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Salagen (Pilocarpine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Head & Neck Cancer Patients:    In controlled studies, 217 patients received pilocarpine, of whom 68% were men and 32% were women. Race distribution was 91% Caucasian, 8% Black, and 1% of other origin. Mean age was approximately 58 years. The majority of patients were between 50 and 64 years (51%), 33% were 65 years and older and 16% were younger than 50 years of age.

The most frequent adverse experiences associated with SALAGEN® Tablets were a consequence of the expected pharmacologic effects of pilocarpine.

Adverse Event Pilocarpine HCl Placebo
10 mg t.i.d.
(30 mg/day)
N=121
5 mg t.i.d.
(15 mg/day)
N=141
(t.i.d.)
  
N=152
Sweating   68%   29%   9%
Nausea 15 6 4
Rhinitis 14 5 7
Diarrhea   7 4 5
Chills 15 3 <1   
Flushing 13 8 3
Urinary
   Frequency
12 9 7
Dizziness 12 5 4
Asthenia 12 6 3

In addition, the following adverse events (>/=3% incidence) were reported at dosages of 15-30 mg/day in the controlled clinical trials:

Adverse Event Pilocarpine HCl Placebo
5-10 mg t.i.d.
(15-30 mg/day)
N=212
(t.i.d.)
  
N=152
Headache   11%   8%
Dyspepsia 7 5
Lacrimation 6 8
Edema 5 4
Abdominal Pain 4 4
Amblyopia 4 2
Vomiting 4 1
Pharyngitis 3 8
Hypertension 3 1

The following events were reported with treated head and neck cancer patients at incidences of 1% to 2% at dosages of 7.5 to 30 mg/day: abnormal vision, conjunctivitis, dysphagia, epistaxis, myalgias, pruritus, rash, sinusitis, tachycardia, taste perversion, tremor, voice alteration.

The following events were reported rarely in treated head and neck cancer patients (<1%):

Causal relation is unknown.

Body as a whole:   body odor, hypothermia, mucous membrane abnormality

Cardiovascular:   bradycardia, ECG abnormality, palpitations, syncope

Digestive:   anorexia, increased appetite, esophagitis, gastrointestinal disorder, tongue disorder

Hematologic:   leukopenia, lymphadenopathy

Nervous:   anxiety, confusion, depression, abnormal dreams, hyperkinesia, hypesthesia, nervousness,
      paresthesias, speech disorder, twitching

Respiratory:   increased sputum, stridor, yawning

Skin:   seborrhea

Special senses:   deafness, eye pain, glaucoma

Urogenital:   dysuria, metrorrhagia, urinary impairment

In long-term treatment were two patients with underlying cardiovascular disease of whom one experienced a myocardial infarct and another an episode of syncope. The association with drug is uncertain.

Sjogren's Syndrome Patients:    In controlled studies, 376 patients received pilocarpine, of whom 5% were men and 95% were women. Race distribution was 84% Caucasian, 9% Oriental, 3% Black, and 4% of other origin. Mean age was 55 years. The majority of patients were between 40 and 69 years (70%), 16% were 70 years and older and 14% were younger than 40 years of age. Of these patients, 161/629 (89/376 receiving pilocarpine) were over the age of 65 years. The adverse events reported by those over 65 years and those 65 years and younger were comparable except for notable trends for urinary frequency, diarrhea, and dizziness. The incidences of urinary frequency and diarrhea in the elderly were about double those of the non-elderly. The incidence of dizziness was about three times as high in the elderly as in the non-elderly. These adverse experiences were not considered to be serious. In the 2 placebo-controlled studies, the most common adverse events related to drug use were sweating, urinary frequency, chills, and vasodilatation (flushing). The most commonly reported reason for patient discontinuation of treatment was sweating. Expected pharmacologic effects of pilocarpine include the following adverse experiences associated with SALAGEN® Tablets:

Adverse Event Pilocarpine HCl Placebo
5 mg q.i.d.
(20 mg/day)
N=255
(q.i.d.)
  
N=253
Sweating 40% 7%
Urinary Frequency 10 4
Nausea 9 9
Flushing 9 2
Rhinitis 7 8
Diarrhea 6 7
Chills 4 2
Increased Salivation 3 0
Asthenia 2 2

In addition, the following adverse events (>/=3% incidence) were reported at dosages of 20 mg/day in the controlled clinical trials:

Adverse Event Pilocarpine HCl Placebo
5 mg q.i.d.
(20 mg/day)
N=255
(q.i.d.)
  
N=253
Headache 13% 19%
Flu Syndrome 9 9
Dyspepsia 7 7
Dizziness 6 7
Pain 4 2
Sinusitis 4 5
Abdominal Pain 3 4
Vomiting 3 1
Pharyngitis 2 5
Rash 2 3
Infection 2 6

The following events were reported in Sjogren's patients at incidences of 1% to 2% at dosing of 20 mg/day: accidental injury, allergic reaction, back pain, blurred vision, constipation, increased cough, edema, epistaxis, face edema, fever, flatulence, glossitis, lab test abnormalities, including chemistry, hematology, and urinalysis, myalgia, palpitation, pruritus, somnolence, stomatitis, tachycardia, tinnitus, urinary incontinence, urinary tract infection, and vaginitis.

The following events were reported rarely in treated Sjogren's patients (<1%) at dosing of 10-30 mg/day: Causal relation is unknown.

Body as a whole:   chest pain, cyst, death, moniliasis, neck pain, neck rigidity, photosensitivity reaction

Cardiovascular:   angina pectoris, arrhythmia, ECG abnormality, hypotension, hypertension,
      intracranial hemorrhage, migraine, myocardial infarction

Digestive:   anorexia, bilirubinemia, cholelithiasis, colitis, dry mouth, eructation, gastritis,
      gastroenteritis, gastrointestinal disorder, gingivitis, hepatitis, abnormal liver function tests,
     melena, nausea & vomiting, pancreatitis, parotid gland enlargement, salivary gland enlargement,
     sputum increased, taste loss, tongue disorder, tooth disorder

Hematologic:   hematuria, lymphadenopathy, abnormal platelets, thrombocythemia, thrombocytopenia,
     thrombosis, abnormal WBC

Metabolic and Nutritional:   peripheral edema, hypoglycemia

Musculoskeletal:   arthralgia, arthritis, bone disorder, spontaneous bone fracture, pathological fracture,
     myasthenia, tendon disorder, tenosynovitis

Nervous:   aphasia, confusion, depression, abnormal dreams, emotional lability, hyperkinesia,
     hypesthesia, insomnia, leg cramps, nervousness, parethesias, abnormal thinking, tremor

Respiratory:   bronchitis, dyspnea, hiccup, laryngismus, laryngitis, pneumonia, viral infection, voice alteration

Skin:   alopecia, contact dermatitis, dry skin, eczema, erythema nodosum, exfoliative dermatitis,
     herpes simplex, skin ulcer, vesiculobullous rash

Special Senses:   cataract, conjunctivitis, dry eyes, ear disorder, ear pain, eye disorder, eye hemorrhage,
      glaucoma, lacrimation disorder, retinal disorder, taste perversion, abnormal vision

Urogenital:   breast pain, dysuria, mastitis, menorrhagia, metrorrhagia, ovarian disorder, pyuria,
     salpingitis, urethral pain, urinary urgency, vaginal hemorrhage, vaginal moniliasis

The following adverse experiences have been reported rarely with ocular pilocarpine: A-V block, agitation, ciliary congestion, confusion, delusion, depression, dermatitis, middle ear disturbance, eyelid twitching, malignant glaucoma, iris cysts, macular hole, shock, and visual hallucination.

MANAGEMENT OF OVERDOSE:    Fatal overdosage with pilocarpine has been reported in the scientific literature at doses presumed to be greater than 100 mg in two hospitalized patients. 100 mg of pilocarpine is considered potentially fatal. Overdosage should be treated with atropine titration (0.5 mg to 1.0 mg given subcutaneously or intravenously) and supportive measures to maintain respiration and circulation. Epinephrine (0.3 mg to 1.0 mg, subcutaneously or intramuscularly) may also be of value in the presence of severe cardiovascular depression or bronchoconstriction. It is not known if pilocarpine is dialyzable.



REPORTS OF SUSPECTED SALAGEN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Salagen. The information is not vetted and should not be considered as verified clinical evidence.

Possible Salagen side effects / adverse reactions in 83 year old male

Reported by a consumer/non-health professional from United States on 2011-11-16

Patient: 83 year old male

Reactions: Speech Disorder, Fatigue, Drug Ineffective, Hemiparesis, Hyperhidrosis, Micturition Urgency, Cerebral Haemorrhage

Suspect drug(s):
Salagen

Other drugs received by patient: Gabapentin; Lithium Carbonate



Possible Salagen side effects / adverse reactions in 55 year old female

Reported by a physician from United States on 2012-01-25

Patient: 55 year old female weighing 66.0 kg (145.2 pounds)

Reactions: Product Compounding Quality Issue, Reaction TO Drug Excipients

Suspect drug(s):
Salagen
    Indication: Sjogren's Syndrome
    Start date: 2011-09-01

Flexeril
    Indication: Fibromyalgia

Other drugs received by patient: Mobic; Vivelle-DOT



Possible Salagen side effects / adverse reactions in 83 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-09

Patient: 83 year old female

Reactions: Hypothermia, Hyperhidrosis, Tremor

Adverse event resulted in: hospitalization

Suspect drug(s):
Salagen

Other drugs received by patient: Nicergoline; Enalapril Maleate; Gasgel; Itopride Hydrochloride; Pantethine; Chlorpropamide; Rheum Palmatum; Vemas S; Nitrendipine; Ledolper; Miya-BM; Magmitt Kenei



See index of all Salagen side effect reports >>

Drug label data at the top of this Page last updated: 2006-12-08

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