CLOFAZIMINE Side Effects

6977327-2 | Erythema, Haemolytic Anaemia, Hepatic Enzyme Increased, Lepromatous Leprosy, Pain Of Skin, Skin Lesion
on Aug 24, 2010 Male patient from BRAZIL , 61 years of age, was diagnosed with lepromatous leprosy and was treated with Clofazimine (View Usage). Patient experienced the following unwanted or unexpected effects: erythema, haemolytic anaemia, hepatic enzyme increased, lepromatous leprosy, pain of skin, skin lesion. Clofazimine dosage: 300 Mg. During the same period patient was treated with DAPSONE (100 Mg/day) (View Dapsone Review and Dapsone Label ), RIFAMPICIN (600 Mg, Unk) (View Rifampicin Review and Rifampicin Label ), TACROLIMUS (6 Mg/day) (View Tacrolimus Review and Tacrolimus Label ), MYCOPHENOLATE MOFETIL (2 G/day) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), PREDNISONE (0.5 Mg/kg/day) (View Prednisone Review and Prednisone Label ), NSAID'S (View Nsaid's Review and Nsaid's Label ).

6906936-1 | Abdominal Pain Lower, Abdominal Pain Upper, Agranulocytosis, Blood Fibrinogen Increased, Bone Marrow Failure, Cardiac Murmur, Chills, Dehydration, Dysphagia
Patient was taking Clofazimine (View Usage). Patient had the following side effects: abdominal pain lower, abdominal pain upper, agranulocytosis, blood fibrinogen increased, bone marrow failure, cardiac murmur, chills, dehydration, dysphagia on May 19, 2010 from BRAZIL Additional patient health information: Female patient , 28 years of age, was diagnosed with leprosy and. Clofazimine dosage: . During the same period patient was treated with RIFAMPICIN (View Rifampicin Review and Rifampicin Label ), DAPSONE (View Dapsone Review and Dapsone Label ), BENZATHINE BENZYLPENICILLIN (View Benzathine Benzylpenicillin Review and Benzathine Benzylpenicillin Label ), I.V. SOLUTIONS (View I.v. Solutions Review and I.v. Solutions Label ). Patient was hospitalized.

6879025-2 | Abdominal Pain Lower, Abdominal Pain Upper, Agranulocytosis, Blood Fibrinogen Increased, Bone Marrow Failure, Cardiac Murmur, Chills, Dehydration, Dysphagia
Adverse event was reported on May 19, 2010 by a Female patient taking Clofazimine (View Usage) (Dosage: ) was diagnosed with leprosy and. Location: BRAZIL , 28 years of age, After Clofazimine was administered, patient had the following side effects: abdominal pain lower, abdominal pain upper, agranulocytosis, blood fibrinogen increased, bone marrow failure, cardiac murmur, chills, dehydration, dysphagia. During the same period patient was treated with RIFAMPICIN (View Rifampicin Review and Rifampicin Label ), DAPSONE (View Dapsone Review and Dapsone Label ), BENZATHINE BENZYLPENICILLIN (View Benzathine Benzylpenicillin Review and Benzathine Benzylpenicillin Label ), I.V. SOLUTIONS (View I.v. Solutions Review and I.v. Solutions Label ). Patient was hospitalized.

6866732-0 | Arthralgia, Fatigue, Haemorrhage, Joint Swelling, Nodule, Pain, Type 2 Lepra Reaction
on Jul 08, 2010 Female patient from GERMANY , 33 years of age, was diagnosed with leprosy and was treated with Clofazimine (View Usage). Patient experienced the following unwanted or unexpected effects: arthralgia, fatigue, haemorrhage, joint swelling, nodule, pain (What is pain?), type 2 lepra reaction. Clofazimine dosage: . During the same period patient was treated with RIFAMPICIN (View Rifampicin Review and Rifampicin Label ), DAPSONE (View Dapsone Review and Dapsone Label ).


6761303-9 | Dermatitis, Granuloma, Neuropathy Peripheral, Pain In Extremity, Tuberculoid Leprosy, Type Iv Hypersensitivity Reaction
on Feb 12, 2009 Female patient from AUSTRALIA , 84 years of age, was diagnosed with leprosy and was treated with Clofazimine (View Usage). Patient had the following side effects: dermatitis, granuloma, neuropathy peripheral, pain in extremity, tuberculoid leprosy, type iv hypersensitivity reaction. Clofazimine dosage: 50 Mg/day. During the same period patient was treated with RIFAMPICIN (600 Mg Monthly) (View Rifampicin Review and Rifampicin Label ), DAPSONE (100 Mg Monthly) (View Dapsone Review and Dapsone Label ), MINOCYCLINE HCL (100 Mg Daily) (View Minocycline Hcl Review and Minocycline Hcl Label ). Patient was hospitalized.

6761302-7 | Erythema, Granuloma, Skin Induration, Skin Plaque, Tuberculoid Leprosy, Type Iv Hypersensitivity Reaction
Patient was taking Clofazimine (View Usage). After Clofazimine was administered, patient had the following side effects: erythema, granuloma, skin induration, skin plaque, tuberculoid leprosy, type iv hypersensitivity reaction on Feb 12, 2009 from AUSTRALIA Additional patient health information: Male patient , 30 years of age, was diagnosed with leprosy and. Clofazimine dosage: 50 Mg/day. During the same period patient was treated with RIFAMPICIN (600 Mg Monthly) (View Rifampicin Review and Rifampicin Label ), DAPSONE (100 Mg Daily) (View Dapsone Review and Dapsone Label ).

6532283-6 | Oedema Peripheral, Pain, Type Iv Hypersensitivity Reaction
Adverse event was reported on Nov 18, 2009 by a Male patient taking Clofazimine (View Usage) (Dosage: 50 Mg Per Day) . Location: SWITZERLAND , 24 years of age, Patient experienced the following unwanted or unexpected effects: oedema peripheral, pain (What is pain?), type iv hypersensitivity reaction. During the same period patient was treated with DAPSONE (100 Mg Per Day) (View Dapsone Review and Dapsone Label ), RIFAMPICIN (600 Mg Per Day) (View Rifampicin Review and Rifampicin Label ).

6515800-1 | Abdominal Pain, Abdominal Pain Upper, Anaemia, Apathy, Candidiasis, Decreased Appetite, Diarrhoea, Eschar, Gastritis
on Dec 14, 2009 Female patient from COLOMBIA , 31 years of age, was diagnosed with lepromatous leprosy, skin nodule and was treated with Clofazimine (View Usage). Patient had the following side effects: abdominal pain (What is abdominal pain?), abdominal pain upper, anaemia, apathy, candidiasis, decreased appetite, diarrhoea, eschar, gastritis. Clofazimine dosage: 400 Mg/day. During the same period patient was treated with PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), THALIDOMIDE (View Thalidomide Review and Thalidomide Label ), CORTICOSTEROIDS (View Corticosteroids Review and Corticosteroids Label ).

6382067-7 | Hypersensitivity, Rash
on Sep 18, 2009 Male patient from BRAZIL , 55 years of age, was diagnosed with leprosy and was treated with Clofazimine (View Usage). After Clofazimine was administered, patient had the following side effects: hypersensitivity, rash (What is rash?). Clofazimine dosage: Unk. During the same period patient was treated with RIFAMPICIN (Unk) (View Rifampicin Review and Rifampicin Label ), DAPSONE (Unk) (View Dapsone Review and Dapsone Label ).

6327686-9 | Gangrene, Haemorrhagic Infarction, Hypoalbuminaemia, Hypochromic Anaemia, Liver Palpable Subcostal, Necrosis, Platelet Count Decreased, Purulent Discharge, Rash Papular
Patient was taking Clofazimine (View Usage). Patient experienced the following unwanted or unexpected effects: gangrene, haemorrhagic infarction, hypoalbuminaemia, hypochromic anaemia, liver palpable subcostal, necrosis, platelet count decreased, purulent discharge, rash papular on Aug 20, 2009 from MALAYSIA Additional patient health information: Male patient , 45 years of age, was diagnosed with erythema nodosum leprosum, lepromatous leprosy and. Clofazimine dosage: 50 Mg, Unk. During the same period patient was treated with DAPSONE (100 Mg, Unk) (View Dapsone Review and Dapsone Label ), RIFAMPICIN (600 Mg, Unk) (View Rifampicin Review and Rifampicin Label ), PREDNISOLONE (20 Mg, Tid) (View Prednisolone Review and Prednisolone Label ). Patient was hospitalized.

6301649-1 | Hypersensitivity, Rash
Adverse event was reported on Jul 28, 2009 by a Male patient taking Clofazimine (View Usage) (Dosage: Unk) was diagnosed with leprosy and. Location: BRAZIL , 55 years of age, Patient had the following side effects: hypersensitivity, rash (What is rash?). During the same period patient was treated with RIFAMPICIN (Unk) (View Rifampicin Review and Rifampicin Label ), DAPSONE (Unk) (View Dapsone Review and Dapsone Label ).

6087558-4 | Dermatitis, Granuloma, Leprosy, Neuropathy Peripheral, Pain In Extremity, Tuberculoid Leprosy
on Feb 12, 2009 Female patient from AUSTRALIA , 84 years of age, was diagnosed with leprosy and was treated with Clofazimine (View Usage). After Clofazimine was administered, patient had the following side effects: dermatitis, granuloma, leprosy, neuropathy peripheral, pain in extremity, tuberculoid leprosy. Clofazimine dosage: 50 Mg/day. During the same period patient was treated with RIFAMPICIN (600 Mg Monthly) (View Rifampicin Review and Rifampicin Label ), DAPSONE (100 Mg Monthly) (View Dapsone Review and Dapsone Label ), MINOCYCLINE (100 Mg Daily) (View Minocycline Review and Minocycline Label ). Patient was hospitalized.

6087554-7 | Erythema, Granuloma, Leprosy, Skin Induration, Skin Plaque, Tuberculoid Leprosy
on Feb 12, 2009 Male patient from AUSTRALIA , 30 years of age, was diagnosed with leprosy and was treated with Clofazimine (View Usage). Patient experienced the following unwanted or unexpected effects: erythema, granuloma, leprosy, skin induration, skin plaque, tuberculoid leprosy. Clofazimine dosage: 50 Mg/day. During the same period patient was treated with RIFAMPICIN (600 Mg Monthly) (View Rifampicin Review and Rifampicin Label ), DAPSONE (100 Mg Daily) (View Dapsone Review and Dapsone Label ).

5904383-2 | Anaesthesia, Condition Aggravated, Dysaesthesia, Dyspnoea, Lepromatous Leprosy, Lymphocytic Infiltration, Malaise, Neuropathy Peripheral, Pathology Test
Patient was taking Clofazimine (View Usage). Patient had the following side effects: anaesthesia, condition aggravated, dysaesthesia, dyspnoea, lepromatous leprosy, lymphocytic infiltration, malaise, neuropathy peripheral, pathology test on Sep 26, 2008 from MEXICO Additional patient health information: Male patient , 60 years of age, was diagnosed with lepromatous leprosy and. Clofazimine dosage: 300 Mg/day. During the same period patient was treated with RIFAMPICIN (600 Mg/day) (View Rifampicin Review and Rifampicin Label ), DAPSONE (100 Mg/day) (View Dapsone Review and Dapsone Label ), PREDNISONE (50 Mg/day) (View Prednisone Review and Prednisone Label ), OFLOXACIN (400 Mg/day) (View Ofloxacin Review and Ofloxacin Label ).

5845690-1 | Alopecia, Anaemia, Neuropathy Peripheral, Neutropenia, Tooth Discolouration
Adverse event was reported on Aug 04, 2008 by a Male patient taking Clofazimine (View Usage) (Dosage: Unk) was diagnosed with tuberculosis (What is tuberculosis?) and. Location: UNITED STATES , 38 years of age, After Clofazimine was administered, patient had the following side effects: alopecia, anaemia, neuropathy peripheral, neutropenia, tooth discolouration. During the same period patient was treated with ETHIONAMIDE (Unk) (View Ethionamide Review and Ethionamide Label ), CYCLOSERINE (Unk) (View Cycloserine Review and Cycloserine Label ), MOXIFLOXACIN HCL (Unk) (View Moxifloxacin Hcl Review and Moxifloxacin Hcl Label ), LINEZOLID (Unk) (View Linezolid Review and Linezolid Label ), ANTACID TAB (View Antacid Tab Review and Antacid Tab Label ), ANTIEMETICS (View Antiemetics Review and Antiemetics Label ).

5845685-8 | Eosinophilia, Gastroenteritis, Pneumonectomy, Pulmonary Tuberculosis
on Aug 04, 2008 Female patient from UNITED STATES , 21 years of age, was diagnosed with tuberculosis (What is tuberculosis?) and was treated with Clofazimine (View Usage). Patient experienced the following unwanted or unexpected effects: eosinophilia, gastroenteritis (What is gastroenteritis?), pneumonectomy, pulmonary tuberculosis. Clofazimine dosage: . During the same period patient was treated with CYCLOSERINE (View Cycloserine Review and Cycloserine Label ), MOXIFLOXACIN HCL (View Moxifloxacin Hcl Review and Moxifloxacin Hcl Label ), CAPREOMYCIN (View Capreomycin Review and Capreomycin Label ), ETHAMBUTOL HCL (View Ethambutol Hcl Review and Ethambutol Hcl Label ), LINEZOLID (View Linezolid Review and Linezolid Label ).

5730652-5 | Staphylococcal Sepsis
on Mar 25, 2008 Male patient from INDIA , 65 years of age, was diagnosed with lepromatous leprosy and was treated with Clofazimine (View Usage). Patient had the following side effects: staphylococcal sepsis. Clofazimine dosage: 300 Mg, Qmo. During the same period patient was treated with ANTIBIOTICS (View Antibiotics Review and Antibiotics Label ), DAPSONE (100 Mg/day) (View Dapsone Review and Dapsone Label ), RIFAMPICIN (View Rifampicin Review and Rifampicin Label ).

5713045-6 | Staphylococcal Sepsis
Patient was taking Clofazimine (View Usage). After Clofazimine was administered, patient had the following side effects: staphylococcal sepsis on Mar 25, 2008 from INDIA Additional patient health information: Male patient , 65 years of age, was diagnosed with lepromatous leprosy and. Clofazimine dosage: 300 Mg, Qmo. During the same period patient was treated with ANTIBIOTICS (View Antibiotics Review and Antibiotics Label ), DAPSONE (100 Mg/day) (View Dapsone Review and Dapsone Label ), RIFAMPICIN (View Rifampicin Review and Rifampicin Label ).

5697468-X | Staphylococcal Sepsis
Adverse event was reported on Mar 25, 2008 by a Male patient taking Clofazimine (View Usage) (Dosage: 300 Mg, Qmo) was diagnosed with lepromatous leprosy and. Location: INDIA , 65 years of age, Patient experienced the following unwanted or unexpected effects: staphylococcal sepsis. During the same period patient was treated with ANTIBIOTICS (View Antibiotics Review and Antibiotics Label ), DAPSONE (100 Mg/day) (View Dapsone Review and Dapsone Label ), RIFAMPICIN (View Rifampicin Review and Rifampicin Label ).

5423780-5 | Confusional State, Dyspnoea, Feeding Tube Complication, Intubation
on Aug 14, 2007 Female patient from UNITED STATES , 29 years of age, weighting 116.8 lb, was diagnosed with mycobacterium avium complex infection, nocardiosis, aspergillosis, lung transplant rejection and was treated with Clofazimine (View Usage). Patient had the following side effects: confusional state, dyspnoea, feeding tube complication, intubation. Clofazimine dosage: 100mg Qd. During the same period patient was treated with AZITHROMYCIN (600mg Qd) (View Azithromycin Review and Azithromycin Label ), BACTRIM (500/160 Qd) (View Bactrim Review and Bactrim Label ), VORICONAZOLE (200mg Bid) (View Voriconazole Review and Voriconazole Label ), CASPOFUNGIN (5mg Qd) (View Caspofungin Review and Caspofungin Label ), TACROLIMUS (4mg Q12h) (View Tacrolimus Review and Tacrolimus Label ).

4879862-X | Abdominal Pain, Dehydration, Diarrhoea, Dizziness, Hypokalaemia, Hypotension, Ichthyosis
on May 12, 2003 Female patient from INDIA , 45 years of age, was diagnosed with lepromatous leprosy and was treated with Clofazimine (View Usage). After Clofazimine was administered, patient had the following side effects: abdominal pain (What is abdominal pain?), dehydration, diarrhoea, dizziness (What is dizziness?), hypokalaemia, hypotension, ichthyosis. Clofazimine dosage: 300 Mg, Qd. Patient was hospitalized.

4728115-9 | Grand Mal Convulsion, Hyperbilirubinaemia, Hypoaesthesia, Optic Neuropathy, Renal Disorder, Visual Acuity Reduced
Patient was taking Clofazimine (View Usage). Patient experienced the following unwanted or unexpected effects: grand mal convulsion, hyperbilirubinaemia, hypoaesthesia, optic neuropathy, renal disorder, visual acuity reduced on Jul 18, 2005 from SPAIN Additional patient health information: Male patient , 68 years of age, was diagnosed with pulmonary tuberculosis and. Clofazimine dosage: 100 Mg/day. During the same period patient was treated with LINEZOLID (600 Mg, Q12h) (View Linezolid Review and Linezolid Label ), CYCLOSERINE (250 Mg, Q12h) (View Cycloserine Review and Cycloserine Label ), METRONIDAZOLE (500 Mg, Q8h) (View Metronidazole Review and Metronidazole Label ), CAPREOMYCIN (1 G/day) (View Capreomycin Review and Capreomycin Label ), FUSIDIC ACID (1 G, Q8h) (View Fusidic Acid Review and Fusidic Acid Label ), AMOXICILLIN AND CLAVULANATE POTASSIUM (1 G, Q6h) (View Amoxicillin And Clavulanate Potassium Review and Amoxicillin And Clavulanate Potassium Label ).

4714310-1 | Gastrointestinal Disorder, Normal Newborn
Adverse event was reported on Oct 13, 2004 by a Female patient taking Clofazimine (View Usage) (Dosage: ) was diagnosed with tuberculosis (What is tuberculosis?) and. Location: UNITED STATES , 24 years of age, Patient had the following side effects: gastrointestinal disorder, normal newborn. During the same period patient was treated with AMIKACIN (View Amikacin Review and Amikacin Label ), ETHAMBUTOL HCL (View Ethambutol Hcl Review and Ethambutol Hcl Label ), SPARFLOXACIN (View Sparfloxacin Review and Sparfloxacin Label ), CYCLOSERINE (View Cycloserine Review and Cycloserine Label ), PARA AMINOSALICYLATE ACID POWDER (View Para-aminosalicylate Acid Powder Review and Para-aminosalicylate Acid Powder Label ), AMOXICILLIN W/CLAVULANIC ACID (View Amoxicillin W/clavulanic Acid Review and Amoxicillin W/clavulanic Acid Label ).

4662288-1 | Cushingoid, Diabetes Mellitus, Haemoglobin Decreased, Peptic Ulcer Perforation, Peritonitis, Wound Dehiscence
on Apr 27, 2005 Male patient from , 63 years of age, was diagnosed with pyoderma gangrenosum and was treated with Clofazimine (View Usage). After Clofazimine was administered, patient had the following side effects: cushingoid, diabetes mellitus, haemoglobin decreased, peptic ulcer perforation, peritonitis, wound dehiscence. Clofazimine dosage: . During the same period patient was treated with METHOTREXATE (7.5 Mg, Qw) (View Methotrexate Review and Methotrexate Label ), CELLCEPT (500 Mg, Bid) (View Cellcept Review and Cellcept Label ), DERMOVATE (View Dermovate Review and Dermovate Label ), THALIDOMIDE (150 Mg, Qd) (View Thalidomide Review and Thalidomide Label ), KENALOG (View Kenalog Review and Kenalog Label ), FILGRASTIM (400 Ug, Qd) (View Filgrastim Review and Filgrastim Label ), METHYLPREDNISOLONE (40-80mg Qd) (View Methylprednisolone Review and Methylprednisolone Label ). Patient was hospitalized.

4657656-8 | Cushingoid, Diabetes Mellitus, Haemoglobin Decreased, Peptic Ulcer Perforation, Peritonitis, Wound Dehiscence
on Apr 27, 2005 Male patient from , 63 years of age, was diagnosed with pyoderma gangrenosum and was treated with Clofazimine (View Usage). Patient experienced the following unwanted or unexpected effects: cushingoid, diabetes mellitus, haemoglobin decreased, peptic ulcer perforation, peritonitis, wound dehiscence. Clofazimine dosage: . During the same period patient was treated with METHOTREXATE (7.5 Mg, Qw) (View Methotrexate Review and Methotrexate Label ), CELLCEPT (500 Mg, Bid) (View Cellcept Review and Cellcept Label ), DERMOVATE (View Dermovate Review and Dermovate Label ), THALIDOMIDE (150 Mg, Qd) (View Thalidomide Review and Thalidomide Label ), TRIAMCINOLONE (View Triamcinolone Review and Triamcinolone Label ), FILGRASTIM (400 Ug, Qd) (View Filgrastim Review and Filgrastim Label ), METHYLPREDNISOLONE (40-80mg Qd) (View Methylprednisolone Review and Methylprednisolone Label ). Patient was hospitalized.

4656403-3 | Cushingoid, Diabetes Mellitus, Haemoglobin Decreased, Peptic Ulcer Perforation, Peritonitis, Wound Dehiscence
Patient was taking Clofazimine (View Usage). Patient had the following side effects: cushingoid, diabetes mellitus, haemoglobin decreased, peptic ulcer perforation, peritonitis, wound dehiscence on Apr 27, 2005 from Additional patient health information: Male patient , 63 years of age, was diagnosed with pyoderma gangrenosum and. Clofazimine dosage: . During the same period patient was treated with METHOTREXATE (7.5 Mg, Qw) (View Methotrexate Review and Methotrexate Label ), CELLCEPT (500 Mg, Bid) (View Cellcept Review and Cellcept Label ), DERMOVATE (View Dermovate Review and Dermovate Label ), THALIDOMIDE (150 Mg, Qd) (View Thalidomide Review and Thalidomide Label ), TRIAMCINOLONE (View Triamcinolone Review and Triamcinolone Label ), NEUPOGEN (400 Ug, Qd) (View Neupogen Review and Neupogen Label ), METHYLPREDNISOLONE (40-80mg Qd) (View Methylprednisolone Review and Methylprednisolone Label ). Patient was hospitalized.

4639886-4 | Oedema Peripheral, Rash, Red Blood Cell Sedimentation Rate Increased, Vasculitis
Adverse event was reported on Apr 12, 2005 by a Male patient taking Clofazimine (View Usage) (Dosage: ) was diagnosed with lepromatous leprosy and. Location: , 41 years of age, After Clofazimine was administered, patient had the following side effects: oedema peripheral, rash (What is rash?), red blood cell sedimentation rate increased, vasculitis (What is vasculitis?). During the same period patient was treated with RIFAMPICIN (View Rifampicin Review and Rifampicin Label ), DAPSONE (View Dapsone Review and Dapsone Label ).