Salagen (Pilocarpine) - Oral

Warning:

What Is Salagen?

Salagen (pilocarpine) is a prescription drug used to alleviate the symptoms of xerostomia (dry mouth) due to saliva gland damage from radiation for head and neck cancer or dry mouth symptoms from Sjögren’s syndrome. It is used in adults 18 and older.

Pilocarpine is a cholinergic agonist, also called a cholinergic drug. It mimics the action of a chemical called acetylcholine.

Acetylcholine helps control muscle contraction, including muscles in your eye. It also helps regulate blood pressure and heart rate and stimulates secretions by certain glands, including salivary glands–essential in treating dry mouth.

Salagen is a prescription product, so you can’t purchase it over-the-counter (OTC). Instead, you’ll need a prescription for it from your healthcare provider and will buy it from your local pharmacy.

Salagen is available in the form or oral tablets to be taken by mouth.

Drug Facts

Generic Name: Pilocarpine

Brand Name: Salagen

Drug Availability: Prescription

Therapeutic Classification: Cholinergic agonist

Available Generically: Yes

Controlled Substance: N/A

Administration Route: Oral

Active Ingredient: Pilocarpine hydrochloride

Dosage Form: Tablet

What Is Salagen Used For?

Salagen is approved by the Food and Drug Administration (FDA) to treat the following:

  • Xerostomia, or dry mouth, is caused by radiation used to treat head and neck cancer. Radiation aims to stop the production of cancer cells but can harm healthy cells, such as those in your salivary glands that normally produce saliva, and prevent your mouth from drying out too much.
  • Xerostomia is caused by Sjögren's syndrome, an autoimmune condition that causes joint pain, dry eyes, and dry mouth, in addition to other effects on the body.

The key ingredient, pilocarpine, is also available as an ophthalmic solution, or eye drop, under the brand name Vuity. Pilocarpine is also approved to treat the following conditions but would be treated with Vuity, or generic pilocarpine eye drops rather than Salagen tablets:

  • Presbyopia, which is farsightedness or a loss of close-up vision
  • Raised intraocular pressure, or pressure inside the eye that is too high, is caused by angle-closure or open-angle glaucoma (a group of diseases that cause damage to the optic nerve)

How to Take Salagen

You can take Salagen tablets with or without food. The tablets usually have to be taken multiple times a day, often three or four. It can help to set phone reminders at regular intervals throughout your day, so you don’t accidentally miss doses.

Swallow the tablets whole. Do not crush, cut, or chew them.

Storage

Store Salagen at room temperature (between 59-86 degrees F), out of reach of children and pets. Avoid storing it in an area with a lot of heat and moisture, like the bathroom.

If you’re traveling by plane, you’ll want to keep Salagen in your carry-on luggage so that you aren’t separated from it in case your checked luggage goes missing.

If you’re traveling by car, take care not to leave your medicine in especially hot or cold temperatures for long periods of time, like overnight in the car.

Off-Label Uses

Pilocarpine is approved by the FDA to treat dry mouth of different causes as well as certain eye conditions. However, medications are sometimes used in non-approved conditions based on clinical experience and expert knowledge.

Pilocarpine has been shown to prevent mucositis following chemotherapy treatment. Mucositis is when the inside of your mouth feels sore and painful.

How Long Does Salagen Take to Work?

Dry mouth symptoms improve over time when you consistently take Salagen. However, it will most likely take patience and consistency in taking your prescribed pilocarpine dose for around 12 or more weeks before you see a decent improvement in your dry mouth symptoms.

What Are the Side Effects of Salagen?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

While most side effects studied in Salagen clinical trials went away within hours of stopping taking Salagen, common side effects associated with the drug include:

  • Hyperhidrosis (excessive sweating, due to the way pilocarpine stimulates your sweat glands in addition to salivary glands)
  • Headache
  • Nausea
  • Rhinitis (allergic-like symptoms such as runny or stuffy nose and sneezing)
  • Vasodilation (a widening of the blood vessels which may result in flushing, a reddening of the face and neck, and a warm or burning sensation)
  • Polyuria (frequent urination)

Severe Side Effects

Side effects that were found to be rarer in Salagen clinical trials yet potentially more serious include:

  • Heart effects such as hypotension (low blood pressure), hypertension (high blood pressure), bradycardia (slow heart rate), and tachycardia (fast heart rate), especially in people with prior heart conditions
  • Dyspepsia or indigestion, as pilocarpine may cause increased stomach acid secretion
  • Urinary tract infection (UTI; common infections that happen when bacteria, often from the skin or rectum, enter the urethra and infect the urinary tract)
  • Vaginitis (inflammation or infection of the vagina)

Call your healthcare provider right away if you feel like you are experiencing serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Report Side Effects

Salagen may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Salagen Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For dryness of eyes:
      • Adults—5 milligrams (mg) three or four times a day.
    • For dryness of mouth and throat:
      • Adults—5milligrams (mg) three or four times a day.
      • Children—Use and dose must be determined by your doctor.

Modifications

Users should be made aware of the following before beginning Salagen:

In pregnancy and breastfeeding: It's uncertain whether Salagen poses a risk in human pregnancy or if pilocarpine hydrochloride (the primary ingredient in Salagen) is excreted (expelled as waste) in human breast milk.

As such, Salagen should only be used during the pregnancy period or during nursing sessions only if the expected benefits outweigh the potential risks to the fetus or infant child. Speak with your healthcare provider about whether the benefits of Salagen are any risk it may pose to your pregnancy.

In pediatrics: The safety and effectiveness of Salagen in children under 18 have not been established. Therefore, this drug is recommended only for those older than 18 who meet all other benchmarks for prescription.

In older adults: Clinical trials for Salagen showed that the rate of pilocarpine absorption into the bloodstream was similar when comparing older adults to younger men.

However, in five healthy, older female volunteers, the mean Cmax (the highest concentration of a drug in the blood) and AUC (area under the curve; meaning the extent of exposure to a drug and its clearance rate from the body) was approximately twice that of older males and young normal male volunteers.

Be sure to discuss with your healthcare provider how your age may impact your ability to tolerate Salagen.

In hepatic impairment: If you have a hepatic impairment, or decreased liver function, you should start taking Salagen at a slightly lower dose and gradually increase your dose as tolerated. Clearing of the drug was seen to be slower in people with mild to moderate liver impairment.

Missed Dose

If you forget to take a dose of Salagen, just wait and take your next dose at the regularly scheduled time. Do not double up your dose or take a second tablet to make up for your missed dose.

Overdose: What Happens If I Take Too Much Salagen?

Cases of overdose have been reported with Salagen, and symptoms were mostly consistent with the known side effects of the drug, such as excessive sweating and gastrointestinal (GI) side effects.

Treatment for moderate overdosage would be generally keeping you well, such as giving intravenous (IV) hydration. If you are experiencing severe overdose symptoms, you may need treatment with atropine, the antidote to pilocarpine.

What Happens If I Overdose on Salagen?

If you think you or someone else may have overdosed on Salagen, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Salagen, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

This medicine may cause difficulty in reading or other vision problems, especially at night. It may also cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well. If these reactions are especially bothersome, check with your doctor.

This medicine may cause you to sweat more than is usual. If you do, it is important that you drink extra liquids to offset this sweating so you do not lose too much fluid and become dehydrated. Check with your doctor if you are not sure how much extra liquid to drink or if you cannot drink as much liquid as you should.

What Are Reasons I Shouldn't Take Salagen?

Salagen is not appropriate for everyone. You should not take this medication if you are allergic to pilocarpine or any of the inactive ingredients in Salagen.

Salagen may be used with caution in some people only if the healthcare provider determines it is safe. Salagen is not or may not be the best choice for you if you:

  • Have a known hypersensitivity or allergy to Salagen.
  • Have uncontrolled heart disease, as your body may be unable to handle the effects of pilocarpine, such as hypotension, hypertension, bradycardia, and tachycardia.
  • Have active peptic ulcer disease since pilocarpine may cause increased acid secretion.
  • Have uncontrolled asthma, as cholinergic drugs may cause bronchoconstriction and decreased airflow.

What Other Medications May Interact With Salagen?

There are some drugs that can interact with Salagen and should be monitored by your healthcare provider.

Examples of drugs that may potentially interact with Salagen include:

What Medications Are Similar to Salagen?

Other cholinergic agonist medications used to treat a variety of conditions include:

This is not a list of drugs recommended to take with Salagen. Ask your healthcare provider if you have questions.

Frequently Asked Questions

  • What is Salagen used for?

    Salagen is used to treat dry mouth caused by head and neck cancer radiation treatment or by Sjögren’s syndrome. An eye drop version of pilocarpine may also be used to treat high intraocular pressure, which is pressure inside the eye.

  • How long does it take for Salagen to work?

    It may take around 12 or more weeks of taking Salagen consistently before you start to see noticeable improvement in your dry mouth symptoms. Symptoms do improve over time, but some patience and consistency are required.

  • What are the side effects of Salagen?

    The most common side effect that people experience from Salagen is excess sweating, also called hyperhidrosis.

    Other common ones include headache, nausea, a runny or stuffy nose, flushing, and frequent urination. Other rare but possible side effects are heart effects like hypertension, hypotension, tachycardia, bradycardia, indigestion, and UTIs.

How Can I Stay Healthy While Taking Salagen?

Conditions caused by an overactive immune system–autoimmune diseases–are difficult to understand because our immune systems are so complicated. Of course, dealing with a cancer diagnosis and undergoing radiation treatment comes with a huge set of challenges.

Sjögren’s syndrome and radiation treatment both have profound impacts on your everyday life, and can cause symptoms that affect multiple parts of your body. It can be hard to work efficiently or enjoy things you normally do when you’re experiencing joint pain or dryness in areas like your eyes, nose, and mouth.

Sjögren’s syndrome is a very common autoimmune disease, affecting around 4 million Americans, predominantly women over 40. It can be hard to diagnose, given that symptoms may come and go and seem unrelated. Be sure to let your healthcare provider know any symptoms you are experiencing to help them make an accurate diagnosis.

Symptoms like dry mouth and dry eyes are some of the most common ones and can be some of the most uncomfortable parts of Sjögren’s, as well as a couple of examples of the many unpleasant side effects of radiation treatment. Fortunately, mouthwashes, lip balms, saliva substitutes, and gum can help relieve your dry mouth in addition to medicines like Salagen. At-home remedies like a humidifier may also help dryness in your eyes, nose, and mouth.

Working with your healthcare provider to come up with a treatment plan and sticking to it while prioritizing your mental, emotional and physical self-care can help you live as normal a life as possible with Sjögren’s syndrome or while receiving cancer radiation treatment.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

11 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Amdipharm Limited. Salagen (pilocarpine hydrochloride tablets) product monograph.

  2. Brown DA. Acetylcholine and cholinergic receptorsBrain Neurosci Adv. 2019;3:2398212818820506. doi:10.1177/2398212818820506

  3. Cheng SC, Wu VW, Kwong DL, Ying MT. Assessment of post-radiotherapy salivary glandsBr J Radiol. 2011;84(1001):393-402. doi:10.1259/bjr/66754762

  4. Stefanski AL, Tomiak C, Pleyer U, Dietrich T, Burmester GR, Dörner T. The diagnosis and treatment of Sjögren's syndromeDtsch Arztebl Int. 2017;114(20):354-361. doi:10.3238/arztebl.2017.0354

  5. Food and Drug Administration. Vuity (pilocarpine hydrochloride ophthalmic solution) prescribing information.

  6. MedlinePlus. Pilocarpine ophthalmic.

  7. Soutome S, Yanamoto S, Nishii M, et al. Risk factors for severe radiation-induced oral mucositis in patients with oral cancer. J Dent Sci. 2021;16(4):1241-1246.

  8. Pulito C, Cristaudo A, Porta C, et al. Oral mucositis: the hidden side of cancer therapyJ Exp Clin Cancer Res. 2020;39(1):210. doi:10.1186/s13046-020-01715-7

  9. Prescribers' Digital Reference. Pilocarpine hydrochloride - drug summary.

  10. University of Utah College of Pharmacy. Drug class review (2015). Ophthalmic cholinergic agonists.

  11. Angum F, Khan T, Kaler J, Siddiqui L, Hussain A. The prevalence of autoimmune disorders in women: a narrative reviewCureus. 2020;12(5):e8094. doi:10.7759/cureus.8094

By Sara Hoffman, PharmD
Sara is a clinical pharmacist that believes everyone should understand their medications, and aims to achieve this through her writing.