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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