Two medicines, side by side
Quetiapine vs lithium
Quetiapine and lithium are both labeled for bipolar disorder. Drugs@FDA records approvals of quetiapine since 1997 and of lithium since 1970. Pharmacies paid $0.127 per quetiapine fumarate 300 mg tablet and $0.104 per lithium carbonate 300 mg capsule (NADAC, October 7, 2026). In FDA's classes, quetiapine is an atypical antipsychotic and lithium a mood stabilizer.
Check it at the source: the quetiapine FDA label on DailyMed (effective April 10, 2026); the lithium FDA label on DailyMed (effective December 23, 2025).
Highlights of the quetiapine record
Quetiapine (Seroquel) · label of April 10, 2026
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1) ]. SEROQUEL is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ].
Used for
From the label: indicationsSEROQUEL is an atypical antipsychotic indicated for the treatment of: • Schizophrenia ( 1.1 ) • Bipolar I disorder manic episodes (1.2) • Bipolar disorder, depressive episodes (1.2) 1.1 Schizophrenia SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). […]
On the market
- Earliest approval on file
- September 26, 1997
- Generic labelers
- 48 labelers
- Pharmacy cost
- $0.127 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 10
Highlights of the lithium record
Lithium (Lithobid) · label of December 23, 2025
LITHIUM TOXICITY Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating treatment [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.1 )]. WARNING: LITHIUM TOXICITY See full prescribing information for complete boxed warning.
Used for
From the label: indicationsLithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14 )] • Maintenance treatment in patients 7 years and older [see Clinical Studies (14)] Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older ( 1 ) • Maintenance treatment in patients 7 years and older […]
On the market
- Earliest approval on file
- April 6, 1970
- Generic labelers
- 24 labelers
- Pharmacy cost
- $0.104 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 4
Source: FDA drug labels via openFDA (Quetiapine label of April 10, 2026, Lithium label of December 23, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do quetiapine and lithium differ on the record?
In FDA's classes, quetiapine is an atypical antipsychotic and lithium a mood stabilizer.
How each works, in its label's words: Quetiapine, “The mechanism of action of quetiapine in the listed indications is unclear.”; Lithium, “The mechanism of action of lithium as a mood stabilizing agent is unknown.”
Half-life, in each label's words: Quetiapine, “Elimination of quetiapine is mainly via hepatic metabolism with a mean terminal half-life of about 6 hours within the …”; Lithium, “The elimination half-life of lithium is approximately 18 to 36 hours.”
Both labels carry a boxed warning; the records quote them.
Generics: quetiapine since 2012; lithium since 1986 (Drugs@FDA).
| Quetiapine | Lithium | |
|---|---|---|
| Labeled for | Schizophrenia, Bipolar disorder, Depression | Bipolar disorder |
| Pharmacologic class | Atypical Antipsychotic | Mood Stabilizer |
| How it works (label) | 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. | The mechanism of action of lithium as a mood stabilizing agent is unknown. |
| Half-life (label) | Elimination of quetiapine is mainly via hepatic metabolism with a mean terminal half-life of about 6 hours within the proposed clinical dose range. | The elimination half-life of lithium is approximately 18 to 36 hours. |
| Earliest approval on file (Drugs@FDA) | September 26, 1997 | April 6, 1970 |
| First generic approved | March 27, 2012 | May 21, 1986 |
| Generic labelers (NDC) | 48 labelers | 24 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.127 per tablet (Quetiapine fumarate 300 mg tablet) | $0.104 per capsule (Lithium carbonate 300 mg capsule) |
| 12-month price change | -9% | -6% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 10 | 4 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 191,480 | 41,678 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What do the labels say about using others of their kind?
Lithium label, warnings and precautionsIf concomitant use of lithium with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.
Source: FDA drug labels via openFDA
What next?
- Alternatives to quetiapine
- every medicine labeled for the same conditions