Salagen Side Effects

Generic name: pilocarpine

Medically reviewed by Drugs.com. Last updated on Oct 17, 2023.

Note: This document provides detailed information about Salagen Side Effects associated with pilocarpine. Some dosage forms listed on this page may not apply specifically to the brand name Salagen.

Applies to pilocarpine: oral tablet.

Common side effects of Salagen

Some side effects of pilocarpine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• chills
• cough
• diarrhea
• feeling of warmth or heat
• fever
• flushing or redness of skin especially on face and neck
• increased need to urinate
• indigestion
• joint pain
• muscle aches and pains
• nausea
• passing urine more often
• runny nose
• unusual tiredness or weakness
• Sweating

Less common or rare

• fast heartbeat
• headache
• holding more body water
• swelling of face, fingers, ankles, or feet
• trembling or shaking
• trouble swallowing
• trouble seeing
• unusual weak feeling
• voice change
• vomiting

Serious side effects of Salagen

Along with its needed effects, pilocarpine (the active ingredient contained in Salagen) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking pilocarpine:

Symptoms of overdose

• Chest pain
• confusion
• diarrhea (continuing or severe)
• fainting
• fast, slow, or irregular heartbeat (continuing or severe)
• headache (continuing or severe)
• nausea or vomiting (continuing or severe)
• shortness of breath or troubled breathing
• stomach cramps or pain
• tiredness or weakness (continuing or severe)
• trembling or shaking (continuing or severe)
• trouble seeing (continuing or severe)

For healthcare professionals

Applies to pilocarpine: compounding crystal, compounding powder, oral tablet.

General

The most commonly reported side effects included sweating, nausea, chills, and rhinitis.^[Ref]

Dermatologic

• Very common (10% or more): Sweating (up to 68%)
• Common (1% to 10%): Face edema, pruritus, rash
• Rare (less than 1%): Alopecia, body odor, dry skin, eczema, exfoliative dermatitis, seborrhea, vesiculobullous rash
• Frequency not reported: Dermatitis, photosensitivity reaction^[Ref]

Sweating occurred in up to 68% of patients with head and neck cancer given 10 mg orally 3 times a day; the side effect occurred in up to 29% of patients with head and neck cancer given 5 mg orally 3 times a day. Sweating occurred in up to 40% of patients with Sjogren's syndrome.^[Ref]

Other

• Very common (10% or more): Chills (up to 15%) asthenia (up to 12%)
• Common (1% to 10%): Accidental injury, fever, pain, tinnitus
• Rare (less than 1%): Deafness, ear disorder, ear pain, hypothermia, mucous membrane abnormality
• Frequency not reported: Death, middle ear disturbance^[Ref]

Asthenia occurred in up to 12% of patients with head and neck cancer given 10 mg orally 3 times a day; the side effect occurred in up to 6% of patients with head and neck cancer given 5 mg orally 3 times a day. Asthenia occurred in up to 4% of patients with Sjogren's syndrome.

Chills occurred in up to 15% of patients with head and neck cancer given 10 mg orally 3 times a day; the side effect occurred in up to 3% of patients with head and neck cancer given 5 mg orally 3 times a day. Asthenia occurred in up to 2% of patients with Sjogren's syndrome.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 15%)
• Common (1% to 10%): Abdominal pain, constipation, diarrhea, dyspepsia, dysphagia, flatulence, glossitis, increased salivation, stomatitis, vomiting
• Rare (less than 1%): Colitis, dry mouth, eructation, esophagitis, gastritis, gastroenteritis, gastrointestinal disorder, gingivitis, hiccup, melena, pancreatitis, parotid gland enlargement, salivary gland enlargement, tongue disorder, tooth disorder
• Frequency not reported: Gastrointestinal spasm^[Ref]

Nausea occurred in up to 15% of patients with head and neck cancer given 10 mg orally 3 times a day; the side effect occurred in up to 6% of patients with head and neck cancer given 5 mg orally 3 times a day. Nausea occurred in up to 9% of patients with Sjogren's syndrome.

Patients 65 years and older reported diarrhea approximately 2 times more than younger patients.

Dyspepsia occurred in up to 7% of patients with either Sjogren's syndrome or head and neck cancer.^[Ref]

Respiratory

• Very common (10% or more): Rhinitis (up to 14%)
• Common (1% to 10%): Increased cough, pharyngitis, sinusitis
• Rare (less than 1%): Bronchitis, dyspnea, increased sputum, laryngismus, laryngitis, pneumonia, stridor, yawning
• Frequency not reported: Respiratory distress^[Ref]

Rhinitis occurred in up to 14% of patients with head and neck cancer given 10 mg orally 3 times a day; the side effect occurred in up to 5% of patients with head and neck cancer given 5 mg orally 3 times a day. Rhinitis occurred in up to 7% of patients with Sjogren's syndrome.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 13%), dizziness (up to 12%)
• Common (1% to 10%): Somnolence, taste perversion, tremor
• Rare (less than 1%): hyperkinesia, hypesthesia, intracranial hemorrhage, migraine, myasthenia, paresthesia, speech disorder, syncope, taste loss
• Frequency not reported: eyelid twitching, memory loss^[Ref]

Dizziness occurred in up to 12% of patients with head and neck cancer given 10 mg orally 3 times a day; the side effect occurred in up to 5% of patients with head and neck cancer given 5 mg orally 3 times a day. Dizziness occurred in up to 6% of patients with Sjogren's syndrome. Patients 65 years and older reported dizziness approximately 3 times more than younger patients.

Headache occurred in up to 13% of patients with Sjogren's syndrome, and up to 11% in patients with head and neck cancer.^[Ref]

Cardiovascular

• Very common (10% or more): Flushing (up to 13%)
• Common (1% to 10%): Edema, epistaxis, hypertension, palpitations, tachycardia, vasodilation
• Rare (less than 1%): Bradycardia, ECG abnormality, peripheral edema, skin ulcer, thrombosis
• Frequency not reported: Angina pectoris, arrhythmia, atrioventricular block, cardiac arrhythmia, chest pain, hypotension, myocardial infarct/myocardial infarction, shock^[Ref]

Flushing occurred in up to 13% of patients with head and neck cancer given 10 mg orally 3 times a day; the side effect occurred in up to 8% of patients with head and neck cancer given 5 mg orally 3 times a day. Flushing occurred in up to 9% of patients with Sjogren's syndrome.^[Ref]

Genitourinary

• Very common (10% or more): Urinary frequency (up to 12%)
• Common (1% to 10%): Urinalysis abnormalities, urinary incontinence, urinary tract infection, vaginitis
• Uncommon (0.1% to 1%): Urinary urgency
• Rare (less than 0.1%): Breast pain, dysuria, hematuria, mastitis, menorrhagia, metrorrhagia, ovarian disorder, salpingitis, urethral pain, urinary impairment, vaginal hemorrhage, vaginal moniliasis^[Ref]

Urinary frequency occurred in up to 12% of patients with head and neck cancer given 10 mg orally 3 times a day; the side effect occurred in up to 9% of patients with head and neck cancer given 5 mg orally 3 times a day. Urinary frequency occurred in up to 10% of patients with Sjogren's syndrome. Patients 65 years and older reported urinary frequency approximately 2 times more than younger patients.^[Ref]

Ocular

• Common (1% to 10%): Abnormal vision, amblyopia, blurred vision, conjunctivitis, eye pain, lacrimation/lacrimation disorder
• Rare (less than 1%): Cataract, dry eyes, eye disorder, eye hemorrhage, glaucoma, retinal disorder
• Frequency not reported: Ciliary congestion, iris cyst, macular hole, malignant glaucoma^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, myalgias
• Rare (less than 1%): Arthralgia, arthritis, bone disorder, leg cramps, tendon disorder, tenosynovitis, twitching
• Frequency not reported: Neck pain, neck rigidity^[Ref]

Immunologic

• Common (1% to 10%): Flu syndrome, infection
• Rare (less than 1%): Erythema nodosum, herpes simplex, moniliasis, pyuria, viral infection
• Frequency not reported: Contact dermatitis^[Ref]

Psychiatric

• Common (1% to 10%): Voice alteration
• Rare (less than 1%): Abnormal dreams, abnormal thinking, anxiety, aphasia, confusion, depression, emotional lability, insomnia, nervousness
• Frequency not reported: Affect lability, agitation, delusion, hallucinations, mental status changes, visual hallucinations^[Ref]

Hematologic

• Common (1% to 10%): Abnormal hematology tests
• Rare (less than 1%): Abnormal platelets, abnormal WBC, leukopenia, lymphadenopathy, thrombocythemia, thrombocytopenia^[Ref]

Metabolic

• Common (1% to 10%): Lab chemistry test abnormalities
• Rare (less than 1%): Anorexia, hypoglycemia, increased appetite^[Ref]

Hypersensitivity

• Common (1% to 10%): Allergic reactions^[Ref]

Hepatic

• Rare (less than 1%): Abnormal liver function tests, bilirubinemia, cholelithiasis, hepatitis^[Ref]

Oncologic

• Rare (less than 1%): Pathological fracture, spontaneous bone fracture
• Frequency not reported: Cyst^[Ref]

Further information

Salagen side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer