Prescription medicine
Clemastine Brand names: Clemsza; first approved as Tavist-1
Clemastine (Clemsza) is a prescription medicine with an FDA approval on record since 1977. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $3.18 per clemastine fum 2.68 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the clemastine FDA label on DailyMed (effective February 3, 2025, Genus Lifesciences); the NDA 17661 record on Drugs@FDA; every clemastine label on DailyMed.
Highlights of the record
FDA label of February 3, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageClemastine Fumarate Tablets USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation.
Forms and strengths
- 2.68 mg
- 0.67 mg/5ml
Syrup; tablet.
On the market
- Earliest approval on file
- February 25, 1977 Tavist-1, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first January 31, 1992; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $3.18 per tablet Clemastine fum 2.68 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,357 through July 30, 2026
What is clemastine used for?
From the label: indications and usageClemastine Fumarate Tablets USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only.
Conditions named in the indications of clemastine's FDA labels, with every medicine labeled for each:
From other clemastine labelsAllergies: INDICATIONS AND USAGE Clemastine Fumarate Tablets USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation.
Source: FDA drug label (Clemastine Fumarate), Genus Lifesciences, effective February 3, 2025 (SPL set cf8a3449-8bb3-4d5c-8d0d-557590e49ee5), via openFDA; the full label on DailyMed
Is there a generic for clemastine (Clemsza)?
The FDA approved the first generic clemastine on January 31, 1992. 11 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists clemastine from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1977 earliest approval on file
- 1992 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for clemastine (Clemsza)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $3.18 per Clemastine fum 2.68 mg tablet, up 534% from $0.501 on September 24, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Clemastine fum 2.68 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clemastine 0.5 mg/5 mL syrup | Generic | $5.49 per mL | n/a | -1% |
| Clemastine fum 2.68 mg tablet | Generic | $3.18 per tablet | $95.33 | +534% |
| Clemsza 2.68 mg tablet | Generic | $3.18 per tablet | $95.33 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for clemastine?
The FDA Adverse Event Reporting System holds 1,357 reports that list clemastine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 174 are coded as a death and 763 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as clemastine?
10 other medicines are given the same way (oral) and in the same FDA class as clemastine or labeled mainly for the same use (allergies), the same class first. Allergies lists all 36 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cetirizine | Allergies | 164 labelers | $0.0613 per tablet 10 mg tablet | No current entry |
| Fexofenadine | Allergies | 110 labelers | $0.230 per tablet 180 mg tablet | No current entry |
| Levocetirizine | Allergies | 53 labelers | $0.0511 per tablet 5 mg tablet | No current entry |
| Chlorpheniramine | Allergies | 2 labelers | $0.0177 per tablet 4 mg tablet | No current entry |
| Desloratadine | Allergies | 9 labelers | $0.258 per tablet 5 mg tablet | No current entry |
| Carbinoxamine | Allergies | 7 labelers | $0.398 per tablet 4 mg tablet | No current entry |
| Chlorpheniramine and ibuprofen and phenylephrine | Allergies | none listed | n/a | No current entry |
| Chlorpheniramine and ibuprofen and pseudoephedrine | Allergies | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Clemastine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other