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.

Some side effects of Salagen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to pilocarpine: compounding crystal, oral tablet

Stop taking pilocarpine (the active ingredient contained in Salagen) and seek emergency medical attention if you experience any of the following uncommon but serious side effects:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• difficulty breathing;

• irregular heartbeats;

• eye pain; or

• confusion or changes in mental status or behavior.

Other, less serious side effects may also occur. Continue to take pilocarpine and talk to your doctor if you experience

• changes in vision;

• increased sweating;

• dizziness;

• headache;

• runny nose;

• nausea;

• redness of the face and neck;

• chills; or

• an increased urge to urinate.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

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

Gastrointestinal

Gastrointestinal side effects commonly reported have included nausea (6% to 15%), diarrhea (4% to 7%), dyspepsia (7%), abdominal pain (4%), and vomiting (4%). Anorexia, increased appetite, cholelithiasis, flatulence, gastritis, gastroenteritis, gastrointestinal disorder, and tongue disorder have been reported rarely.

Respiratory

Respiratory side effects have included rhinitis (5% to 14%), sinusitis (4%), and pharyngitis (2%). Esophagitis, increased sputum, stridor, yawning, bronchitis, dyspnea, hiccup, laryngismus, laryngitis, and voice alteration have been reported infrequently.

Endocrine

Endocrine side effects have included sweating (29% to 68%), lacrimation (6%), and increased salivation (3%).

Cardiovascular

Cardiovascular side effects have included hypertension (3%), angina pectoris, arrhythmia, electrocardiogram abnormality, hypotension, myocardial infarction, tachycardia, bradycardia, palpitations, and syncope.

Nervous system

Nervous system side effects commonly reported have included asthenia (6% to 12%) and dizziness (5% to 12%). Aphasia, confusion, abnormal dreams, hyperkinesia, hypesthesia, insomnia, myalgia, paresthesias, abnormal thinking, speech disorder, twitching, and tremor have been reported less frequently.

Ocular

Ocular side effects have included amblyopia, cataract, conjunctivitis, dry eyes, blurred vision, eye disorder, eye pain, eye hemorrhage, glaucoma, retinal disorder, and abnormal vision.

Genitourinary

Genitourinary side effects have included dysuria, metrorrhagia, urinary impairment, urinary incontinence, urinary tract infection, vaginitis, breast pain, mastitis, menorrhagia, ovarian disorder, pyuria, salpingitis, urethral pain, urinary urgency, vaginal hemorrhage, and vaginal moniliasis.

Psychiatric

Psychiatric side effects have included anxiety, confusion, depression, abnormal dreams, somnolence, emotional lability, insomnia, and nervousness.

Hematologic

Hematologic side effects have included leukopenia, lymphadenopathy, hematuria, abnormal platelets, thrombocythemia, thrombocytopenia, thrombosis, and abnormal WBC.

Metabolic

Metabolic side effects have included hypoglycemia.

Dermatologic

Dermatologic side effects have included seborrhea.

Other

Other infrequently reported side effects have included cyst, neck pain, neck rigidity, photosensitivity reaction, body odor, taste loss, taste perversion, voice alteration, tongue disorder, tooth disorder, increased cough, fever, and lab test abnormalities.

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