Prescription medicine
Pilocarpine Brand names: Salagen, Qlosi; first approved as Ocusert Pilo-20
Pilocarpine (Salagen) is a prescription medicine with an FDA approval on record since 1974. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.338 per pilocarpine HCl 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the pilocarpine FDA label on DailyMed (effective December 5, 2024, Advanz Pharma (US) Corp.); the NDA 17431 record on Drugs@FDA; every pilocarpine label on DailyMed.
Highlights of the record
FDA label of December 5, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSALAGEN ® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck;
Forms and strengths
- 5 mg
- 7.5 mg
- 4 mg/ml
- 10 mg/ml
- 12.5 mg/ml
- 20 mg/ml
- 40 mg/ml
Film-coated tablet; solution/ drops; solution.
On the market
- Earliest approval on file
- July 29, 1974 Ocusert Pilo-20, Epic Pharma Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first November 16, 2004; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 7 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- April 24, 2039 Vuity solution/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.338 per tablet Pilocarpine HCl 5 mg tablet
- Shortage (FDA)
- None current 5 past records
- Recalls by its makers (FDA)
- 4 since 2014 0 Class I among all firms' recalls; latest April 26, 2023; 3 more by firms not listed as its makers
- FAERS reports
- 2,463 through July 30, 2026
What is pilocarpine used for?
From the label: indications and usageSALAGEN ® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
Conditions named in the indications of pilocarpine's FDA labels, with every medicine labeled for each:
From other pilocarpine labelsGlaucoma: The reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. (1.1) The management of acute angle-closure glaucoma. …
FDA pharmacologic class: Cholinergic Receptor Agonist.
Source: FDA drug label (Salagen), Advanz Pharma (US) Corp., effective December 5, 2024 (SPL set 62eda83d-d043-4c7e-8fcf-75d05efbf35b), via openFDA; the full label on DailyMed
Is there a generic for pilocarpine (Salagen)?
The FDA approved the first generic pilocarpine on November 16, 2004. 10 generic applications are approved; 9 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 pilocarpine from 7 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Salagen tablets; a patent listed only for Vuity solution/drops runs to April 24, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1974 earliest approval on file
- 2004 first generic approved
- 2039 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pilocarpine (Salagen)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.338 per Pilocarpine HCl 5 mg tablet, down 7% from $0.364 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.
- Pilocarpine HCl 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pilocarpine 1% eye drops | Generic | $3.45 per mL | n/a | +2% |
| Pilocarpine 2% eye drops | Generic | $2.81 per mL | n/a | -22% |
| Pilocarpine 4% eye drops | Generic | $3.38 per mL | n/a | -2% |
| Pilocarpine HCl 1.25% eye drop | Generic | $22.07 per mL | n/a | n/a |
| Pilocarpine HCl 5 mg tablet | Generic | $0.338 per tablet | $10.15 | -7% |
| Pilocarpine HCl 7.5 mg tablet | Generic | $0.354 per tablet | $10.62 | -19% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is pilocarpine in shortage?
No pilocarpine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 5 records are all marked to be discontinued, the latest updated March 24, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Vuity, Ophthalmic Solution, 12.5 mg/1 mL (NDC 0074-7098-01) | AbbVie Inc. | To Be Discontinued | March 24, 2026 |
| Vuity, Ophthalmic Solution, 12.5 mg/1 mL (NDC 0074-7098-03) | AbbVie Inc. | To Be Discontinued | March 24, 2026 |
| Vuity, Ophthalmic Solution, 12.5 mg/1 mL (NDC 0074-7098-04) | AbbVie Inc. | To Be Discontinued | March 24, 2026 |
| Vuity, Ophthalmic Solution, 12.5 mg/1 mL (NDC 0074-7098-05) | AbbVie Inc. | To Be Discontinued | March 24, 2026 |
| Vuity, Ophthalmic Solution, 12.5 mg/1 mL (NDC 0074-7098-06) | AbbVie Inc. | To Be Discontinued | March 24, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has pilocarpine been recalled?
The FDA's Enforcement Report lists 7 recalls naming pilocarpine since 2014: 0 Class I (the most serious), 6 Class II, 1 Class III; 3 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of pilocarpine and that hold 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 |
|---|---|---|---|
| April 26, 2023 | Class II | Akorn, Inc. | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office not a listed maker | cGMP deviations: Temperature abuse |
| March 22, 2017 | Class III | Novartis Pharmaceuticals Corp. | Failed Impurities/Degradation Specifications. |
| September 12, 2015 | Class II | US Compounding Inc not a listed maker | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on … |
| August 27, 2014 | Class II | Martin Avenue Pharmacy, Inc. not a listed maker | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pilocarpine label say about other medicines?
The pilocarpine label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name pilocarpine. 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 |
|---|---|---|
| Atropine | drug interactions | These effects should be considered when anticholinergic properties may be contributing to the therapeutic effect of concomitant medication (e.g., atropine, inhaled ipratropium). |
| Hydroxychloroquine | drug interactions | While no formal drug interaction studies have been performed, the following concomitant drugs were used in at least 10% of patients in either or both Sjogren's efficacy studies: acetylsalicylic acid, artificial tears, calcium, conjugated estrogens, hydroxychloroquine sulfate, ibuprofen, levothyroxine sodium … |
| Ibuprofen | drug interactions | … studies: acetylsalicylic acid, artificial tears, calcium, conjugated estrogens, hydroxychloroquine sulfate, ibuprofen, levothyroxine sodium, medroxyprogesterone acetate, methotrexate, multivitamins, naproxen, omeprazole, paracetamol, and prednisone. |
| Ipratropium | drug interactions | These effects should be considered when anticholinergic properties may be contributing to the therapeutic effect of concomitant medication (e.g., atropine, inhaled ipratropium). |
| Levothyroxine | drug interactions | … acetylsalicylic acid, artificial tears, calcium, conjugated estrogens, hydroxychloroquine sulfate, ibuprofen, levothyroxine sodium, medroxyprogesterone acetate, methotrexate, multivitamins, naproxen, omeprazole, paracetamol, and prednisone. |
| Medroxyprogesterone | drug interactions | … artificial tears, calcium, conjugated estrogens, hydroxychloroquine sulfate, ibuprofen, levothyroxine sodium, medroxyprogesterone acetate, methotrexate, multivitamins, naproxen, omeprazole, paracetamol, and prednisone. |
| Methotrexate | drug interactions | … conjugated estrogens, hydroxychloroquine sulfate, ibuprofen, levothyroxine sodium, medroxyprogesterone acetate, methotrexate, multivitamins, naproxen, omeprazole, paracetamol, and prednisone. |
| Naproxen | drug interactions | … hydroxychloroquine sulfate, ibuprofen, levothyroxine sodium, medroxyprogesterone acetate, methotrexate, multivitamins, naproxen, omeprazole, paracetamol, and prednisone. |
| Omeprazole | drug interactions | … sulfate, ibuprofen, levothyroxine sodium, medroxyprogesterone acetate, methotrexate, multivitamins, naproxen, omeprazole, paracetamol, and prednisone. |
| Prednisone | drug interactions | … levothyroxine sodium, medroxyprogesterone acetate, methotrexate, multivitamins, naproxen, omeprazole, paracetamol, and prednisone. |
Other labels that name pilocarpine
Source: FDA drug label (Salagen), Advanz Pharma (US) Corp., effective December 5, 2024 (SPL set 62eda83d-d043-4c7e-8fcf-75d05efbf35b), via openFDA; the full label on DailyMed
What do FAERS reports show for pilocarpine?
The FDA Adverse Event Reporting System holds 2,463 reports that list pilocarpine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 98 are coded as a death and 677 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
How does pilocarpine compare with medicines for the same use?
1 side-by-side page set pilocarpine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other cholinergic receptor agonists
- the pharmacologic class, with prices and generics
- Pilocarpine side effects
- the label's list beside FAERS reports
- Pilocarpine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other