Two medicines, side by side
Carbamazepine vs lithium
Carbamazepine and lithium are both labeled for bipolar disorder. Drugs@FDA records approvals of carbamazepine since 1968 and of lithium since 1970. Pharmacies paid $0.119 per carbamazepine 200 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: Carbamazepine, “It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation.”; Lithium, “The mechanism of action of lithium as a mood stabilizing agent is unknown.”
Check it at the source: the carbamazepine FDA label on DailyMed (effective August 20, 2026); the lithium FDA label on DailyMed (effective December 23, 2025).
Highlights of the carbamazepine record
Carbamazepine (Tegretol) · label of August 20, 2026
SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH TEGRETOL. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER.
Used for
From the label: indicationsEpilepsy Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. […]
On the market
- Earliest approval on file
- March 11, 1968
- Generic labelers
- 42 labelers
- Pharmacy cost
- $0.119 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 11
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 (Carbamazepine label of August 20, 2026, Lithium label of December 23, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do carbamazepine and lithium differ on the record?
How each works, in its label's words: Carbamazepine, “It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation.”; 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: Carbamazepine, “Initial half-life values range from 25 to 65 hours, decreasing to 12 to 17 hours on repeated doses.”; Lithium, “The elimination half-life of lithium is approximately 18 to 36 hours.”
Both labels carry a boxed warning; the records quote them.
Generics: carbamazepine since 1986; lithium since 1986 (Drugs@FDA).
| Carbamazepine | Lithium | |
|---|---|---|
| Labeled for | Bipolar disorder, Seizures and epilepsy | Bipolar disorder |
| Pharmacologic class | Mood Stabilizer | Mood Stabilizer |
| How it works (label) | Mechanism of Action Tegretol has demonstrated anticonvulsant properties in rats and mice with electrically and chemically induced seizures. It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation. | The mechanism of action of lithium as a mood stabilizing agent is unknown. |
| Half-life (label) | Initial half-life values range from 25 to 65 hours, decreasing to 12 to 17 hours on repeated doses. | The elimination half-life of lithium is approximately 18 to 36 hours. |
| Earliest approval on file (Drugs@FDA) | March 11, 1968 | April 6, 1970 |
| First generic approved | August 14, 1986 | May 21, 1986 |
| Generic labelers (NDC) | 42 labelers | 24 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.119 per tablet (Carbamazepine 200 mg tablet) | $0.104 per capsule (Lithium carbonate 300 mg capsule) |
| 12-month price change | +0.6% | -6% |
| Boxed warning | Yes | Yes |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 11 | 4 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 66,615 | 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)
Do their labels mention each other?
Carbamazepine label, drug interactionsConcomitant administration of carbamazepine and lithium may increase the risk of neurotoxic side effects.
Carbamazepine label, drug interactionsLithium Concomitant administration of carbamazepine and lithium may increase the risk of neurotoxic side effects.
Lithium label, drug interactionsClinical Impact: Concomitant use can lower serum lithium concentrations by increasing urinary lithium excretion. … response [see Dosage and Administration ( 2.3 )]. Methyldopa, Phenytoin and Carbamazepine
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 carbamazepine
- every medicine labeled for the same conditions