Drug information for SALAGEN
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
5MG
Prescription
AB
PILOCARPINE HYDROCHLORIDE
Pilocarpine
EISAI INC
20237
2007-07-06 Review
2004-06-07 Letter
2004-06-07 Letter
2003-05-29 Letter
2003-04-28 Label
2002-06-10 Letter
2002-06-10 Label
2002-06-10 Letter
2002-06-10 Label
1998-02-11 Letter
1998-02-11 Review
TABLET; ORAL
7.5MG
Prescription
AB (Reference Drug)
PILOCARPINE HYDROCHLORIDE
Pilocarpine
EISAI INC
"
Drug Adverse Effects information for SALAGEN
Role code
Indications
Reaction
# Reports
PS
BENIGN PROSTATIC HYPERPLASIA
ANGIOPATHY
1
PS
BENIGN PROSTATIC HYPERPLASIA
CAROTID ARTERIOSCLEROSIS
1
PS
BENIGN PROSTATIC HYPERPLASIA
DRUG INEFFECTIVE
1
PS
BENIGN PROSTATIC HYPERPLASIA
FATIGUE
1
PS
BENIGN PROSTATIC HYPERPLASIA
HEMIPARESIS
1
PS
BENIGN PROSTATIC HYPERPLASIA
HYPERHIDROSIS
1
PS
BENIGN PROSTATIC HYPERPLASIA
MICTURITION URGENCY
1
PS
BENIGN PROSTATIC HYPERPLASIA
PUTAMEN HAEMORRHAGE
1
PS
BENIGN PROSTATIC HYPERPLASIA
SENSATION OF HEAVINESS
1
PS
BENIGN PROSTATIC HYPERPLASIA
SENSORY LOSS
1
PS
BENIGN PROSTATIC HYPERPLASIA
SPEECH DISORDER
1
PS
BENIGN PROSTATIC HYPERPLASIA
TRANSIENT ISCHAEMIC ATTACK
1
PS
BENIGN PROSTATIC HYPERPLASIA
VASOGENIC CEREBRAL OEDEMA
1
PS
BIPOLAR DISORDER
ANGIOPATHY
1
PS
BIPOLAR DISORDER
CAROTID ARTERIOSCLEROSIS
1
PS
BIPOLAR DISORDER
DRUG INEFFECTIVE
1
PS
BIPOLAR DISORDER
FATIGUE
1
PS
BIPOLAR DISORDER
HEMIPARESIS
1
PS
BIPOLAR DISORDER
HYPERHIDROSIS
1
PS
BIPOLAR DISORDER
MICTURITION URGENCY
1
PS
BIPOLAR DISORDER
PUTAMEN HAEMORRHAGE
1
PS
BIPOLAR DISORDER
SENSATION OF HEAVINESS
1
PS
BIPOLAR DISORDER
SENSORY LOSS
1
PS
BIPOLAR DISORDER
SPEECH DISORDER
1
PS
BIPOLAR DISORDER
TRANSIENT ISCHAEMIC ATTACK
1
PS
BIPOLAR DISORDER
VASOGENIC CEREBRAL OEDEMA
1
PS
DEPRESSION
ANGIOPATHY
1
PS
DEPRESSION
CAROTID ARTERIOSCLEROSIS
1
PS
DEPRESSION
CEREBRAL HAEMORRHAGE
1
PS
DEPRESSION
DRUG INEFFECTIVE
2
PS
DEPRESSION
FATIGUE
2
PS
DEPRESSION
HEMIPARESIS
2
PS
DEPRESSION
HYPERHIDROSIS
2
PS
DEPRESSION
MICTURITION URGENCY
2
PS
DEPRESSION
PUTAMEN HAEMORRHAGE
1
PS
DEPRESSION
SENSATION OF HEAVINESS
1
PS
DEPRESSION
SENSORY LOSS
1
PS
DEPRESSION
SPEECH DISORDER
2
PS
DEPRESSION
TRANSIENT ISCHAEMIC ATTACK
1
PS
DEPRESSION
VASOGENIC CEREBRAL OEDEMA
1
PS
DRY MOUTH
ANGIOPATHY
1
PS
DRY MOUTH
CAROTID ARTERIOSCLEROSIS
1
PS
DRY MOUTH
CEREBRAL HAEMORRHAGE
1
PS
DRY MOUTH
DRUG INEFFECTIVE
2
PS
DRY MOUTH
FATIGUE
2
PS
DRY MOUTH
HEMIPARESIS
2
PS
DRY MOUTH
HYPERHIDROSIS
2
PS
DRY MOUTH
MICTURITION URGENCY
2
PS
DRY MOUTH
PUTAMEN HAEMORRHAGE
1
PS
DRY MOUTH
SENSATION OF HEAVINESS
1
PS
DRY MOUTH
SENSORY LOSS
1
PS
DRY MOUTH
SPEECH DISORDER
2
PS
DRY MOUTH
TRANSIENT ISCHAEMIC ATTACK
1
PS
DRY MOUTH
VASOGENIC CEREBRAL OEDEMA
1
PS
MUSCLE CONTRACTIONS INVOLUNTARY
ANGIOPATHY
1
PS
MUSCLE CONTRACTIONS INVOLUNTARY
CAROTID ARTERIOSCLEROSIS
1
PS
MUSCLE CONTRACTIONS INVOLUNTARY
CEREBRAL HAEMORRHAGE
1
PS
MUSCLE CONTRACTIONS INVOLUNTARY
DRUG INEFFECTIVE
2
PS
MUSCLE CONTRACTIONS INVOLUNTARY
FATIGUE
2
PS
MUSCLE CONTRACTIONS INVOLUNTARY
HEMIPARESIS
2
PS
MUSCLE CONTRACTIONS INVOLUNTARY
HYPERHIDROSIS
2
PS
MUSCLE CONTRACTIONS INVOLUNTARY
MICTURITION URGENCY
2
PS
MUSCLE CONTRACTIONS INVOLUNTARY
PUTAMEN HAEMORRHAGE
1
PS
MUSCLE CONTRACTIONS INVOLUNTARY
SENSATION OF HEAVINESS
1
PS
MUSCLE CONTRACTIONS INVOLUNTARY
SENSORY LOSS
1
PS
MUSCLE CONTRACTIONS INVOLUNTARY
SPEECH DISORDER
2
PS
MUSCLE CONTRACTIONS INVOLUNTARY
TRANSIENT ISCHAEMIC ATTACK
1
PS
MUSCLE CONTRACTIONS INVOLUNTARY
VASOGENIC CEREBRAL OEDEMA
1
PS
RESTLESS LEGS SYNDROME
ANGIOPATHY
1
PS
RESTLESS LEGS SYNDROME
CAROTID ARTERIOSCLEROSIS
1
PS
RESTLESS LEGS SYNDROME
DRUG INEFFECTIVE
1
PS
RESTLESS LEGS SYNDROME
FATIGUE
1
PS
RESTLESS LEGS SYNDROME
HEMIPARESIS
1
PS
RESTLESS LEGS SYNDROME
HYPERHIDROSIS
1
PS
RESTLESS LEGS SYNDROME
MICTURITION URGENCY
1
PS
RESTLESS LEGS SYNDROME
PUTAMEN HAEMORRHAGE
1
PS
RESTLESS LEGS SYNDROME
SENSATION OF HEAVINESS
1
PS
RESTLESS LEGS SYNDROME
SENSORY LOSS
1
PS
RESTLESS LEGS SYNDROME
SPEECH DISORDER
1
PS
RESTLESS LEGS SYNDROME
TRANSIENT ISCHAEMIC ATTACK
1
PS
RESTLESS LEGS SYNDROME
VASOGENIC CEREBRAL OEDEMA
1
C
ASTHMA
DYSPNOEA
1
C
ASTHMA
NAUSEA
1
C
ASTHMA
PRODUCT QUALITY ISSUE
1
C
BREAST CANCER
ABDOMINAL PAIN
5
C
BREAST CANCER
ACETABULUM FRACTURE
5
C
BREAST CANCER
ACTINIC KERATOSIS
4
C
BREAST CANCER
ANAEMIA
5
C
BREAST CANCER
ANXIETY
1
C
BREAST CANCER
ARTHRALGIA
5
C
BREAST CANCER
BACK PAIN
5
C
BREAST CANCER
BONE LESION
1
C
BREAST CANCER
BONE PAIN
5
C
BREAST CANCER
BRONCHITIS
4
C
BREAST CANCER
BURSITIS
5
C
BREAST CANCER
CARDIOMYOPATHY
4
C
BREAST CANCER
CATARACT
4
C
BREAST CANCER
CHEST PAIN
5
C
BREAST CANCER
COAGULOPATHY
5
C
BREAST CANCER
CONFUSIONAL STATE
5
C
BREAST CANCER
CONSTIPATION
5
C
BREAST CANCER
CONTUSION
1
C
BREAST CANCER
CONVULSION
5
C
BREAST CANCER
DEATH
5
C
BREAST CANCER
DECREASED APPETITE
5
C
BREAST CANCER
DEFORMITY
5
C
BREAST CANCER
DRY EYE
4
C
BREAST CANCER
DRY MOUTH
5
C
BREAST CANCER
DYSPEPSIA
5
C
BREAST CANCER
DYSPHAGIA
5
C
BREAST CANCER
DYSPNOEA
5
C
BREAST CANCER
EPISTAXIS
5
C
BREAST CANCER
FATIGUE
5
C
BREAST CANCER
GASTROOESOPHAGEAL REFLUX DISEASE
4
C
BREAST CANCER
HAEMANGIOMA
4
C
BREAST CANCER
HEPATIC LESION
4
C
BREAST CANCER
HERPES ZOSTER
5
C
BREAST CANCER
HYPERCHOLESTEROLAEMIA
4
C
BREAST CANCER
HYPERTENSION
5
C
BREAST CANCER
HYPOAESTHESIA
5
C
BREAST CANCER
HYPOKALAEMIA
5
C
BREAST CANCER
HYPOMAGNESAEMIA
5
C
BREAST CANCER
INFECTION
5
C
BREAST CANCER
INSOMNIA
5
C
BREAST CANCER
JOINT EFFUSION
5
C
BREAST CANCER
LACRIMATION INCREASED
1
C
BREAST CANCER
LARYNGITIS
4
C
BREAST CANCER
LEUKOPENIA
4
C
BREAST CANCER
LUNG INFILTRATION
4
C
BREAST CANCER
METABOLIC DISORDER
5
C
BREAST CANCER
METASTASES TO CENTRAL NERVOUS SYSTEM
5
C
BREAST CANCER
MUSCULAR WEAKNESS
4
C
BREAST CANCER
MUSCULOSKELETAL PAIN
5
C
BREAST CANCER
NASAL CONGESTION
2
C
BREAST CANCER
NAUSEA
5
C
BREAST CANCER
NEURITIS
5
C
BREAST CANCER
NEUROPATHY PERIPHERAL
5
C
BREAST CANCER
OESOPHAGITIS
5
C
BREAST CANCER
ONYCHOMYCOSIS
4
C
BREAST CANCER
OROPHARYNGEAL PAIN
4
C
BREAST CANCER
OSTEONECROSIS OF JAW
5
C
BREAST CANCER
PAIN
5
C
BREAST CANCER
PATHOLOGICAL FRACTURE
5
C
BREAST CANCER
PLEURAL EFFUSION
5
C
BREAST CANCER
PLEURAL FIBROSIS
4
C
BREAST CANCER
PNEUMONIA
4
C
BREAST CANCER
POLYNEUROPATHY
5
C
BREAST CANCER
PRURITUS
5
C
BREAST CANCER
PULMONARY EMBOLISM
5
C
BREAST CANCER
RADICULITIS BRACHIAL
5
C
BREAST CANCER
RADICULOPATHY
5
C
BREAST CANCER
RESPIRATORY DISTRESS
3
C
BREAST CANCER
RESPIRATORY FAILURE
5
C
BREAST CANCER
SEBORRHOEIC KERATOSIS
4
C
BREAST CANCER
SINUSITIS
4
C
BREAST CANCER
SKIN LESION
4
C
BREAST CANCER
SMALL INTESTINAL OBSTRUCTION
4
C
BREAST CANCER
SPINAL CORD COMPRESSION
3
C
BREAST CANCER
SPINAL OSTEOARTHRITIS
5
C
BREAST CANCER
SPONDYLOLISTHESIS
5
C
BREAST CANCER
STOMATITIS
5
C
BREAST CANCER
SYNOVIAL CYST
5
C
BREAST CANCER
TEMPERATURE INTOLERANCE
5
C
BREAST CANCER
THROMBOCYTOPENIA
5
C
BREAST CANCER
UPPER RESPIRATORY TRACT INFECTION
4
C
BREAST CANCER
VARICELLA
5
C
BREAST CANCER
VOMITING
5
C
BREAST CANCER
WHITE BLOOD CELL COUNT DECREASED
5
C
CROHN'S DISEASE
COLOSTOMY CLOSURE
1
C
CROHN'S DISEASE
POST PROCEDURAL INFECTION
1
C
DIABETES MELLITUS
BLOOD SODIUM ABNORMAL
1
C
DIABETES MELLITUS
BRONCHIAL HYPERREACTIVITY
1
C
DIABETES MELLITUS
CONFUSIONAL STATE
1
C
DIABETES MELLITUS
DYSPNOEA
1
C
DIABETES MELLITUS
HYPERTENSION
1
C
DIABETES MELLITUS
HYPONATRAEMIA
1
C
DIABETES MELLITUS
MALAISE
1
C
DIABETES MELLITUS
OEDEMA PERIPHERAL
1
C
DIABETES MELLITUS
OVERDOSE
1
C
DIABETES MELLITUS
PNEUMONIA
1
C
DIABETES MELLITUS
POLYURIA
1
C
DIABETES MELLITUS
WEIGHT INCREASED
1
C
LUPUS NEPHRITIS
BILIARY CIRRHOSIS PRIMARY
1
C
LUPUS NEPHRITIS
BLOOD ALKALINE PHOSPHATASE INCREASED
2
C
LUPUS NEPHRITIS
BLOOD CREATININE INCREASED
2
C
LUPUS NEPHRITIS
BLOOD PRESSURE INCREASED
2
C
LUPUS NEPHRITIS
CARDIAC TAMPONADE
2
C
LUPUS NEPHRITIS
CONDITION AGGRAVATED
2
C
LUPUS NEPHRITIS
DECREASED APPETITE
2
C
LUPUS NEPHRITIS
DISEASE COMPLICATION
1
C
LUPUS NEPHRITIS
DISEASE RECURRENCE
1
C
LUPUS NEPHRITIS
GAMMA-GLUTAMYLTRANSFERASE INCREASED
2
C
LUPUS NEPHRITIS
HAEMODIALYSIS
2
C
LUPUS NEPHRITIS
LUPUS NEPHRITIS
1
C
LUPUS NEPHRITIS
NEPHROGENIC ANAEMIA
2
C
LUPUS NEPHRITIS
NO THERAPEUTIC RESPONSE
1
C
LUPUS NEPHRITIS
PERICARDIAL EFFUSION
1
C
LUPUS NEPHRITIS
PLATELET COUNT DECREASED
2
C
LUPUS NEPHRITIS
RASH
1
C
LUPUS NEPHRITIS
RENAL FAILURE CHRONIC
2
C
LUPUS NEPHRITIS
SYSTEMIC LUPUS ERYTHEMATOSUS
2
C
METASTASES TO BONE
ADRENAL ADENOMA
6
C
METASTASES TO BONE
AMNESIA
6
C
METASTASES TO BONE
ANAEMIA
6
C
METASTASES TO BONE
ANAEMIA OF MALIGNANT DISEASE
6
C
METASTASES TO BONE
ANHEDONIA
6
C
METASTASES TO BONE
ANXIETY
6
C
METASTASES TO BONE
ARTERIOSCLEROSIS
6
C
METASTASES TO BONE
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
6
C
METASTASES TO BONE
AXILLARY MASS
6
C
METASTASES TO BONE
BACK PAIN
6
C
METASTASES TO BONE
BACTERIAL TEST NEGATIVE
6
C
METASTASES TO BONE
BLOOD POTASSIUM DECREASED
6
C
METASTASES TO BONE
BONE DISORDER
6
C
METASTASES TO BONE
BONE LESION
6
C
METASTASES TO BONE
BONE MARROW FAILURE
6
C
METASTASES TO BONE
BRACHIAL PLEXOPATHY
6
C
METASTASES TO BONE
BREAST CANCER METASTATIC
6
C
METASTASES TO BONE
BRONCHITIS
3
C
METASTASES TO BONE
CERVICAL SPINAL STENOSIS
6
C
METASTASES TO BONE
CHEST PAIN
6
C
METASTASES TO BONE
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6
C
METASTASES TO BONE
CIRCADIAN RHYTHM SLEEP DISORDER
6
C
METASTASES TO BONE
COLONIC STENOSIS
6
C
METASTASES TO BONE
COMPRESSION FRACTURE
6
C
METASTASES TO BONE
DEAFNESS
6
C
METASTASES TO BONE
DEATH
6
C
METASTASES TO BONE
DENTAL CARIES
6
C
METASTASES TO BONE
DENTURE WEARER
6
C
METASTASES TO BONE
DEPRESSION
6
C
METASTASES TO BONE
DISABILITY
6
C
METASTASES TO BONE
DYSPNOEA
6
C
METASTASES TO BONE
EMPHYSEMA
6
C
METASTASES TO BONE
FASCIITIS
6
C
METASTASES TO BONE
FATIGUE
6
C
METASTASES TO BONE
GASTRITIS
6
C
METASTASES TO BONE
GRANULOCYTOPENIA
6
C
METASTASES TO BONE
HEART RATE IRREGULAR
6
C
METASTASES TO BONE
HYPERSOMNIA
6
C
METASTASES TO BONE
HYPOTHYROIDISM
6
C
METASTASES TO BONE
IMPAIRED HEALING
6
C
METASTASES TO BONE
INJURY
6
C
METASTASES TO BONE
INTERVERTEBRAL DISC PROTRUSION
6
C
METASTASES TO BONE
LEUKOPENIA
3
C
METASTASES TO BONE
LIP DRY
6
C
METASTASES TO BONE
MALNUTRITION
6
C
METASTASES TO BONE
MASTICATION DISORDER
6
C
METASTASES TO BONE
METASTASES TO BONE
6
C
METASTASES TO BONE
MUSCULOSKELETAL PAIN
6
C
METASTASES TO BONE
MUSCULOSKELETAL STIFFNESS
6
C
METASTASES TO BONE
NAUSEA
6
C
METASTASES TO BONE
NECK PAIN
6
C
METASTASES TO BONE
NEOPLASM MALIGNANT
6
C
METASTASES TO BONE
NEURALGIA
6
C
METASTASES TO BONE
NEUROPATHY PERIPHERAL
6
C
METASTASES TO BONE
OSTEOARTHRITIS
6
C
METASTASES TO BONE
OSTEONECROSIS OF JAW
6
C
METASTASES TO BONE
PAIN
6
C
METASTASES TO BONE
PANCOAST'S TUMOUR
6
C
METASTASES TO BONE
PANCYTOPENIA
6
C
METASTASES TO BONE
PLEURAL EFFUSION
6
C
METASTASES TO BONE
PRODUCTIVE COUGH
6
C
METASTASES TO BONE
PYREXIA
6
C
METASTASES TO BONE
RECTAL HAEMORRHAGE
6
C
METASTASES TO BONE
RED BLOOD CELLS URINE
6
C
METASTASES TO BONE
RESPIRATORY TRACT INFECTION
6
C
METASTASES TO BONE
RIB FRACTURE
6
C
METASTASES TO BONE
SENSITIVITY OF TEETH
6
C
METASTASES TO BONE
SPINAL OSTEOARTHRITIS
6
C
METASTASES TO BONE
STOMATITIS
6
C
METASTASES TO BONE
SYNCOPE
6
C
METASTASES TO BONE
TOOTH ABSCESS
6
C
METASTASES TO BONE
TOOTHACHE
6
C
METASTASES TO BONE
TREMOR
6
C
METASTASES TO BONE
URINARY INCONTINENCE
6
C
METASTASES TO BONE
URINARY TRACT INFECTION
6
C
METASTASES TO BONE
URINE ANALYSIS
6
C
METASTASES TO BONE
VOMITING
6
C
METASTASES TO BONE
WEIGHT DECREASED
6
C
METASTASES TO BONE
WHITE BLOOD CELL COUNT
6
C
OSTEOPOROSIS
BLOOD SODIUM ABNORMAL
1
C
OSTEOPOROSIS
BRONCHIAL HYPERREACTIVITY
1
C
OSTEOPOROSIS
CONFUSIONAL STATE
1
C
OSTEOPOROSIS
DYSPNOEA
1
C
OSTEOPOROSIS
HYPERTENSION
1
C
OSTEOPOROSIS
HYPONATRAEMIA
1
C
OSTEOPOROSIS
KNEE OPERATION
1
C
OSTEOPOROSIS
MALAISE
1
C
OSTEOPOROSIS
OEDEMA PERIPHERAL
1
C
OSTEOPOROSIS
OVERDOSE
1
C
OSTEOPOROSIS
PNEUMONIA
1
C
OSTEOPOROSIS
POLYURIA
1
C
OSTEOPOROSIS
WEIGHT INCREASED
1
C
PRODUCT USED FOR UNKNOWN INDICATION
FATIGUE
1
C
PRODUCT USED FOR UNKNOWN INDICATION
FLUSHING
1
C
PRODUCT USED FOR UNKNOWN INDICATION
HEADACHE
1
C
RHEUMATOID ARTHRITIS
DIABETES MELLITUS
1
C
RHEUMATOID ARTHRITIS
DYSPNOEA
2
C
RHEUMATOID ARTHRITIS
KNEE OPERATION
2
C
SYSTEMIC LUPUS ERYTHEMATOSUS
MATERNAL EXPOSURE DURING PREGNANCY
1
C
SYSTEMIC LUPUS ERYTHEMATOSUS
UTERINE SPASM
1
C
SYSTEMIC LUPUS ERYTHEMATOSUS
VAGINAL HAEMORRHAGE
1
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