Quetiapine — uses, dosing, side effects & the brands that sell it · pharmaranks
Quetiapine: uses, dosing, side effects & brands
Quetiapine is an atypical antipsychotic sold in the U.S. under 3 brand and generic names, for autistic disorder, bipolar disorder and major depressive disorder. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Atypical Antipsychotic
Treats
Autistic Disorder, Bipolar Disorder and Major Depressive Disorder
Available as
Tablet · Tablet, extended release
Sold as
3 products — Quetiapine Fumarate, Seroquel and Seroquel XR
From the FDA label for Quetiapine Fumarate (application ANDA202939). Other quetiapine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Quetiapine tablets can be taken with or without food ( 2.1 ). Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia-Adults ( 2.2 ) 25 mg twice daily 150 to 750 mg/day 750 mg/day Schizophrenia-Adolescents (13 to 17 years) ( 2.2 ) 25 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex ( 2.2 ) 50 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy ( 2.2 ) 25 mg twice daily 400 to 600 mg/day 600 mg/day Bipolar Depression-Adults ( 2.2 ) 50 mg once daily at bedtime 300 mg/day 300 mg/day Geriatric Use : Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly ( 2.3 , 8.5 ) Hepatic Impairment : Lower starting dose (25 mg/day) and slower titration may be needed ( 2.4 , 8.7 , 12.3 ) 2.1 Important Administration Instructions Quetiapine tablets can be taken with or without food. 2.2 Recommended Dosing The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see CLINICAL STUDIES ( 14.1 and 14.2 )]. Table 1: Recommended Dosing for Quetiapine Tablets…
Quetiapine side effects
Most common adverse reactions (incidence ≥5% and twice placebo): Adults: somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, weight gain, lethargy, ALT increased, dyspepsia. ( 6.1 ) Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS ( 5.1 )] Suicidal thoughts and behaviors in adolescents and young adults [see WARNINGS AND PRECAUTIONS ( 5.2 )] Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS ( 5.3 )] Neuroleptic Malignant Syndrome (NMS) [see WARNINGS AND PRECAUTIONS ( 5.4 )] Metabolic changes (hyperglycemia, dyslipidemia, weight gain) [see WARNINGS AND PRECAUTIONS ( 5.5 )] Tardive dyskinesia [see WARNINGS AND PRECAUTIONS ( 5.6 )] Hypotension [see WARNINGS AND PRECAUTIONS ( 5.7 )] Falls [see WARNINGS AND PRECAUTIONS ( 5.8 )] Increases in blood pressure (children and adolescents) [see WARNINGS AND PRECAUTIONS (…
Every quetiapine product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Quetiapine pill imprints
Imprint
Strength
Colour
Shape
Maker
LU;Y17
100 mg
yellow
round
—
LU;Y18
200 mg
white
round
—
LU;Y19
300 mg
white
capsule
—
F;85
400 mg
yellow
capsule
—
LU;Y15
25 mg
pink
round
—
LU;Y16
50 mg
Frequently asked questions
What is quetiapine?
Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b , f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42 H 50 N 6 O 4 S 2 . C 4 H 4 O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (quetiapine) round, pink tablets, 50 mg (quetiapine) round, white tablets, 100 mg (quetiapine) round, yellow tablets, 200 mg (quetiapine) round, white tablets, 300 mg (quetiapine) capsule-shaped, white tablets and 400 mg (quetiapine) capsule-shaped, yellow tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide black; and the 100 mg and 400 mg tablets contain iron oxide yellow. Each 25 mg film-coated tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg…
What kind of drug is quetiapine?
The FDA classifies quetiapine as an atypical antipsychotic. Atypical antipsychotics block dopamine D2 receptors and serotonin 5-HT2A receptors in the brain, rebalancing these signaling chemicals to reduce hallucinations, delusions, and mood symptoms in conditions like schizophrenia and bipolar disorder. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take quetiapine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run quetiapine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is quetiapine sold under?
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take quetiapine
Known hypersensitivity to quetiapine or any components in the formulation. ( 4 ) Hypersensitivity to quetiapine or to any excipients in the quetiapine tablets formulation. Anaphylactic reactions have been reported in patients treated with quetiapine tablets.
Quetiapine drug interactions
Concomitant Use of Strong CYP3A4 Inhibitors: Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) ( 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 to 14 days) of potent CYP3A4 inducers (e.g. phenytoin, rifampin, St. John's wort) ( 2.6 , 7.1 , 12.3 ) Discontinuation of Strong CYP3A4 Inducers: Reduce quetiapine dose by 5 fold within 7 to 14 days of discontinuation of CYP3A4 inducers ( 2.6 , 7.1 , 12.3 ) 7.1 Effect of Other Drugs on Quetiapine The risks of using quetiapine in combination with other drugs have not been extensively evaluated in systematic studies. Given the primary CNS effects of quetiapine, caution should be used when it is taken in combination with other centrally acting drugs. Quetiapine potentiated the cognitive and motor effects of alcohol in a clinical trial in subjects with selected psychotic disorders, and alcoholic beverages should be limited while taking quetiapine. 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. John's wort etc.). Dose adjustment of quetiapine will be necessary if it is…
We track 3 quetiapine-containing products in the U.S.: Quetiapine Fumarate, Seroquel and Seroquel XR. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does quetiapine come in?
Across the brands we track, quetiapine is currently marketed as tablet and tablet, extended release, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic quetiapine?
Yes. Our catalog lists 1 generic quetiapine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.