Two medicines, side by side
Divalproex vs lithium
Divalproex and lithium are both labeled for bipolar disorder. Drugs@FDA records approvals of divalproex since 1983 and of lithium since 1970. Pharmacies paid $0.194 per divalproex sod ER 500 mg tablet and $0.104 per lithium carbonate 300 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Divalproex, “Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract.”; Lithium, “The mechanism of action of lithium as a mood stabilizing agent is unknown.”
Check it at the source: the divalproex FDA label on DailyMed (effective March 31, 2026); the lithium FDA label on DailyMed (effective December 23, 2025).
Highlights of the divalproex record
Divalproex (Depakote) · label of March 31, 2026
LIFE THREATENING ADVERSE REACTIONS Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur.
Used for
From the label: indicationsDepakote is an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder ( 1.1 ) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2 ) Prophylaxis of migraine headaches ( 1.3 ) 1.1 Mania Depakote (divalproex sodium) is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. […]
On the market
- Earliest approval on file
- March 10, 1983
- Generic labelers
- 44 labelers
- Pharmacy cost
- $0.194 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 16
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 (Divalproex label of March 31, 2026, Lithium label of December 23, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do divalproex and lithium differ on the record?
How each works, in its label's words: Divalproex, “Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract.”; Lithium, “The mechanism of action of lithium as a mood stabilizing agent is unknown.”
Both are in FDA's class mood stabilizers.
Half-life, in each label's words: Divalproex, “Mean terminal half-life for valproate monotherapy ranged from 9 to 16 hours following oral dosing regimens of 250 to …”; Lithium, “The elimination half-life of lithium is approximately 18 to 36 hours.”
Both labels carry a boxed warning; the records quote them.
Generics: divalproex since 2008; lithium since 1986 (Drugs@FDA).
| Divalproex | Lithium | |
|---|---|---|
| Labeled for | Bipolar disorder, Migraine, Seizures and epilepsy | Bipolar disorder |
| Pharmacologic class | Anti-epileptic Agent, Mood Stabilizer | Mood Stabilizer |
| How it works (label) | Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. | The mechanism of action of lithium as a mood stabilizing agent is unknown. |
| Half-life (label) | Mean terminal half-life for valproate monotherapy ranged from 9 to 16 hours following oral dosing regimens of 250 to 1,000 mg. | The elimination half-life of lithium is approximately 18 to 36 hours. |
| Earliest approval on file (Drugs@FDA) | March 10, 1983 | April 6, 1970 |
| First generic approved | July 29, 2008 | May 21, 1986 |
| Generic labelers (NDC) | 44 labelers | 24 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.194 per tablet (Divalproex sod ER 500 mg tablet) | $0.104 per capsule (Lithium carbonate 300 mg capsule) |
| 12-month price change | +3% | -6% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 16 | 4 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 46,267 | 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 divalproex
- every medicine labeled for the same conditions