Drug information for SPORANOX

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL 100MG Prescription AB (Reference Drug) ITRACONAZOLE Itraconazole JANSSEN PHARMS 20083
2012-04-23 Letter
2012-04-23 Letter
2012-04-23 Letter
2012-04-20 Label
2012-04-20 Label
2012-04-20 Label
2010-08-03 Letter
2010-07-31 Label
2009-03-17 Label
2009-03-17 Label
2009-03-17 Label
2009-03-10 Letter
2009-03-10 Letter
2009-03-10 Letter
2004-07-21 Label
2004-07-21 Letter
2004-07-21 Letter
2004-07-21 Letter
2004-07-21 Label
2003-12-02 Label
2003-11-25 Letter
2003-04-24 Label
2002-07-17 Letter
2002-07-17 Label
2002-07-17 Label
2002-07-17 Letter
2002-04-11 Letter
2002-04-11 Label
CAPSULE; ORAL 100MG Prescription   ITRACONAZOLE Itraconazole JANSSEN PHARMA 20694
2010-01-05 Review
INJECTABLE; INJECTION 10MG/ML Discontinued   ITRACONAZOLE Itraconazole JANSSEN PHARMS 20966
2009-04-28 Label
2009-04-27 Letter
2009-04-03 Label
2009-04-03 Label
2009-04-03 Label
2009-03-10 Letter
2009-03-10 Letter
2009-03-10 Letter
2004-07-21 Label
2004-07-21 Letter
2003-08-13 Review
2002-07-17 Label
2002-07-17 Letter
2002-02-28 Letter
2001-10-26 Review
2001-10-26 Review
2001-10-26 Review
2001-04-17 Letter
2001-04-17 Label
2001-04-17 Letter
2001-04-17 Label
2001-04-17 Letter
2001-04-17 Label
1999-03-30 Letter
1999-03-30 Label
SOLUTION; ORAL 10MG/ML Prescription  (Reference Drug) ITRACONAZOLE Itraconazole JANSSEN PHARMS 20657
2012-03-27 Letter
2012-03-27 Label
2012-03-27 Label
2012-03-27 Letter
2011-04-19 Letter
2011-04-18 Label
2011-01-11 Label
2011-01-07 Letter
2010-08-03 Letter
2010-07-31 Label
2009-03-17 Label
2009-03-17 Label
2009-03-17 Label
2009-03-17 Label
2009-03-10 Letter
2009-03-10 Letter
2009-03-10 Letter
2009-03-10 Letter
2003-09-30 Label
2003-09-30 Letter
2002-09-11 Letter
2002-09-11 Label
2002-07-17 Label
2002-07-17 Letter
2001-10-26 Review
2001-10-26 Review
2001-04-17 Label
2001-04-17 Letter
2001-04-17 Label
2001-04-17 Letter

Drug Adverse Effects information for SPORANOX

Role code Indications Reaction # Reports
PS ARRHYTHMIA NAIL DISORDER 1
PS ARRHYTHMIA OEDEMA PERIPHERAL 1
PS ARRHYTHMIA TOOTH DISORDER 1
PS ASTHMA NAIL DISORDER 1
PS ASTHMA OEDEMA PERIPHERAL 1
PS ASTHMA TOOTH DISORDER 1
PS BRONCHOPULMONARY ASPERGILLOSIS ALLERGIC NAIL DISORDER 1
PS BRONCHOPULMONARY ASPERGILLOSIS ALLERGIC OEDEMA PERIPHERAL 1
PS BRONCHOPULMONARY ASPERGILLOSIS ALLERGIC TOOTH DISORDER 1
PS CANDIDIASIS DEPRESSION 1
PS CANDIDIASIS NIGHTMARE 1
PS DIABETES MELLITUS CARDIAC FAILURE CONGESTIVE 6
PS DIABETES MELLITUS DIABETES MELLITUS 6
PS FUNGAL INFECTION ERYTHEMA 1
PS FUNGAL INFECTION EXTRAVASATION 1
PS FUNGAL INFECTION OEDEMA PERIPHERAL 1
PS HISTOPLASMOSIS CARDIAC FAILURE CONGESTIVE 1
PS HISTOPLASMOSIS DIABETES MELLITUS 1
PS HISTOPLASMOSIS DIARRHOEA 1
PS HISTOPLASMOSIS FATIGUE 1
PS HISTOPLASMOSIS NAUSEA 1
PS HISTOPLASMOSIS PULMONARY OEDEMA 1
PS HISTOPLASMOSIS WEIGHT DECREASED 1
PS HISTOPLASMOSIS DISSEMINATED CARDIAC FAILURE CONGESTIVE 2
PS HISTOPLASMOSIS DISSEMINATED DIABETES MELLITUS 2
PS HYPERTENSION CARDIAC FAILURE CONGESTIVE 3
PS HYPERTENSION DIABETES MELLITUS 3
PS HYPERTENSION NAIL DISORDER 1
PS HYPERTENSION OEDEMA PERIPHERAL 1
PS HYPERTENSION TOOTH DISORDER 1
PS ILL-DEFINED DISORDER CONFUSIONAL STATE 1
PS ILL-DEFINED DISORDER DRUG INTERACTION 1
PS INSOMNIA CONFUSIONAL STATE 1
PS INSOMNIA DRUG INTERACTION 1
PS MYCOTIC ALLERGY INCORRECT DOSE ADMINISTERED 1
PS MYCOTIC ALLERGY MYOCARDIAL INFARCTION 1
PS MYCOTIC ALLERGY OFF LABEL USE 1
PS MYELODYSPLASTIC SYNDROME CARDIAC FAILURE ACUTE 1
PS ONYCHOMYCOSIS ASTHENIA 1
PS ONYCHOMYCOSIS DYSAESTHESIA 1
PS ONYCHOMYCOSIS HEADACHE 1
PS ONYCHOMYCOSIS MOBILITY DECREASED 1
PS ONYCHOMYCOSIS PAIN 1
PS PNEUMONIA CONDITION AGGRAVATED 2
PS PNEUMONIA RED BLOOD CELL COUNT DECREASED 2
PS PNEUMONIA THROMBOCYTOPENIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION CONFUSIONAL STATE 1
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG INTERACTION 1
PS PULMONARY MYCOSIS CARDIAC FAILURE ACUTE 1
PS SPUTUM INCREASED INCORRECT DOSE ADMINISTERED 1
PS SPUTUM INCREASED MYOCARDIAL INFARCTION 1
PS SPUTUM INCREASED OFF LABEL USE 1
PS SYSTEMIC MYCOSIS CONDITION AGGRAVATED 1
PS SYSTEMIC MYCOSIS RED BLOOD CELL COUNT DECREASED 1
PS SYSTEMIC MYCOSIS THROMBOCYTOPENIA 1
PS VAGINAL DISCHARGE HAEMORRHAGE 1
PS VAGINAL DISCHARGE RASH 1
SS CANDIDIASIS DEPRESSION 1
SS CANDIDIASIS NIGHTMARE 1
SS DIABETES MELLITUS CARDIAC FAILURE CONGESTIVE 4
SS DIABETES MELLITUS DIABETES MELLITUS 4
SS HISTOPLASMOSIS DISSEMINATED CARDIAC FAILURE CONGESTIVE 2
SS HISTOPLASMOSIS DISSEMINATED DIABETES MELLITUS 2
SS HYPERTENSION CARDIAC FAILURE CONGESTIVE 2
SS HYPERTENSION DIABETES MELLITUS 2
SS MYCOTIC ALLERGY INCORRECT DOSE ADMINISTERED 1
SS MYCOTIC ALLERGY MYOCARDIAL INFARCTION 1
SS MYCOTIC ALLERGY OFF LABEL USE 1
SS MYELODYSPLASTIC SYNDROME CARDIAC FAILURE ACUTE 1
SS PNEUMONIA CONDITION AGGRAVATED 2
SS PNEUMONIA RED BLOOD CELL COUNT DECREASED 2
SS PNEUMONIA THROMBOCYTOPENIA 2
SS PULMONARY MYCOSIS CARDIAC FAILURE ACUTE 1
SS SPUTUM INCREASED INCORRECT DOSE ADMINISTERED 1
SS SPUTUM INCREASED MYOCARDIAL INFARCTION 1
SS SPUTUM INCREASED OFF LABEL USE 1
SS SYSTEMIC MYCOSIS CONDITION AGGRAVATED 1
SS SYSTEMIC MYCOSIS RED BLOOD CELL COUNT DECREASED 1
SS SYSTEMIC MYCOSIS THROMBOCYTOPENIA 1
C ABNORMAL BEHAVIOUR ALANINE AMINOTRANSFERASE INCREASED 2
C ABNORMAL BEHAVIOUR ASPARTATE AMINOTRANSFERASE INCREASED 2
C ABNORMAL BEHAVIOUR CYTOLYTIC HEPATITIS 2
C ABNORMAL BEHAVIOUR HEPATOMEGALY 2
C ABNORMAL BEHAVIOUR HYPOKALAEMIA 1
C ACUTE MYELOID LEUKAEMIA ACTINIC KERATOSIS 2
C ACUTE MYELOID LEUKAEMIA ATELECTASIS 2
C ACUTE MYELOID LEUKAEMIA BLOOD ALKALINE PHOSPHATASE INCREASED 2
C ACUTE MYELOID LEUKAEMIA BONE MARROW FAILURE 2
C ACUTE MYELOID LEUKAEMIA CLOSTRIDIUM DIFFICILE COLITIS 2
C ACUTE MYELOID LEUKAEMIA DIARRHOEA 2
C ACUTE MYELOID LEUKAEMIA DYSPHAGIA 2
C ACUTE MYELOID LEUKAEMIA ENTEROCOCCAL BACTERAEMIA 2
C ACUTE MYELOID LEUKAEMIA FAECAL INCONTINENCE 2
C ACUTE MYELOID LEUKAEMIA FALL 2
C ACUTE MYELOID LEUKAEMIA FUNGAL INFECTION 2
C ACUTE MYELOID LEUKAEMIA HAEMATEMESIS 2
C ACUTE MYELOID LEUKAEMIA HERPES DERMATITIS 2
C ACUTE MYELOID LEUKAEMIA HYPOTENSION 2
C ACUTE MYELOID LEUKAEMIA KERATITIS HERPETIC 2
C ACUTE MYELOID LEUKAEMIA LOBAR PNEUMONIA 2
C ACUTE MYELOID LEUKAEMIA MUSCULAR WEAKNESS 2
C ACUTE MYELOID LEUKAEMIA ORTHOSTATIC INTOLERANCE 2
C ACUTE MYELOID LEUKAEMIA PARANASAL CYST 2
C ACUTE MYELOID LEUKAEMIA PERIPHERAL SENSORIMOTOR NEUROPATHY 2
C ACUTE MYELOID LEUKAEMIA PLEURAL EFFUSION 2
C ACUTE MYELOID LEUKAEMIA PRESYNCOPE 2
C ACUTE MYELOID LEUKAEMIA PSEUDOMONAS TEST POSITIVE 2
C ACUTE MYELOID LEUKAEMIA PULMONARY OEDEMA 2
C ACUTE MYELOID LEUKAEMIA PURPURA 2
C ACUTE MYELOID LEUKAEMIA RASH 2
C ACUTE MYELOID LEUKAEMIA SINUS POLYP 2
C ACUTE MYELOID LEUKAEMIA SKIN EXFOLIATION 2
C ACUTE MYELOID LEUKAEMIA SPLENIC INFARCTION 2
C ACUTE MYELOID LEUKAEMIA SQUAMOUS CELL CARCINOMA OF SKIN 2
C ACUTE MYELOID LEUKAEMIA STAPHYLOCOCCUS TEST POSITIVE 2
C ACUTE MYELOID LEUKAEMIA TOXICITY TO VARIOUS AGENTS 2
C ACUTE MYELOID LEUKAEMIA URINARY INCONTINENCE 2
C ACUTE MYELOID LEUKAEMIA URINARY TRACT INFECTION ENTEROCOCCAL 2
C ANGINA PECTORIS AGITATION 1
C ANGINA PECTORIS ANXIETY 1
C ANGINA PECTORIS DELUSIONAL DISORDER, UNSPECIFIED TYPE 1
C ANGINA PECTORIS HALLUCINATION 1
C ANXIETY AGITATION 1
C ANXIETY ANXIETY 1
C ANXIETY DELUSIONAL DISORDER, UNSPECIFIED TYPE 1
C ANXIETY HALLUCINATION 1
C ASPERGILLOSIS ALANINE AMINOTRANSFERASE INCREASED 2
C ASPERGILLOSIS ASPARTATE AMINOTRANSFERASE INCREASED 2
C ASPERGILLOSIS CYTOLYTIC HEPATITIS 2
C ASPERGILLOSIS HEPATOMEGALY 2
C ASPERGILLOSIS HYPOKALAEMIA 2
C ASPERGILLUS TEST POSITIVE ALANINE AMINOTRANSFERASE INCREASED 4
C ASPERGILLUS TEST POSITIVE ASPARTATE AMINOTRANSFERASE INCREASED 4
C ASPERGILLUS TEST POSITIVE CYTOLYTIC HEPATITIS 4
C ASPERGILLUS TEST POSITIVE HEPATOMEGALY 4
C ASPERGILLUS TEST POSITIVE HYPOKALAEMIA 2
C ASTHMA AGITATION 2
C ASTHMA ANXIETY 2
C ASTHMA COUGH 1
C ASTHMA DELUSIONAL DISORDER, UNSPECIFIED TYPE 2
C ASTHMA DRUG INEFFECTIVE 1
C ASTHMA HALLUCINATION 2
C ASTHMA INFLUENZA 1
C ASTHMA LUNG INFECTION 1
C ASTHMA NASAL CONGESTION 1
C ASTHMA RHINORRHOEA 1
C BACK PAIN AGITATION 1
C BACK PAIN ANXIETY 1
C BACK PAIN DELUSIONAL DISORDER, UNSPECIFIED TYPE 1
C BACK PAIN HALLUCINATION 1
C HYPERTENSION AGITATION 1
C HYPERTENSION ANXIETY 1
C HYPERTENSION DELUSIONAL DISORDER, UNSPECIFIED TYPE 1
C HYPERTENSION HALLUCINATION 1
C NAUSEA ALANINE AMINOTRANSFERASE INCREASED 2
C NAUSEA ASPARTATE AMINOTRANSFERASE INCREASED 2
C NAUSEA CYTOLYTIC HEPATITIS 2
C NAUSEA HEPATOMEGALY 2
C NAUSEA HYPOKALAEMIA 1
C NON-HODGKIN'S LYMPHOMA FUNGAL INFECTION 2
C NON-HODGKIN'S LYMPHOMA RESPIRATORY FAILURE 2
C OSTEOPENIA ANAEMIA 1
C OSTEOPENIA ANHEDONIA 1
C OSTEOPENIA ANXIETY 1
C OSTEOPENIA ARTHRALGIA 1
C OSTEOPENIA CARPAL TUNNEL SYNDROME 1
C OSTEOPENIA CATARACT 1
C OSTEOPENIA CERVICOBRACHIAL SYNDROME 1
C OSTEOPENIA CHEST PAIN 1
C OSTEOPENIA DYSLIPIDAEMIA 1
C OSTEOPENIA DYSPLASIA 1
C OSTEOPENIA FISTULA 1
C OSTEOPENIA HAEMORRHOIDS 1
C OSTEOPENIA HOT FLUSH 1
C OSTEOPENIA HYPOAESTHESIA 1
C OSTEOPENIA HYPOPHOSPHATASIA 1
C OSTEOPENIA HYPOTHYROIDISM 1
C OSTEOPENIA IMPAIRED HEALING 1
C OSTEOPENIA IMPLANT SITE SWELLING 1
C OSTEOPENIA INJURY 1
C OSTEOPENIA INTERVERTEBRAL DISC PROTRUSION 1
C OSTEOPENIA LIBIDO DECREASED 1
C OSTEOPENIA MONOCLONAL GAMMOPATHY 1
C OSTEOPENIA MULTIPLE MYELOMA 1
C OSTEOPENIA MUSCLE SPASMS 1
C OSTEOPENIA MUSCLE STRAIN 1
C OSTEOPENIA NECK PAIN 1
C OSTEOPENIA OSTEONECROSIS OF JAW 1
C OSTEOPENIA OSTEOPENIA 1
C OSTEOPENIA OSTEOSCLEROSIS 1
C OSTEOPENIA PAIN 1
C OSTEOPENIA PAIN IN EXTREMITY 1
C OSTEOPENIA PALPITATIONS 1
C OSTEOPENIA PARAESTHESIA 1
C OSTEOPENIA PARAPROTEINAEMIA 1
C OSTEOPENIA PRIMARY SEQUESTRUM 1
C OSTEOPENIA RETINAL DEGENERATION 1
C OSTEOPENIA RETINAL TEAR 1
C OSTEOPENIA RHINORRHOEA 1
C OSTEOPENIA TOOTH LOSS 1
C OSTEOPOROSIS ANAEMIA 1
C OSTEOPOROSIS ANHEDONIA 1
C OSTEOPOROSIS ANXIETY 1
C OSTEOPOROSIS ARTHRALGIA 1
C OSTEOPOROSIS CARPAL TUNNEL SYNDROME 1
C OSTEOPOROSIS CATARACT 1
C OSTEOPOROSIS CERVICOBRACHIAL SYNDROME 1
C OSTEOPOROSIS CHEST PAIN 1
C OSTEOPOROSIS DYSLIPIDAEMIA 1
C OSTEOPOROSIS DYSPLASIA 1
C OSTEOPOROSIS FISTULA 1
C OSTEOPOROSIS HAEMORRHOIDS 1
C OSTEOPOROSIS HOT FLUSH 1
C OSTEOPOROSIS HYPOAESTHESIA 1
C OSTEOPOROSIS HYPOPHOSPHATASIA 1
C OSTEOPOROSIS HYPOTHYROIDISM 1
C OSTEOPOROSIS IMPAIRED HEALING 1
C OSTEOPOROSIS IMPLANT SITE SWELLING 1
C OSTEOPOROSIS INJURY 1
C OSTEOPOROSIS INTERVERTEBRAL DISC PROTRUSION 1
C OSTEOPOROSIS LIBIDO DECREASED 1
C OSTEOPOROSIS MONOCLONAL GAMMOPATHY 1
C OSTEOPOROSIS MULTIPLE MYELOMA 1
C OSTEOPOROSIS MUSCLE SPASMS 1
C OSTEOPOROSIS MUSCLE STRAIN 1
C OSTEOPOROSIS NECK PAIN 1
C OSTEOPOROSIS OSTEONECROSIS OF JAW 1
C OSTEOPOROSIS OSTEOPENIA 1
C OSTEOPOROSIS OSTEOSCLEROSIS 1
C OSTEOPOROSIS PAIN 1
C OSTEOPOROSIS PAIN IN EXTREMITY 1
C OSTEOPOROSIS PALPITATIONS 1
C OSTEOPOROSIS PARAESTHESIA 1
C OSTEOPOROSIS PARAPROTEINAEMIA 1
C OSTEOPOROSIS PRIMARY SEQUESTRUM 1
C OSTEOPOROSIS RETINAL DEGENERATION 1
C OSTEOPOROSIS RETINAL TEAR 1
C OSTEOPOROSIS RHINORRHOEA 1
C OSTEOPOROSIS TOOTH LOSS 1
C PAIN AGITATION 2
C PAIN ALANINE AMINOTRANSFERASE INCREASED 8
C PAIN ANXIETY 2
C PAIN ASPARTATE AMINOTRANSFERASE INCREASED 8
C PAIN CYTOLYTIC HEPATITIS 8
C PAIN DELUSIONAL DISORDER, UNSPECIFIED TYPE 2
C PAIN HALLUCINATION 2
C PAIN HEPATOMEGALY 8
C PAIN HYPOKALAEMIA 4
C PALLIATIVE CARE AGITATION 1
C PALLIATIVE CARE ANXIETY 1
C PALLIATIVE CARE DELUSIONAL DISORDER, UNSPECIFIED TYPE 1
C PALLIATIVE CARE HALLUCINATION 1
C PRODUCT USED FOR UNKNOWN INDICATION AGITATION 1
C PRODUCT USED FOR UNKNOWN INDICATION ALANINE AMINOTRANSFERASE INCREASED 22
C PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 1
C PRODUCT USED FOR UNKNOWN INDICATION ASPARTATE AMINOTRANSFERASE INCREASED 22
C PRODUCT USED FOR UNKNOWN INDICATION COUGH 4
C PRODUCT USED FOR UNKNOWN INDICATION CYTOLYTIC HEPATITIS 22
C PRODUCT USED FOR UNKNOWN INDICATION DELUSIONAL DISORDER, UNSPECIFIED TYPE 1
C PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 4
C PRODUCT USED FOR UNKNOWN INDICATION HALLUCINATION 1
C PRODUCT USED FOR UNKNOWN INDICATION HEPATOMEGALY 22
C PRODUCT USED FOR UNKNOWN INDICATION HYPOKALAEMIA 22
C PRODUCT USED FOR UNKNOWN INDICATION INFLUENZA 4
C PRODUCT USED FOR UNKNOWN INDICATION LUNG INFECTION 4
C PRODUCT USED FOR UNKNOWN INDICATION NASAL CONGESTION 4
C PRODUCT USED FOR UNKNOWN INDICATION RHINORRHOEA 4
C PULMONARY ARTERIAL HYPERTENSION DIARRHOEA 1
C PULMONARY ARTERIAL HYPERTENSION FACE OEDEMA 1
C PULMONARY ARTERIAL HYPERTENSION OEDEMA PERIPHERAL 1
C THROMBOSIS PROPHYLAXIS ALANINE AMINOTRANSFERASE INCREASED 2
C THROMBOSIS PROPHYLAXIS ASPARTATE AMINOTRANSFERASE INCREASED 2
C THROMBOSIS PROPHYLAXIS CYTOLYTIC HEPATITIS 2
C THROMBOSIS PROPHYLAXIS HEPATOMEGALY 2
C THROMBOSIS PROPHYLAXIS HYPOKALAEMIA 1
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