Drug information for REBETOL
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
CAPSULE; ORAL
200MG
Prescription
AB (Reference Drug)
RIBAVIRIN
Ribavirin
SCHERING PLOUGH RES
20903
2011-05-10 Letter
2010-11-03 Letter
2010-10-29 Medication Guide
2010-10-29 Label
2010-10-29 Other
2010-01-20 Letter
2010-01-20 Letter
2010-01-20 Letter
2010-01-20 Letter
2009-11-18 Other
2009-11-16 Label
2009-11-16 Label
2009-11-16 Label
2009-11-16 Label
2008-08-01 Review
2008-08-01 Review
2008-01-09 Letter
2007-12-14 Label
2007-04-20 Label
2007-04-20 Letter
2007-02-20 Medication Guide
2006-09-18 Letter
2006-08-29 Label
2005-04-15 Review
2005-04-15 Review
2005-04-15 Review
2005-04-15 Review
2005-04-15 Review
2004-06-24 Letter
2004-06-24 Label
2004-06-14 Letter
2004-06-10 Letter
2004-06-10 Label
2004-06-04 Review
2004-06-04 Review
2003-12-17 Medication Guide
2003-10-16 Letter
2003-10-16 Label
2003-08-08 Review
2003-07-31 Letter
2003-07-09 Label
2003-06-22 Label
2003-06-22 Letter
2003-06-08 Label
2003-06-08 Letter
2003-04-25 Label
2003-04-25 Label
2003-04-25 Label
2003-04-25 Label
2002-11-13 Label
2002-09-03 Letter
2002-09-03 Label
2002-03-06 Letter
2002-02-21 Letter
2001-12-28 Letter
2001-07-26 Letter
2001-07-26 Label
2001-07-26 Label
2001-07-26 Letter
2001-07-26 Letter
2001-07-26 Label
2001-07-26 Label
2001-07-26 Letter
2001-03-13 Letter
2001-03-13 Letter
1998-12-09 Label
1998-12-09 Letter
1998-12-09 Label
1998-12-09 Letter
1998-06-03 Label
1998-06-03 Letter
CAPSULE; ORAL
200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy**
Prescription
(Reference Drug)
RIBAVIRIN
Ribavirin
SCHERING PLOUGH RES
"
SOLUTION; ORAL
40MG/ML
Prescription
(Reference Drug)
RIBAVIRIN
Ribavirin
SCHERING
21546
2011-05-10 Letter
2010-11-03 Letter
2010-10-29 Other
2010-10-29 Medication Guide
2010-10-29 Label
2010-01-20 Letter
2009-11-16 Other
2009-11-16 Label
2007-02-20 Medication Guide
2005-04-08 Review
2004-06-14 Label
2003-08-06 Letter
Drug Adverse Effects information for REBETOL
Role code
Indications
Reaction
# Reports
PS
HEPATITIS
RENAL IMPAIRMENT
1
PS
HEPATITIS C
ANAEMIA
4
PS
HEPATITIS C
ANTINUCLEAR ANTIBODY POSITIVE
2
PS
HEPATITIS C
BACK PAIN
2
PS
HEPATITIS C
CHILLS
2
PS
HEPATITIS C
CONDITION AGGRAVATED
4
PS
HEPATITIS C
DEPRESSION
4
PS
HEPATITIS C
DERMATITIS
2
PS
HEPATITIS C
DIZZINESS
4
PS
HEPATITIS C
DNA ANTIBODY POSITIVE
2
PS
HEPATITIS C
DYSARTHRIA
4
PS
HEPATITIS C
DYSKINESIA
2
PS
HEPATITIS C
DYSLALIA
4
PS
HEPATITIS C
DYSPHORIA
2
PS
HEPATITIS C
GAIT DISTURBANCE
2
PS
HEPATITIS C
HEPATIC NEOPLASM MALIGNANT
2
PS
HEPATITIS C
HYPERTHYROIDISM
4
PS
HEPATITIS C
HYPERURICAEMIA
4
PS
HEPATITIS C
HYPOTENSION
2
PS
HEPATITIS C
IMPULSIVE BEHAVIOUR
2
PS
HEPATITIS C
INFECTIVE SPONDYLITIS
2
PS
HEPATITIS C
INTERVERTEBRAL DISC PROTRUSION
2
PS
HEPATITIS C
MALAISE
2
PS
HEPATITIS C
MYALGIA
2
PS
HEPATITIS C
NEUTROPENIA
4
PS
HEPATITIS C
PAIN
2
PS
HEPATITIS C
PROTEINURIA
2
PS
HEPATITIS C
PYREXIA
6
PS
HEPATITIS C
SEPSIS
2
PS
HEPATITIS C
SPONDYLITIS
2
PS
HEPATITIS C
SYSTEMIC LUPUS ERYTHEMATOSUS
2
PS
HEPATITIS C
TACHYCARDIA
2
PS
HEPATITIS C
THROMBOCYTOPENIA
2
PS
HEPATITIS C
TRANSIENT ISCHAEMIC ATTACK
2
PS
HEPATITIS C
VOMITING
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
RENAL IMPAIRMENT
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
SYNCOPE
1
SS
ABDOMINAL PAIN UPPER
BODY HEIGHT INCREASED
1
SS
ABDOMINAL PAIN UPPER
BURNING SENSATION
1
SS
ABDOMINAL PAIN UPPER
FEELING ABNORMAL
1
SS
ABDOMINAL PAIN UPPER
HYPOAESTHESIA
1
SS
ABDOMINAL PAIN UPPER
INTERVERTEBRAL DISC PROTRUSION
1
SS
ABDOMINAL PAIN UPPER
MALAISE
1
SS
ABDOMINAL PAIN UPPER
MUSCLE SPASMS
1
SS
ABDOMINAL PAIN UPPER
OVERDOSE
1
SS
ABDOMINAL PAIN UPPER
PAIN
1
SS
ABDOMINAL PAIN UPPER
PULSE ABSENT
1
SS
ABDOMINAL PAIN UPPER
THYROID DISORDER
1
SS
ABDOMINAL PAIN UPPER
WEIGHT DECREASED
1
SS
ABDOMINAL PAIN UPPER
WEIGHT INCREASED
1
SS
ESSENTIAL HYPERTENSION
LYMPHOMA
2
SS
ESSENTIAL HYPERTENSION
POLYGLANDULAR AUTOIMMUNE SYNDROME TYPE II
2
SS
HEPATIC CIRRHOSIS
BLOOD BILIRUBIN INCREASED
2
SS
HEPATIC CIRRHOSIS
BRAIN ABSCESS
1
SS
HEPATIC CIRRHOSIS
BRAIN OEDEMA
1
SS
HEPATIC CIRRHOSIS
CARDIAC ARREST
1
SS
HEPATIC CIRRHOSIS
CENTRAL NERVOUS SYSTEM LESION
1
SS
HEPATIC CIRRHOSIS
CEREBRAL ASPERGILLOSIS
1
SS
HEPATIC CIRRHOSIS
CEREBRAL HAEMORRHAGE
1
SS
HEPATIC CIRRHOSIS
DIABETES MELLITUS
2
SS
HEPATIC CIRRHOSIS
ENCEPHALOPATHY
1
SS
HEPATIC CIRRHOSIS
GENERAL PHYSICAL HEALTH DETERIORATION
1
SS
HEPATIC CIRRHOSIS
HAEMODYNAMIC INSTABILITY
1
SS
HEPATIC CIRRHOSIS
HAEMOLYTIC ANAEMIA
2
SS
HEPATIC CIRRHOSIS
HEPATIC ENCEPHALOPATHY
1
SS
HEPATIC CIRRHOSIS
LEUKOPENIA
2
SS
HEPATIC CIRRHOSIS
LYMPHOMA
12
SS
HEPATIC CIRRHOSIS
NEUTROPENIA
3
SS
HEPATIC CIRRHOSIS
NO THERAPEUTIC RESPONSE
1
SS
HEPATIC CIRRHOSIS
POLYGLANDULAR AUTOIMMUNE SYNDROME TYPE II
12
SS
HEPATIC CIRRHOSIS
PYREXIA
3
SS
HEPATIC CIRRHOSIS
THROMBOCYTOPENIA
2
SS
HEPATIC CIRRHOSIS
TUBERCULOSIS OF CENTRAL NERVOUS SYSTEM
1
SS
HEPATIC CIRRHOSIS
WHITE BLOOD CELL COUNT DECREASED
3
SS
HEPATIC NEOPLASM MALIGNANT
OESOPHAGEAL VARICES HAEMORRHAGE
2
SS
HEPATITIS C
ABDOMINAL DISTENSION
2
SS
HEPATITIS C
ABORTION SPONTANEOUS
2
SS
HEPATITIS C
ABSCESS
3
SS
HEPATITIS C
ACTIVITIES OF DAILY LIVING IMPAIRED
2
SS
HEPATITIS C
ACUTE LEUKAEMIA
6
SS
HEPATITIS C
ADVERSE EVENT
2
SS
HEPATITIS C
AGEUSIA
3
SS
HEPATITIS C
AGITATION
2
SS
HEPATITIS C
ALANINE AMINOTRANSFERASE INCREASED
2
SS
HEPATITIS C
ALTERED STATE OF CONSCIOUSNESS
2
SS
HEPATITIS C
AMNESIA
2
SS
HEPATITIS C
AMYOTROPHIC LATERAL SCLEROSIS
4
SS
HEPATITIS C
ANAEMIA
15
SS
HEPATITIS C
ANTINEUTROPHIL CYTOPLASMIC ANTIBODY INCREASED
3
SS
HEPATITIS C
ANXIETY
3
SS
HEPATITIS C
ARTHRALGIA
3
SS
HEPATITIS C
ASCITES
5
SS
HEPATITIS C
ASPARTATE AMINOTRANSFERASE INCREASED
4
SS
HEPATITIS C
ASTHENIA
26
SS
HEPATITIS C
ATELECTASIS
2
SS
HEPATITIS C
ATRIAL FIBRILLATION
3
SS
HEPATITIS C
AUTOIMMUNE HEPATITIS
2
SS
HEPATITIS C
BACK PAIN
5
SS
HEPATITIS C
BACTERAEMIA
3
SS
HEPATITIS C
BLISTER
3
SS
HEPATITIS C
BLOOD BILIRUBIN INCREASED
4
SS
HEPATITIS C
BLOOD CREATINE PHOSPHOKINASE INCREASED
2
SS
HEPATITIS C
BLOOD CREATININE INCREASED
6
SS
HEPATITIS C
BLOOD GLUCOSE INCREASED
2
SS
HEPATITIS C
BLOOD PRESSURE DECREASED
2
SS
HEPATITIS C
BODY HEIGHT INCREASED
4
SS
HEPATITIS C
BODY TEMPERATURE INCREASED
3
SS
HEPATITIS C
BONE MARROW FAILURE
2
SS
HEPATITIS C
BRONCHITIS
2
SS
HEPATITIS C
BULLOUS IMPETIGO
9
SS
HEPATITIS C
BURNING SENSATION
4
SS
HEPATITIS C
CALCULUS BLADDER
2
SS
HEPATITIS C
CAPSULE PHYSICAL ISSUE
1
SS
HEPATITIS C
CARDIAC ARREST
2
SS
HEPATITIS C
CARDIAC FAILURE ACUTE
2
SS
HEPATITIS C
CARDIOMEGALY
3
SS
HEPATITIS C
CD4 LYMPHOCYTES DECREASED
3
SS
HEPATITIS C
CELLULITIS
16
SS
HEPATITIS C
CEREBRAL INFARCTION
2
SS
HEPATITIS C
CHEILITIS
1
SS
HEPATITIS C
CHILLS
4
SS
HEPATITIS C
CHOKING
1
SS
HEPATITIS C
CHOLESTASIS
2
SS
HEPATITIS C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
2
SS
HEPATITIS C
CLOSTRIDIAL INFECTION
3
SS
HEPATITIS C
COLITIS
3
SS
HEPATITIS C
COLITIS ISCHAEMIC
2
SS
HEPATITIS C
COLONIC POLYP
3
SS
HEPATITIS C
CONDITION AGGRAVATED
3
SS
HEPATITIS C
CONFUSIONAL STATE
3
SS
HEPATITIS C
CONJUNCTIVITIS
6
SS
HEPATITIS C
CONJUNCTIVITIS INFECTIVE
3
SS
HEPATITIS C
CONSTIPATION
7
SS
HEPATITIS C
CONTINUOUS HAEMODIAFILTRATION
2
SS
HEPATITIS C
COUGH
2
SS
HEPATITIS C
CREATININE RENAL CLEARANCE DECREASED
9
SS
HEPATITIS C
CREPITATIONS
4
SS
HEPATITIS C
CRYING
3
SS
HEPATITIS C
CULTURE WOUND POSITIVE
2
SS
HEPATITIS C
CUTANEOUS SARCOIDOSIS
2
SS
HEPATITIS C
CYSTITIS HAEMORRHAGIC
2
SS
HEPATITIS C
CYTOLYTIC HEPATITIS
2
SS
HEPATITIS C
DECREASED APPETITE
2
SS
HEPATITIS C
DECUBITUS ULCER
2
SS
HEPATITIS C
DEHYDRATION
13
SS
HEPATITIS C
DEPRESSED LEVEL OF CONSCIOUSNESS
2
SS
HEPATITIS C
DEPRESSION
7
SS
HEPATITIS C
DEPRESSIVE SYMPTOM
2
SS
HEPATITIS C
DERMATITIS ALLERGIC
6
SS
HEPATITIS C
DERMATITIS EXFOLIATIVE
3
SS
HEPATITIS C
DIABETES MELLITUS
1
SS
HEPATITIS C
DIABETES MELLITUS INADEQUATE CONTROL
2
SS
HEPATITIS C
DIALYSIS
2
SS
HEPATITIS C
DIARRHOEA
7
SS
HEPATITIS C
DISEASE RECURRENCE
2
SS
HEPATITIS C
DIZZINESS
7
SS
HEPATITIS C
DRUG ABUSE
3
SS
HEPATITIS C
DRUG HYPERSENSITIVITY
4
SS
HEPATITIS C
DRUG INTOLERANCE
2
SS
HEPATITIS C
DRY MOUTH
5
SS
HEPATITIS C
DYSGEUSIA
3
SS
HEPATITIS C
DYSLALIA
2
SS
HEPATITIS C
DYSPNOEA
14
SS
HEPATITIS C
EAR DISCOMFORT
3
SS
HEPATITIS C
EAR PAIN
3
SS
HEPATITIS C
EFFUSION
3
SS
HEPATITIS C
ELECTROLYTE IMBALANCE
3
SS
HEPATITIS C
ENCEPHALOPATHY
1
SS
HEPATITIS C
ERYSIPELAS
18
SS
HEPATITIS C
EXCORIATION
3
SS
HEPATITIS C
EYE SWELLING
5
SS
HEPATITIS C
FALL
7
SS
HEPATITIS C
FATIGUE
6
SS
HEPATITIS C
FEELING ABNORMAL
6
SS
HEPATITIS C
FIBRIN D DIMER INCREASED
2
SS
HEPATITIS C
FOOT FRACTURE
3
SS
HEPATITIS C
FUNGAL INFECTION
3
SS
HEPATITIS C
GAIT DISTURBANCE
4
SS
HEPATITIS C
GASTRITIS
3
SS
HEPATITIS C
GASTROENTERITIS
2
SS
HEPATITIS C
GASTROINTESTINAL DISORDER
3
SS
HEPATITIS C
GASTROINTESTINAL NEOPLASM
6
SS
HEPATITIS C
GASTROINTESTINAL VASCULAR MALFORMATION
3
SS
HEPATITIS C
GASTROOESOPHAGEAL REFLUX DISEASE
6
SS
HEPATITIS C
GENERAL PHYSICAL HEALTH DETERIORATION
8
SS
HEPATITIS C
GENERALISED OEDEMA
3
SS
HEPATITIS C
GINGIVAL BLEEDING
2
SS
HEPATITIS C
GINGIVITIS
3
SS
HEPATITIS C
GLOMERULONEPHRITIS MEMBRANOUS
2
SS
HEPATITIS C
GLYCOSYLATED HAEMOGLOBIN INCREASED
2
SS
HEPATITIS C
GRIP STRENGTH DECREASED
2
SS
HEPATITIS C
HAEMANGIOMA OF LIVER
2
SS
HEPATITIS C
HAEMATOCRIT DECREASED
2
SS
HEPATITIS C
HAEMATURIA
2
SS
HEPATITIS C
HAEMOGLOBIN DECREASED
4
SS
HEPATITIS C
HAEMOLYSIS
3
SS
HEPATITIS C
HAEMOLYTIC ANAEMIA
1
SS
HEPATITIS C
HAEMOLYTIC URAEMIC SYNDROME
2
SS
HEPATITIS C
HAEMOPTYSIS
8
SS
HEPATITIS C
HAEMORRHAGE
5
SS
HEPATITIS C
HAEMORRHOIDS
3
SS
HEPATITIS C
HEAD INJURY
4
SS
HEPATITIS C
HEADACHE
1
SS
HEPATITIS C
HEMIPARESIS
2
SS
HEPATITIS C
HEPATIC CIRRHOSIS
15
SS
HEPATITIS C
HEPATIC ENCEPHALOPATHY
4
SS
HEPATITIS C
HEPATIC NEOPLASM MALIGNANT
7
SS
HEPATITIS C
HEPATIC STEATOSIS
3
SS
HEPATITIS C
HEPATITIS C RNA INCREASED
2
SS
HEPATITIS C
HOSPITALISATION
1
SS
HEPATITIS C
HYPERKALAEMIA
3
SS
HEPATITIS C
HYPERSENSITIVITY
2
SS
HEPATITIS C
HYPERVENTILATION
2
SS
HEPATITIS C
HYPOAESTHESIA
8
SS
HEPATITIS C
HYPOGLYCAEMIA
2
SS
HEPATITIS C
HYPONATRAEMIA
7
SS
HEPATITIS C
HYPOPHOSPHATAEMIA
2
SS
HEPATITIS C
HYPOTENSION
3
SS
HEPATITIS C
HYPOTHERMIA
2
SS
HEPATITIS C
HYPOTHYROIDISM
3
SS
HEPATITIS C
HYPOXIA
2
SS
HEPATITIS C
HYSTERECTOMY
3
SS
HEPATITIS C
ILEUS PARALYTIC
5
SS
HEPATITIS C
IMPAIRED WORK ABILITY
2
SS
HEPATITIS C
IMPETIGO
3
SS
HEPATITIS C
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
4
SS
HEPATITIS C
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
3
SS
HEPATITIS C
INCORRECT STORAGE OF DRUG
1
SS
HEPATITIS C
INFECTION
5
SS
HEPATITIS C
INFECTIOUS MONONUCLEOSIS
3
SS
HEPATITIS C
INFLUENZA LIKE ILLNESS
3
SS
HEPATITIS C
INJECTION SITE CELLULITIS
2
SS
HEPATITIS C
INJECTION SITE ERYTHEMA
7
SS
HEPATITIS C
INJECTION SITE PRURITUS
4
SS
HEPATITIS C
INJECTION SITE REACTION
2
SS
HEPATITIS C
INSOMNIA
9
SS
HEPATITIS C
INTERSTITIAL LUNG DISEASE
2
SS
HEPATITIS C
INTERVERTEBRAL DISC PROTRUSION
4
SS
HEPATITIS C
IRON DEFICIENCY ANAEMIA
6
SS
HEPATITIS C
LARYNGOSPASM
2
SS
HEPATITIS C
LEUKOPENIA
9
SS
HEPATITIS C
LIP SWELLING
3
SS
HEPATITIS C
LOCALISED INFECTION
2
SS
HEPATITIS C
LOSS OF CONSCIOUSNESS
5
SS
HEPATITIS C
LOSS OF LIBIDO
1
SS
HEPATITIS C
LUNG DISORDER
4
SS
HEPATITIS C
LUNG NEOPLASM
3
SS
HEPATITIS C
LYMPHADENOPATHY
3
SS
HEPATITIS C
MALAISE
11
SS
HEPATITIS C
MATERNAL EXPOSURE DURING PREGNANCY
2
SS
HEPATITIS C
MENTAL STATUS CHANGES
3
SS
HEPATITIS C
MONOCYTOSIS
3
SS
HEPATITIS C
MOUTH HAEMORRHAGE
3
SS
HEPATITIS C
MULTI-ORGAN FAILURE
1
SS
HEPATITIS C
MUSCLE CONTRACTIONS INVOLUNTARY
2
SS
HEPATITIS C
MUSCLE NECROSIS
2
SS
HEPATITIS C
MUSCLE SPASMS
4
SS
HEPATITIS C
MUSCULAR WEAKNESS
5
SS
HEPATITIS C
MUSCULOSKELETAL PAIN
1
SS
HEPATITIS C
MUSCULOSKELETAL STIFFNESS
4
SS
HEPATITIS C
MYALGIA
2
SS
HEPATITIS C
MYELODYSPLASTIC SYNDROME
2
SS
HEPATITIS C
NAUSEA
18
SS
HEPATITIS C
NECROTISING FASCIITIS
2
SS
HEPATITIS C
NEUTROPENIA
18
SS
HEPATITIS C
NEUTROPHIL COUNT DECREASED
4
SS
HEPATITIS C
NORMOCHROMIC NORMOCYTIC ANAEMIA
2
SS
HEPATITIS C
OCCULT BLOOD POSITIVE
3
SS
HEPATITIS C
OEDEMA PERIPHERAL
3
SS
HEPATITIS C
OEDEMATOUS PANCREATITIS
2
SS
HEPATITIS C
OESOPHAGEAL VARICES HAEMORRHAGE
2
SS
HEPATITIS C
ORAL FUNGAL INFECTION
3
SS
HEPATITIS C
ORAL PAIN
3
SS
HEPATITIS C
OROPHARYNGEAL PAIN
1
SS
HEPATITIS C
OROPHARYNGEAL SPASM
2
SS
HEPATITIS C
OVERDOSE
4
SS
HEPATITIS C
PAIN
8
SS
HEPATITIS C
PALPITATIONS
3
SS
HEPATITIS C
PARAESTHESIA
2
SS
HEPATITIS C
PELVIC INFECTION
2
SS
HEPATITIS C
PERFORMANCE STATUS DECREASED
2
SS
HEPATITIS C
PERICHONDRITIS
2
SS
HEPATITIS C
PERITONEAL TUBERCULOSIS
2
SS
HEPATITIS C
PERITONITIS BACTERIAL
2
SS
HEPATITIS C
PHARYNGEAL HAEMORRHAGE
2
SS
HEPATITIS C
PHARYNGITIS STREPTOCOCCAL
3
SS
HEPATITIS C
PLATELET COUNT DECREASED
9
SS
HEPATITIS C
PLEURAL EFFUSION
3
SS
HEPATITIS C
PLEURAL INFECTION
3
SS
HEPATITIS C
PLEURISY
2
SS
HEPATITIS C
PNEUMONIA
8
SS
HEPATITIS C
PNEUMONIA STREPTOCOCCAL
2
SS
HEPATITIS C
POLYNEUROPATHY
2
SS
HEPATITIS C
PORTAL VEIN THROMBOSIS
6
SS
HEPATITIS C
POST PROCEDURAL HAEMORRHAGE
2
SS
HEPATITIS C
POST PROCEDURAL INFECTION
1
SS
HEPATITIS C
PRODUCT TASTE ABNORMAL
1
SS
HEPATITIS C
PROTHROMBIN TIME PROLONGED
3
SS
HEPATITIS C
PRURITUS
3
SS
HEPATITIS C
PULMONARY EMBOLISM
2
SS
HEPATITIS C
PULMONARY GRANULOMA
2
SS
HEPATITIS C
PULMONARY SARCOIDOSIS
2
SS
HEPATITIS C
PULSE ABSENT
4
SS
HEPATITIS C
PYELONEPHRITIS
2
SS
HEPATITIS C
PYODERMA GANGRENOSUM
9
SS
HEPATITIS C
PYREXIA
14
SS
HEPATITIS C
RASH
5
SS
HEPATITIS C
RASH ERYTHEMATOUS
2
SS
HEPATITIS C
RASH PRURITIC
7
SS
HEPATITIS C
REFUSAL OF TREATMENT BY PATIENT
2
SS
HEPATITIS C
RENAL FAILURE ACUTE
7
SS
HEPATITIS C
RESPIRATORY DISORDER
3
SS
HEPATITIS C
RESPIRATORY DISTRESS
2
SS
HEPATITIS C
RESPIRATORY FAILURE
4
SS
HEPATITIS C
RESTLESS LEGS SYNDROME
3
SS
HEPATITIS C
RETINAL ARTERY OCCLUSION
2
SS
HEPATITIS C
RETINAL HAEMORRHAGE
3
SS
HEPATITIS C
RETINAL VEIN OCCLUSION
2
SS
HEPATITIS C
RHABDOMYOLYSIS
4
SS
HEPATITIS C
SCRATCH
3
SS
HEPATITIS C
SEPSIS
2
SS
HEPATITIS C
SEPTIC EMBOLUS
3
SS
HEPATITIS C
SEPTIC SHOCK
6
SS
HEPATITIS C
SKIN EXFOLIATION
3
SS
HEPATITIS C
SOMNOLENCE
2
SS
HEPATITIS C
SPLENIC INFARCTION
3
SS
HEPATITIS C
SPLENOMEGALY
3
SS
HEPATITIS C
STAPHYLOCOCCAL INFECTION
3
SS
HEPATITIS C
STAPHYLOCOCCUS TEST POSITIVE
2
SS
HEPATITIS C
STILL'S DISEASE ADULT ONSET
2
SS
HEPATITIS C
STOMATITIS
6
SS
HEPATITIS C
SUBDURAL HAEMATOMA
4
SS
HEPATITIS C
SUICIDE ATTEMPT
2
SS
HEPATITIS C
SWELLING
1
SS
HEPATITIS C
SWOLLEN TONGUE
3
SS
HEPATITIS C
SYNCOPE
3
SS
HEPATITIS C
TACHYCARDIA
5
SS
HEPATITIS C
THERAPEUTIC PRODUCT INEFFECTIVE
3
SS
HEPATITIS C
THINKING ABNORMAL
3
SS
HEPATITIS C
THROMBOCYTOPENIA
5
SS
HEPATITIS C
THYROID DISORDER
2
SS
HEPATITIS C
TONGUE DRY
3
SS
HEPATITIS C
TONGUE HAEMORRHAGE
2
SS
HEPATITIS C
TREMOR
11
SS
HEPATITIS C
UNEVALUABLE EVENT
3
SS
HEPATITIS C
URINARY TRACT INFECTION STAPHYLOCOCCAL
3
SS
HEPATITIS C
UTERINE LEIOMYOMA
3
SS
HEPATITIS C
VAGINAL HAEMORRHAGE
2
SS
HEPATITIS C
VENTRICULAR EXTRASYSTOLES
3
SS
HEPATITIS C
VENTRICULAR TACHYCARDIA
3
SS
HEPATITIS C
VIITH NERVE PARALYSIS
2
SS
HEPATITIS C
VIRAL LOAD INCREASED
3
SS
HEPATITIS C
VISION BLURRED
3
SS
HEPATITIS C
VITREOUS FLOATERS
5
SS
HEPATITIS C
VOMITING
19
SS
HEPATITIS C
WEIGHT DECREASED
5
SS
HEPATITIS C
WEIGHT INCREASED
4
SS
HEPATITIS C
WHITE BLOOD CELL COUNT DECREASED
5
SS
HEPATITIS C
WITHDRAWAL SYNDROME
2
SS
HEPATITIS C
WOUND INFECTION
9
SS
HEPATITIS C
WRONG TECHNIQUE IN DRUG USAGE PROCESS
3
SS
HEPATITIS POST TRANSFUSION
ASTHENIA
1
SS
HEPATITIS POST TRANSFUSION
BLOOD CREATININE INCREASED
1
SS
HEPATITIS POST TRANSFUSION
C-REACTIVE PROTEIN INCREASED
1
SS
HEPATITIS POST TRANSFUSION
HYPERTHERMIA
1
SS
HEPATITIS POST TRANSFUSION
PANCYTOPENIA
1
SS
HEPATITIS VIRAL
CEREBRAL HAEMORRHAGE
2
SS
HEPATITIS VIRAL
SUBDURAL HAEMORRHAGE
2
SS
HEPATITIS VIRAL
THROMBOCYTOPENIA
2
SS
HYPOTHYROIDISM
LYMPHOMA
2
SS
HYPOTHYROIDISM
POLYGLANDULAR AUTOIMMUNE SYNDROME TYPE II
2
SS
NO THERAPEUTIC RESPONSE
BLOOD BILIRUBIN INCREASED
1
SS
NO THERAPEUTIC RESPONSE
DIABETES MELLITUS
1
SS
NO THERAPEUTIC RESPONSE
ENCEPHALOPATHY
1
SS
NO THERAPEUTIC RESPONSE
HAEMOLYTIC ANAEMIA
1
SS
NO THERAPEUTIC RESPONSE
LEUKOPENIA
1
SS
NO THERAPEUTIC RESPONSE
THROMBOCYTOPENIA
1
SS
PAIN
ACTIVITIES OF DAILY LIVING IMPAIRED
1
SS
PAIN
BODY HEIGHT INCREASED
2
SS
PAIN
BURNING SENSATION
2
SS
PAIN
FEELING ABNORMAL
1
SS
PAIN
HYPOAESTHESIA
2
SS
PAIN
INTERVERTEBRAL DISC PROTRUSION
2
SS
PAIN
MALAISE
1
SS
PAIN
MUSCLE SPASMS
2
SS
PAIN
OVERDOSE
2
SS
PAIN
PAIN
2
SS
PAIN
PULSE ABSENT
2
SS
PAIN
THYROID DISORDER
1
SS
PAIN
WEIGHT DECREASED
1
SS
PAIN
WEIGHT INCREASED
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
ADRENAL INSUFFICIENCY
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
ANAEMIA
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
ANXIETY
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
ASTHENIA
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
BLISTER
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
BLOOD BILIRUBIN INCREASED
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
BRAIN ABSCESS
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
BRAIN OEDEMA
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
CAPSULE PHYSICAL ISSUE
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
CARDIAC ARREST
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
CENTRAL NERVOUS SYSTEM LESION
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
CEREBRAL ASPERGILLOSIS
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
CEREBRAL HAEMORRHAGE
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
CHEILITIS
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
CHOKING
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
COLITIS
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
DIABETES MELLITUS
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
DIARRHOEA
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
DIZZINESS
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
DRY MOUTH
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
DYSGEUSIA
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
DYSPNOEA
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
ENCEPHALOPATHY
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
EYE SWELLING
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
FATIGUE
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
FEELING ABNORMAL
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
GENERAL PHYSICAL HEALTH DETERIORATION
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
GINGIVAL BLEEDING
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
HAEMODYNAMIC INSTABILITY
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
HAEMOLYTIC ANAEMIA
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
HEADACHE
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
HEPATIC ENCEPHALOPATHY
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
HEPATIC NEOPLASM MALIGNANT
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
HOSPITALISATION
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
HYPONATRAEMIA
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
HYPOTENSION
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
INCORRECT STORAGE OF DRUG
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
INFLUENZA LIKE ILLNESS
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
LARGE INTESTINE PERFORATION
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
LEUKOPENIA
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
LIP SWELLING
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
LOSS OF CONSCIOUSNESS
8
SS
PRODUCT USED FOR UNKNOWN INDICATION
LOSS OF LIBIDO
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
MOUTH HAEMORRHAGE
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
MULTI-ORGAN FAILURE
5
SS
PRODUCT USED FOR UNKNOWN INDICATION
MUSCULOSKELETAL PAIN
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
NAUSEA
7
SS
PRODUCT USED FOR UNKNOWN INDICATION
NEUTROPENIA
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
NO THERAPEUTIC RESPONSE
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
ORAL PAIN
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
OROPHARYNGEAL PAIN
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
PAIN
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
PHARYNGEAL HAEMORRHAGE
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
POST PROCEDURAL INFECTION
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
PRODUCT TASTE ABNORMAL
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
PROSTATITIS
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
PRURITUS
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
RASH
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
SKIN EXFOLIATION
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
STOMATITIS
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
SWELLING
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
SWOLLEN TONGUE
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
SYNCOPE
8
SS
PRODUCT USED FOR UNKNOWN INDICATION
THROMBOCYTOPENIA
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
TONGUE DRY
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
TONGUE HAEMORRHAGE
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
TUBERCULOSIS OF CENTRAL NERVOUS SYSTEM
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
URINARY INCONTINENCE
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
URINARY TRACT INFECTION
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
VOMITING
5
SS
PRODUCT USED FOR UNKNOWN INDICATION
WEIGHT DECREASED
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
WRONG TECHNIQUE IN DRUG USAGE PROCESS
6
SS
RENAL TRANSPLANT
ASTHENIA
1
SS
RENAL TRANSPLANT
BLOOD CREATININE INCREASED
1
SS
RENAL TRANSPLANT
C-REACTIVE PROTEIN INCREASED
1
SS
RENAL TRANSPLANT
HYPERTHERMIA
1
SS
RENAL TRANSPLANT
PANCYTOPENIA
1
C
ANAEMIA
ANGIOEDEMA
2
C
ANAEMIA
FACE OEDEMA
2
C
ANAEMIA
LIP OEDEMA
2
C
ANAEMIA
OSTEOMYELITIS
4
C
CHRONIC HEPATITIS
OSTEOMYELITIS
8
C
CHRONIC MYELOID LEUKAEMIA
DEATH
1
C
CRYOGLOBULINAEMIA
OSTEOMYELITIS
12
C
FACTOR VIII DEFICIENCY
HAEMORRHAGE
2
C
GASTRITIS
OSTEOMYELITIS
4
C
HEPATITIS C
ABDOMINAL DISTENSION
2
C
HEPATITIS C
ANAEMIA
3
C
HEPATITIS C
ANGIOEDEMA
2
C
HEPATITIS C
ANTINEUTROPHIL CYTOPLASMIC ANTIBODY INCREASED
3
C
HEPATITIS C
ASTHENIA
3
C
HEPATITIS C
BLOOD CREATININE INCREASED
3
C
HEPATITIS C
CONSTIPATION
5
C
HEPATITIS C
DIARRHOEA
1
C
HEPATITIS C
DIVERTICULITIS
3
C
HEPATITIS C
DYSPNOEA
1
C
HEPATITIS C
FACE OEDEMA
2
C
HEPATITIS C
FACIAL SPASM
1
C
HEPATITIS C
GASTRITIS
3
C
HEPATITIS C
GASTROOESOPHAGEAL REFLUX DISEASE
1
C
HEPATITIS C
HAEMORRHAGE
4
C
HEPATITIS C
HOSPITALISATION
3
C
HEPATITIS C
ILEUS PARALYTIC
5
C
HEPATITIS C
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
3
C
HEPATITIS C
INSOMNIA
1
C
HEPATITIS C
IRRITABILITY
1
C
HEPATITIS C
LIP OEDEMA
2
C
HEPATITIS C
MUSCLE SPASMS
1
C
HEPATITIS C
NO ADVERSE EVENT
1
C
HEPATITIS C
OEDEMA
3
C
HEPATITIS C
OSTEOMYELITIS
8
C
HEPATITIS C
RASH PRURITIC
3
C
HEPATITIS C
RETINAL HAEMORRHAGE
3
C
HEPATITIS C
SKIN SENSITISATION
1
C
HEPATITIS C
VITREOUS FLOATERS
5
C
HEPATITIS C VIRUS TEST POSITIVE
FACE OEDEMA
2
C
HEPATITIS C VIRUS TEST POSITIVE
HYPERTHERMIA
2
C
HEPATITIS C VIRUS TEST POSITIVE
RASH MACULO-PAPULAR
2
C
HYPERTENSION
BLOOD CREATININE INCREASED
1
C
HYPERTENSION
OSTEOMYELITIS
16
C
HYPERURICAEMIA
ANGIOEDEMA
2
C
HYPERURICAEMIA
FACE OEDEMA
2
C
HYPERURICAEMIA
LIP OEDEMA
2
C
ISCHAEMIC CARDIOMYOPATHY
ANGIOEDEMA
4
C
ISCHAEMIC CARDIOMYOPATHY
FACE OEDEMA
4
C
ISCHAEMIC CARDIOMYOPATHY
LIP OEDEMA
4
C
OSTEITIS
FACE OEDEMA
1
C
OSTEITIS
HYPERTHERMIA
1
C
OSTEITIS
RASH MACULO-PAPULAR
1
C
OSTEOMYELITIS
FACE OEDEMA
1
C
OSTEOMYELITIS
HYPERTHERMIA
1
C
OSTEOMYELITIS
RASH MACULO-PAPULAR
1
C
OSTEOPOROSIS
OSTEOMYELITIS
4
C
PAIN
HAEMORRHAGE
2
C
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
ANGIOEDEMA
2
C
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
FACE OEDEMA
2
C
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
LIP OEDEMA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
BLOOD CREATININE INCREASED
1
C
RENAL FAILURE
ANGIOEDEMA
2
C
RENAL FAILURE
FACE OEDEMA
2
C
RENAL FAILURE
LIP OEDEMA
2
C
THROMBOSIS PROPHYLAXIS
FACE OEDEMA
1
C
THROMBOSIS PROPHYLAXIS
HYPERTHERMIA
1
C
THROMBOSIS PROPHYLAXIS
RASH MACULO-PAPULAR
1
C
VARICES OESOPHAGEAL
FACE OEDEMA
1
C
VARICES OESOPHAGEAL
HYPERTHERMIA
1
C
VARICES OESOPHAGEAL
RASH MACULO-PAPULAR
1
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