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Pilocarpine (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 pilocarpine hydrochloride tablets were a consequence of the expected pharmacologic effects of pilocarpine.

Adverse Event Pilocarpine HCl Placebo
10 mg t.i.d.
(30 mg/day)
5 mg t.i.d.
(15 mg/day)
(t.i.d.)
N=121 N=141 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)
(t.i.d.)
N=212 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, parethesias, 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 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 in 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 pilocarpine hydrochloride tablets:

Adverse Event Pilocarpine HCl Placebo
5 mg q.i.d.
(20 mg/day)
(q.i.d.)
N=255 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)
(q.i.d.)
N=255 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, 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.



REPORTS OF SUSPECTED PILOCARPINE SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Pilocarpine side effects / adverse reactions in 67 year old male

Reported by a physician from China on 2011-10-19

Patient: 67 year old male

Reactions: Iris Disorder, Anterior Chamber Inflammation, Drug Ineffective, Iris Bombe, Iris Adhesions, Intraocular Pressure Test Abnormal

Suspect drug(s):
Pilocarpine
    Indication: Intraocular Pressure Increased

Timolol Maleate
    Indication: Intraocular Pressure Increased



Possible Pilocarpine side effects / adverse reactions in 67 year old male

Reported by a physician from China on 2011-10-20

Patient: 67 year old male

Reactions: Anterior Chamber Inflammation, Iris Disorder, Drug Ineffective, Iris Bombe, Iris Adhesions, Intraocular Pressure Test Abnormal

Suspect drug(s):
Pilocarpine
    Indication: Intraocular Pressure Increased

Timolol Maleate
    Indication: Intraocular Pressure Increased



Possible Pilocarpine side effects / adverse reactions in 60 year old male

Reported by a pharmacist from United States on 2011-11-04

Patient: 60 year old male weighing 49.9 kg (109.8 pounds)

Reactions: Post Procedural Complication, Anaphylactic Reaction, Allergy Test Positive

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Pilocarpine
    Indication: Surgery
    Start date: 2011-04-21
    End date: 2011-04-22

Pilocarpine
    Indication: Surgery
    Start date: 2011-04-21
    End date: 2011-04-22



See index of all Pilocarpine side effect reports >>

Drug label data at the top of this Page last updated: 2014-05-30

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