Drug information for STROMECTOL
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
3MG
Prescription
(Reference Drug)
IVERMECTIN
Ivermectin
MERCK
50742
2009-12-24 Letter
2009-12-16 Label
2009-06-22 Label
2009-06-22 Label
2009-06-17 Letter
2009-06-17 Letter
2009-05-11 Label
2008-09-16 Label
2008-09-16 Letter
2008-02-27 Letter
2007-10-04 Letter
2007-10-04 Letter
2007-09-26 Label
2007-09-26 Label
2006-01-30 Letter
2006-01-30 Letter
2006-01-27 Label
2006-01-27 Label
2005-03-08 Review
2004-12-02 Label
2004-03-03 Label
2004-03-03 Label
2004-02-27 Letter
2004-02-27 Letter
2003-01-15 Label
2003-01-15 Letter
1997-11-26 Review
TABLET; ORAL
6MG
Discontinued
IVERMECTIN
Ivermectin
MERCK
"
Drug Adverse Effects information for STROMECTOL
Role code
Indications
Reaction
# Reports
PS
ACARODERMATITIS
ALANINE AMINOTRANSFERASE INCREASED
4
PS
ACARODERMATITIS
ASPARTATE AMINOTRANSFERASE INCREASED
4
PS
ACARODERMATITIS
BLOOD ALKALINE PHOSPHATASE INCREASED
4
PS
ACARODERMATITIS
BLOOD BILIRUBIN INCREASED
4
PS
ACARODERMATITIS
CONFUSIONAL STATE
1
PS
ACARODERMATITIS
CONVULSION
1
PS
ACARODERMATITIS
GASTROOESOPHAGEAL REFLUX DISEASE
4
PS
ACARODERMATITIS
LIVER DISORDER
4
PS
ACARODERMATITIS
PLATELET COUNT DECREASED
1
PS
FILARIASIS LYMPHATIC
ABNORMAL BEHAVIOUR
2
PS
FILARIASIS LYMPHATIC
ASTHENIA
8
PS
FILARIASIS LYMPHATIC
BACK PAIN
4
PS
FILARIASIS LYMPHATIC
BLOOD GLUCOSE INCREASED
2
PS
FILARIASIS LYMPHATIC
CHILLS
4
PS
FILARIASIS LYMPHATIC
COMA
2
PS
FILARIASIS LYMPHATIC
CONJUNCTIVAL HAEMORRHAGE
2
PS
FILARIASIS LYMPHATIC
DECUBITUS ULCER
2
PS
FILARIASIS LYMPHATIC
DEPRESSED LEVEL OF CONSCIOUSNESS
2
PS
FILARIASIS LYMPHATIC
DIARRHOEA
4
PS
FILARIASIS LYMPHATIC
DRUG INTERACTION
2
PS
FILARIASIS LYMPHATIC
DYSARTHRIA
4
PS
FILARIASIS LYMPHATIC
ENCEPHALOPATHY
4
PS
FILARIASIS LYMPHATIC
GAIT DISTURBANCE
4
PS
FILARIASIS LYMPHATIC
HICCUPS
2
PS
FILARIASIS LYMPHATIC
NERVOUS SYSTEM DISORDER
4
PS
FILARIASIS LYMPHATIC
OCULAR HYPERAEMIA
4
PS
FILARIASIS LYMPHATIC
PYREXIA
4
PS
FILARIASIS LYMPHATIC
SOMNOLENCE
2
PS
FILARIASIS LYMPHATIC
URINARY INCONTINENCE
2
PS
FILARIASIS LYMPHATIC
VERTIGO
2
PS
ONCHOCERCIASIS
ABDOMINAL PAIN UPPER
1
PS
ONCHOCERCIASIS
ABNORMAL BEHAVIOUR
2
PS
ONCHOCERCIASIS
ASTHENIA
7
PS
ONCHOCERCIASIS
BACK PAIN
4
PS
ONCHOCERCIASIS
BLOOD GLUCOSE INCREASED
2
PS
ONCHOCERCIASIS
CEREBRAL ARTERY EMBOLISM
2
PS
ONCHOCERCIASIS
CHILLS
4
PS
ONCHOCERCIASIS
CONJUNCTIVAL HAEMORRHAGE
3
PS
ONCHOCERCIASIS
DEPRESSED LEVEL OF CONSCIOUSNESS
1
PS
ONCHOCERCIASIS
DIARRHOEA
3
PS
ONCHOCERCIASIS
DRUG INTERACTION
2
PS
ONCHOCERCIASIS
DYSARTHRIA
4
PS
ONCHOCERCIASIS
ENCEPHALOPATHY
2
PS
ONCHOCERCIASIS
GAIT DISTURBANCE
4
PS
ONCHOCERCIASIS
HEADACHE
1
PS
ONCHOCERCIASIS
HICCUPS
2
PS
ONCHOCERCIASIS
NERVOUS SYSTEM DISORDER
6
PS
ONCHOCERCIASIS
OCULAR HYPERAEMIA
4
PS
ONCHOCERCIASIS
PYREXIA
3
PS
ONCHOCERCIASIS
SOMNOLENCE
2
PS
ONCHOCERCIASIS
URINARY INCONTINENCE
2
PS
ONCHOCERCIASIS
VERTIGO
2
PS
PRURITUS
ALANINE AMINOTRANSFERASE INCREASED
2
PS
PRURITUS
ASPARTATE AMINOTRANSFERASE INCREASED
2
PS
PRURITUS
BLOOD ALKALINE PHOSPHATASE INCREASED
2
PS
PRURITUS
BLOOD BILIRUBIN INCREASED
2
PS
PRURITUS
GASTROOESOPHAGEAL REFLUX DISEASE
2
PS
PRURITUS
LIVER DISORDER
2
SS
ACARODERMATITIS
ALANINE AMINOTRANSFERASE INCREASED
4
SS
ACARODERMATITIS
ASPARTATE AMINOTRANSFERASE INCREASED
4
SS
ACARODERMATITIS
BLOOD ALKALINE PHOSPHATASE INCREASED
4
SS
ACARODERMATITIS
BLOOD BILIRUBIN INCREASED
4
SS
ACARODERMATITIS
GASTROOESOPHAGEAL REFLUX DISEASE
4
SS
ACARODERMATITIS
LIVER DISORDER
4
SS
ACARODERMATITIS
PLATELET COUNT DECREASED
1
SS
CRYOGLOBULINAEMIA
HEPATITIS
2
SS
FILARIASIS LYMPHATIC
ABNORMAL BEHAVIOUR
2
SS
FILARIASIS LYMPHATIC
ASTHENIA
6
SS
FILARIASIS LYMPHATIC
BACK PAIN
4
SS
FILARIASIS LYMPHATIC
BLOOD GLUCOSE INCREASED
2
SS
FILARIASIS LYMPHATIC
CHILLS
4
SS
FILARIASIS LYMPHATIC
CONJUNCTIVAL HAEMORRHAGE
2
SS
FILARIASIS LYMPHATIC
DIARRHOEA
2
SS
FILARIASIS LYMPHATIC
DRUG INTERACTION
2
SS
FILARIASIS LYMPHATIC
DYSARTHRIA
4
SS
FILARIASIS LYMPHATIC
ENCEPHALOPATHY
2
SS
FILARIASIS LYMPHATIC
GAIT DISTURBANCE
4
SS
FILARIASIS LYMPHATIC
HICCUPS
2
SS
FILARIASIS LYMPHATIC
NERVOUS SYSTEM DISORDER
4
SS
FILARIASIS LYMPHATIC
OCULAR HYPERAEMIA
4
SS
FILARIASIS LYMPHATIC
PYREXIA
2
SS
FILARIASIS LYMPHATIC
SOMNOLENCE
2
SS
FILARIASIS LYMPHATIC
URINARY INCONTINENCE
2
SS
FILARIASIS LYMPHATIC
VERTIGO
2
SS
ONCHOCERCIASIS
ABNORMAL BEHAVIOUR
2
SS
ONCHOCERCIASIS
ASTHENIA
6
SS
ONCHOCERCIASIS
BACK PAIN
4
SS
ONCHOCERCIASIS
BLOOD GLUCOSE INCREASED
2
SS
ONCHOCERCIASIS
CHILLS
4
SS
ONCHOCERCIASIS
CONJUNCTIVAL HAEMORRHAGE
2
SS
ONCHOCERCIASIS
DIARRHOEA
2
SS
ONCHOCERCIASIS
DRUG INTERACTION
2
SS
ONCHOCERCIASIS
DYSARTHRIA
4
SS
ONCHOCERCIASIS
ENCEPHALOPATHY
2
SS
ONCHOCERCIASIS
GAIT DISTURBANCE
4
SS
ONCHOCERCIASIS
HICCUPS
2
SS
ONCHOCERCIASIS
NERVOUS SYSTEM DISORDER
4
SS
ONCHOCERCIASIS
OCULAR HYPERAEMIA
4
SS
ONCHOCERCIASIS
PYREXIA
2
SS
ONCHOCERCIASIS
SOMNOLENCE
2
SS
ONCHOCERCIASIS
URINARY INCONTINENCE
2
SS
ONCHOCERCIASIS
VERTIGO
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
HEPATITIS
1
SS
PRURITUS
ALANINE AMINOTRANSFERASE INCREASED
2
SS
PRURITUS
ASPARTATE AMINOTRANSFERASE INCREASED
2
SS
PRURITUS
BLOOD ALKALINE PHOSPHATASE INCREASED
2
SS
PRURITUS
BLOOD BILIRUBIN INCREASED
2
SS
PRURITUS
GASTROOESOPHAGEAL REFLUX DISEASE
2
SS
PRURITUS
LIVER DISORDER
2
C
BRONCHITIS
ANAEMIA
1
C
BRONCHITIS
ASCITES
1
C
BRONCHITIS
ASTHENIA
1
C
BRONCHITIS
BACTERIAL SEPSIS
1
C
BRONCHITIS
CANDIDIASIS
1
C
BRONCHITIS
CHOLESTASIS
1
C
BRONCHITIS
COUGH
1
C
BRONCHITIS
CYTOLYTIC HEPATITIS
1
C
BRONCHITIS
CYTOMEGALOVIRUS INFECTION
1
C
BRONCHITIS
DERMATITIS ALLERGIC
1
C
BRONCHITIS
EOSINOPHILIA
1
C
BRONCHITIS
FASCIOLIASIS
1
C
BRONCHITIS
HAEMOLYTIC ANAEMIA
1
C
BRONCHITIS
HEPATIC ENCEPHALOPATHY
1
C
BRONCHITIS
HEPATIC FAILURE
1
C
BRONCHITIS
INFECTIOUS PERITONITIS
1
C
BRONCHITIS
LUNG DISORDER
1
C
BRONCHITIS
MALNUTRITION
1
C
BRONCHITIS
MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE
1
C
BRONCHITIS
NIGHT SWEATS
1
C
BRONCHITIS
PRURITUS
1
C
BRONCHITIS
PRURITUS ALLERGIC
1
C
BRONCHITIS
PSYCHOMOTOR RETARDATION
1
C
BRONCHITIS
PYREXIA
1
C
BRONCHITIS
THROMBOCYTOPENIA
1
C
BRONCHITIS
VOMITING
1
C
BRONCHITIS
WEIGHT DECREASED
1
C
COUGH
ANAEMIA
1
C
COUGH
ASCITES
1
C
COUGH
ASTHENIA
1
C
COUGH
BACTERIAL SEPSIS
1
C
COUGH
CANDIDIASIS
1
C
COUGH
CHOLESTASIS
1
C
COUGH
COUGH
1
C
COUGH
CYTOLYTIC HEPATITIS
1
C
COUGH
CYTOMEGALOVIRUS INFECTION
1
C
COUGH
DERMATITIS ALLERGIC
1
C
COUGH
EOSINOPHILIA
1
C
COUGH
FASCIOLIASIS
1
C
COUGH
HAEMOLYTIC ANAEMIA
1
C
COUGH
HEPATIC ENCEPHALOPATHY
1
C
COUGH
HEPATIC FAILURE
1
C
COUGH
INFECTIOUS PERITONITIS
1
C
COUGH
LUNG DISORDER
1
C
COUGH
MALNUTRITION
1
C
COUGH
MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE
1
C
COUGH
NIGHT SWEATS
1
C
COUGH
PRURITUS
1
C
COUGH
PRURITUS ALLERGIC
1
C
COUGH
PSYCHOMOTOR RETARDATION
1
C
COUGH
PYREXIA
1
C
COUGH
THROMBOCYTOPENIA
1
C
COUGH
VOMITING
1
C
COUGH
WEIGHT DECREASED
1
C
GASTROINTESTINAL DISORDER
ANAEMIA
1
C
GASTROINTESTINAL DISORDER
ASCITES
1
C
GASTROINTESTINAL DISORDER
ASTHENIA
1
C
GASTROINTESTINAL DISORDER
BACTERIAL SEPSIS
1
C
GASTROINTESTINAL DISORDER
CANDIDIASIS
1
C
GASTROINTESTINAL DISORDER
CHOLESTASIS
1
C
GASTROINTESTINAL DISORDER
COUGH
1
C
GASTROINTESTINAL DISORDER
CYTOLYTIC HEPATITIS
1
C
GASTROINTESTINAL DISORDER
CYTOMEGALOVIRUS INFECTION
1
C
GASTROINTESTINAL DISORDER
DERMATITIS ALLERGIC
1
C
GASTROINTESTINAL DISORDER
EOSINOPHILIA
1
C
GASTROINTESTINAL DISORDER
FASCIOLIASIS
1
C
GASTROINTESTINAL DISORDER
HAEMOLYTIC ANAEMIA
1
C
GASTROINTESTINAL DISORDER
HEPATIC ENCEPHALOPATHY
1
C
GASTROINTESTINAL DISORDER
HEPATIC FAILURE
1
C
GASTROINTESTINAL DISORDER
INFECTIOUS PERITONITIS
1
C
GASTROINTESTINAL DISORDER
LUNG DISORDER
1
C
GASTROINTESTINAL DISORDER
MALNUTRITION
1
C
GASTROINTESTINAL DISORDER
MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE
1
C
GASTROINTESTINAL DISORDER
NIGHT SWEATS
1
C
GASTROINTESTINAL DISORDER
PRURITUS
1
C
GASTROINTESTINAL DISORDER
PRURITUS ALLERGIC
1
C
GASTROINTESTINAL DISORDER
PSYCHOMOTOR RETARDATION
1
C
GASTROINTESTINAL DISORDER
PYREXIA
1
C
GASTROINTESTINAL DISORDER
THROMBOCYTOPENIA
1
C
GASTROINTESTINAL DISORDER
VOMITING
1
C
GASTROINTESTINAL DISORDER
WEIGHT DECREASED
1
C
RHEUMATOID ARTHRITIS
ANAEMIA
2
C
RHEUMATOID ARTHRITIS
ASCITES
2
C
RHEUMATOID ARTHRITIS
ASTHENIA
2
C
RHEUMATOID ARTHRITIS
BACTERIAL SEPSIS
2
C
RHEUMATOID ARTHRITIS
CANDIDIASIS
2
C
RHEUMATOID ARTHRITIS
CHOLESTASIS
2
C
RHEUMATOID ARTHRITIS
COUGH
2
C
RHEUMATOID ARTHRITIS
CYTOLYTIC HEPATITIS
2
C
RHEUMATOID ARTHRITIS
CYTOMEGALOVIRUS INFECTION
2
C
RHEUMATOID ARTHRITIS
DERMATITIS ALLERGIC
2
C
RHEUMATOID ARTHRITIS
EOSINOPHILIA
2
C
RHEUMATOID ARTHRITIS
FASCIOLIASIS
2
C
RHEUMATOID ARTHRITIS
HAEMOLYTIC ANAEMIA
2
C
RHEUMATOID ARTHRITIS
HEPATIC ENCEPHALOPATHY
2
C
RHEUMATOID ARTHRITIS
HEPATIC FAILURE
2
C
RHEUMATOID ARTHRITIS
INFECTIOUS PERITONITIS
2
C
RHEUMATOID ARTHRITIS
LUNG DISORDER
2
C
RHEUMATOID ARTHRITIS
MALNUTRITION
2
C
RHEUMATOID ARTHRITIS
MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE
2
C
RHEUMATOID ARTHRITIS
NIGHT SWEATS
2
C
RHEUMATOID ARTHRITIS
PRURITUS
2
C
RHEUMATOID ARTHRITIS
PRURITUS ALLERGIC
2
C
RHEUMATOID ARTHRITIS
PSYCHOMOTOR RETARDATION
2
C
RHEUMATOID ARTHRITIS
PYREXIA
2
C
RHEUMATOID ARTHRITIS
THROMBOCYTOPENIA
2
C
RHEUMATOID ARTHRITIS
VOMITING
2
C
RHEUMATOID ARTHRITIS
WEIGHT DECREASED
2
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