicine (in patients with normal renal and hepatic function) Use With Caution Antipsychotics: Pimozide Contraindicated Pimozide: [See Contraindications ( 4.2 )] Quetiapine Lurasidone Quetiapine: Quetiapine is a substrate for CYP3A4, which is inhibited by clarithromycin. Co‑administration with clarithromycin could result in increased quetiapine exposure and possible quetiapine related toxicities. Refer to quetiapine prescribing information for recommendations on dose reduction if co‑administered with CYP3A4 inhibitors such as clarithromycin.
Mechanism: Clarithromycin stops your body from breaking down quetiapine, which can cause the drug to build up to toxic levels.
What to do: Your doctor may need to lower your quetiapine dose while you are taking this antibiotic.
quetiapine ↑ quetiapine Initiation of darunavir with ritonavir in patients taking quetiapine: Consider alternative antiretroviral therapy to avoid increases in quetiapine exposures. If co-administration is necessary, reduce the quetiapine dose to 1/6 of the current dose and monitor for quetiapine-associated adverse reactions. Refer to the quetiapine prescribing information for recommendations on adverse reaction monitoring.
Mechanism: Darunavir slows down how fast your body processes quetiapine, which can lead to dangerously high levels of the drug in your system.
What to do: If you must take both, your doctor should reduce your quetiapine dose to one-sixth of the normal amount and watch you closely for side effects.
7 DRUG INTERACTIONS Concomitant use of strong CYP3A4 inhibitors: Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) ( 2.5 , 7.1 , 12.3 ) Concomitant use of strong CYP3A4 inducers: Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7-14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. Quetiapine exposure is increased by the prototype CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.) and decreased by the prototype CYP3A4...
Mechanism: Ketoconazole slows down the body's ability to break down quetiapine, which causes the level of quetiapine in your blood to rise significantly. This increase can lead to a higher risk of side effects.
What to do: Your doctor should reduce your quetiapine dose to one-sixth of the original amount when taking it with ketoconazole.
Quetiapine exposure is increased by the prototype CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.) and decreased by the prototype CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St.
Mechanism: Carbamazepine speeds up the process your body uses to get rid of quetiapine. This causes the amount of quetiapine in your system to drop, which may make the drug less effective.
What to do: Your doctor may need to increase your quetiapine dose up to five times the original amount to ensure it continues to work.
7 DRUG INTERACTIONS Concomitant use of strong CYP3A4 inhibitors: Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) ( 2.5 , 7.1 , 12.3 ) Concomitant use of strong CYP3A4 inducers: Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7-14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. Quetiapine exposure is increased by the prototype CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.) and decreased by the prototype CYP3A4...
Mechanism: Rifampin speeds up the process of your body breaking down quetiapine, which lowers the amount of medicine in your blood.
What to do: Your doctor may need to increase your quetiapine dose up to five times the normal amount if you take these together for more than a week.
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 quetiapine?
What should I do if I feel dizzy after taking quetiapine?
Will quetiapine make me gain weight?
Can I stop taking quetiapine suddenly?
Does quetiapine interact with other medications?
How often will I see my doctor while taking quetiapine?
Can children take quetiapine?
What if I have side effects?
Can I drive while taking quetiapine?
How long does it take for quetiapine to work?
What are the common side effects of quetiapine?
Does quetiapine interact with other medications?
What drug class is quetiapine?
Is there a generic version of quetiapine?
Is quetiapine safe during pregnancy?
Related Medications in Atypical Antipsychotic
Other drugs grouped near quetiapine - same-class peers and common alternatives.
acamprosate
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alprazolam
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amitriptyline
Elavil
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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.
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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 quetiapine
The FDA label for quetiapine (sold under brand names such as Seroquel) classifies it as a prescription-only medication in the Atypical Antipsychotic class. Quetiapine is used to treat schizophrenia in adults and teens (13-17 years old). Official labeling lists 15 commonly reported side effects, including Feeling sleepy, Dry mouth, Dizziness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 185,533 voluntary reports. The database also lists 9 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 $1.04 versus $6.41 for the brand - a 84% generic savings.
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: June 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