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Salagen Side Effects

Generic Name: pilocarpine

Note: This document contains side effect information about pilocarpine. Some of the dosage forms listed on this page may not apply to the brand name Salagen.

In Summary

Common side effects of Salagen include: asthenia, dizziness, nausea, urinary frequency, headache, rhinitis, chills, diaphoresis, and flushing. Other side effects include: diarrhea, lacrimation, and vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to pilocarpine: oral tablet

Side effects requiring immediate medical attention

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)

Side effects not requiring immediate medical attention

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

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

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]

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]

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]

References

1. "Product Information. Salagen Tablets (pilocarpine)." Boehringer-Ingelheim, Ridgefield, CT.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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.