Quetiapine Fumarate
50 mg · Tablet
- Prescription only
- Atypical Antipsychotic
- Active substance
- Quetiapine Fumarate
- Made by
- Hikma Pharmaceuticals USA Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Quetiapine fumarate). It describes the substance, not this exact product.
The mechanism of action of quetiapine in the listed indications is unclear.
However, the efficacy of quetiapine in these indications could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5HT 2 ) antagonism.
Quetiapine is unlikely to interfere with the metabolism of drugs metabolized by cytochrome P450 enzymes.
The bioavailability of quetiapine is marginally affected by administration with food, with C max and AUC values increased by 25% and 15%, respectively.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-16
Safety of the active substance
From the US prescribing label for the same active substance (Quetiapine fumarate). It describes the substance, not this exact product.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning.
- 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.
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.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
Details
| Made by | Hikma Pharmaceuticals USA Inc. |
|---|---|
| Active substance | Quetiapine Fumarate |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Strength | 50 mg |
| Form | Tablet |
| Route | Oral |
| Packs | 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK · 100 TABLET in 1 BOTTLE |
| NDC | 0054-0229 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
195 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet, Film Coated94 products
150 mg2
150 mg · 2 companies
- Tablet82 products
50 mg14
50 mg · 14 companies
- A-S Medication Solutions
- Advanced Rx Pharmacy of Tennessee, LLC
- American Health Packaging
- AvPAK
- BluePoint Laboratories
- Bryant Ranch Prepack
- Golden State Medical Supply, Inc.
- Hikma Pharmaceuticals USA Inc. · this page
- Tablet, Extended Release14 products
50 mg2
50 mg · 2 companies
150 mg3
150 mg · 3 companies
200 mg3
200 mg · 3 companies
300 mg3
300 mg · 3 companies
400 mg3
400 mg · 3 companies
- Tablet, Film Coated, Extended Release5 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.