Two medicines, side by side
Lithium vs risperidone
Lithium and risperidone are both labeled for bipolar disorder. Drugs@FDA records approvals of lithium since 1970 and of risperidone since 1993. Pharmacies paid $0.104 per lithium carbonate 300 mg capsule and $0.0368 per risperidone 0.25 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, lithium is a mood stabilizer and risperidone an atypical antipsychotic.
Check it at the source: the lithium FDA label on DailyMed (effective December 23, 2025); the risperidone FDA label on DailyMed (effective May 28, 2026).
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
Highlights of the risperidone record
Risperidone (Risperdal) · label of May 28, 2026
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. RISPERDAL is not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1) ] WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning.
Used for
From the label: indicationsRISPERDAL is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia RISPERDAL (risperidone) is indicated for the treatment of schizophrenia. […]
On the market
- Earliest approval on file
- December 29, 1993
- Generic labelers
- 37 labelers
- Pharmacy cost
- $0.0368 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 5
Source: FDA drug labels via openFDA (Lithium label of December 23, 2025, Risperidone label of May 28, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do lithium and risperidone differ on the record?
In FDA's classes, lithium is a mood stabilizer and risperidone an atypical antipsychotic.
How each works, in its label's words: Lithium, “The mechanism of action of lithium as a mood stabilizing agent is unknown.”; Risperidone, “The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2 ) receptor antagonism.”
Half-life, in each label's words: Lithium, “The elimination half-life of lithium is approximately 18 to 36 hours.”; Risperidone, “The apparent half-life of risperidone was 3 hours (CV=30%) in extensive metabolizers and 20 hours (CV=40%) in poor …”
Both labels carry a boxed warning; the records quote them.
Generics: lithium since 1986; risperidone since 2008 (Drugs@FDA).
| Lithium | Risperidone | |
|---|---|---|
| Labeled for | Bipolar disorder | Bipolar disorder, Schizophrenia |
| Pharmacologic class | Mood Stabilizer | Atypical Antipsychotic |
| How it works (label) | The mechanism of action of lithium as a mood stabilizing agent is unknown. | The mechanism of action of risperidone in schizophrenia is unclear. The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2 ) receptor antagonism. |
| Half-life (label) | The elimination half-life of lithium is approximately 18 to 36 hours. | The apparent half-life of risperidone was 3 hours (CV=30%) in extensive metabolizers and 20 hours (CV=40%) in poor metabolizers. |
| Earliest approval on file (Drugs@FDA) | April 6, 1970 | December 29, 1993 |
| First generic approved | May 21, 1986 | June 30, 2008 |
| Generic labelers (NDC) | 24 labelers | 37 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.104 per capsule (Lithium carbonate 300 mg capsule) | $0.0368 per tablet (Risperidone 0.25 mg tablet) |
| 12-month price change | -6% | -13% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 4 | 5 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 41,678 | 131,095 |
| 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)
Do their labels mention each other?
Risperidone label, drug interactions… needed Other Drugs Amitriptyline 50 mg twice daily 3 mg twice daily 1.2 1.1 Dose adjustment not needed Effect of Risperidone on Other Drugs Lithium Repeated oral doses of RISPERDAL (3 mg twice daily) did not affect the exposure (AUC) or peak plasma concentrations (C max ) of lithium (n=13). Dose adjustment for lithium is not recommended.
Risperidone label, drug interactionsRepeated doses of oral RISPERDAL (3 mg twice daily) did not affect the exposure (AUC) or peak plasma concentrations (C max ) of lithium (N=13).
Source: FDA drug labels via openFDA
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 lithium
- every medicine labeled for the same conditions