Prescription medicine
Desloratadine Brand names: Clarinex
Desloratadine (Clarinex) is a prescription medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $0.258 per desloratadine 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the desloratadine FDA label on DailyMed (effective May 17, 2025, Organon LLC); the NDA 21165 record on Drugs@FDA; every desloratadine label on DailyMed.
Highlights of the record
FDA label of May 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCLARINEX is a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older.
Forms and strengths
- 2.5 mg
- 5 mg
- 0.5 mg/ml
Film-coated tablet; tablet; orally disintegrating tablet; solution.
On the market
- Earliest approval on file
- December 21, 2001 Clarinex, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first February 19, 2010; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.258 per tablet Desloratadine 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest December 20, 2023; 1 more by firms not listed as its makers
- FAERS reports
- 10,661 through July 30, 2026
What is desloratadine used for?
From the label: indications and usageCLARINEX is a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. ( 1.1 ) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older. ( 1.2 ) Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 6 months of age and older. […]
Conditions named in the indications of desloratadine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Histamine-1 Receptor Antagonist.
Source: FDA drug label (Clarinex), Organon LLC, effective May 17, 2025 (SPL set c671342e-69a2-4ca5-abc2-8166ed4240d4), via openFDA; the full label on DailyMed
Is there a generic for desloratadine (Clarinex)?
The FDA approved the first generic desloratadine on February 19, 2010. 11 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists desloratadine from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2001 earliest approval on file
- 2010 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for desloratadine (Clarinex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.258 per Desloratadine 5 mg tablet, down 13% from $0.297 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Desloratadine 5 mg tablet (generic)
- Clarinex 5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Desloratadine 5 mg ODT | Generic | $4.78 per unit | n/a | +26% |
| Desloratadine 5 mg tablet | Generic | $0.258 per tablet | $7.73 | -13% |
| Clarinex 5 mg tablet | Brand | $8.85 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $265.43 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has desloratadine been recalled?
The FDA's Enforcement Report lists 2 recalls naming desloratadine since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of desloratadine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 20, 2023 | Class II | Lupin Pharmaceuticals Inc. | CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: DESLORATADINE, Tablet, 5 mg may have potentially been mislabeled as the following drug: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the desloratadine label say about other medicines?
The desloratadine label names 6 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Azithromycin | drug interactions | DRUG INTERACTIONS 7.1 Inhibitors of Cytochrome P450 3A4 In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety … |
| Cimetidine | drug interactions | In controlled clinical studies co-administration of desloratadine with cimetidine, a histamine H2-receptor antagonist, resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. … |
| Erythromycin | drug interactions | DRUG INTERACTIONS 7.1 Inhibitors of Cytochrome P450 3A4 In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety … |
| Fluoxetine | drug interactions | In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. … |
| Ketoconazole | drug interactions | DRUG INTERACTIONS 7.1 Inhibitors of Cytochrome P450 3A4 In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety … |
| Loratadine | contraindications | CONTRAINDICATIONS CLARINEX Tablets, RediTabs, and Oral Solution are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [see Warnings and Precautions (5.1) and Adverse Reactions (6.2) ]. |
Source: FDA drug label (Clarinex), Organon LLC, effective May 17, 2025 (SPL set c671342e-69a2-4ca5-abc2-8166ed4240d4), via openFDA; the full label on DailyMed
What do FAERS reports show for desloratadine?
The FDA Adverse Event Reporting System holds 10,661 reports that list desloratadine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 591 are coded as a death and 4,050 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 desloratadine?
10 other medicines are given the same way (oral) and in the same FDA class as desloratadine 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 |
|---|---|---|---|---|
| Diphenhydramine | Allergies | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| 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 |
| 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 |
Every medicine labeled for the same conditions as desloratadine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does desloratadine compare with medicines for the same use?
6 side-by-side pages set desloratadine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to desloratadine
- 10 medicines for the same use
- Other antihistamines
- the pharmacologic class, with prices and generics
- Desloratadine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other