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Index of reports
> Life Threatening Events (17)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Viramune (Nevirapine) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Viramune side effects in male
Reported by a physician from France on 2012-08-16
Patient: male
Reactions: Agitation, Urinary Incontinence, Coma, Coma Scale Abnormal, Pyrexia, Hepatotoxicity, Eye Movement Disorder, Hepatosplenomegaly, Anaemia, Malnutrition, General Physical Health Deterioration, Encephalopathy, Faecal Incontinence, Convulsion, Respiratory Tract Congestion, Apathy, Depressed Level of Consciousness, Nervous System Disorder, Confusional State, Immune Reconstitution Syndrome, Snoring, Hepatitis Cholestatic, Intracranial Pressure Increased, Hepatic Ischaemia, Thrombocytopenia, Oxygen Saturation Decreased, Refusal of Treatment by Patient, Necrotising Granulomatous Lymphadenitis, Hepatic Fibrosis, Mycobacterial Infection, Hyponatraemia, Cerebral Atrophy, White Blood Cell Disorder, Renal Failure, Hypoproteinaemia, Diarrhoea, Brain Abscess, Heart Rate Increased, Encephalitic Infection, Heart Sounds Abnormal
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Bactrim
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Olanzapine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-01
Clarithromycin
Dosage: df 50mg/ml
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Nefopam
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Prazepam
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Truvada
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-01
Viramune
Indication: HIV Infection
Start date: 2012-03-01
End date: 2012-05-01
Myambutol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Amikacin
Dosage: 900 mg daily
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Cernevit-12
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Rifabutin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Folic Acid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Kaletra
Dosage: df 80/20 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-01
Perikabiven (Parenteral Nutrition)
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Isentress
Administration route: Oral
Indication: HIV Infection
Start date: 2012-05-01
Potassium Chloride
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Acetaminophen
Dosage: df 10mg/ml
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Other drugs received by patient: Propofol; Adavat
Possible Viramune side effects in male
Reported by a physician from France on 2012-08-15
Patient: male
Reactions: Agitation, Urinary Incontinence, Coma, Pyrexia, Coma Scale Abnormal, Hepatotoxicity, Eye Movement Disorder, Hepatosplenomegaly, Anaemia, Malnutrition, Encephalopathy, Faecal Incontinence, General Physical Health Deterioration, Convulsion, Apathy, Respiratory Tract Congestion, Depressed Level of Consciousness, Nervous System Disorder, Confusional State, Immune Reconstitution Syndrome, Snoring, Hepatitis Cholestatic, Intracranial Pressure Increased, Hepatic Ischaemia, Thrombocytopenia, Oxygen Saturation Decreased, Refusal of Treatment by Patient, Necrotising Granulomatous Lymphadenitis, Hepatic Fibrosis, Mycobacterial Infection, Cerebral Atrophy, Hyponatraemia, Renal Failure, White Blood Cell Disorder, Diarrhoea, Hypoproteinaemia, Heart Rate Increased, Brain Abscess, Encephalitic Infection, Heart Sounds Abnormal
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Olanzapine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-01
Clarithromycin
Dosage: df 50mg/ml
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Bactrim
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
Amikacin
Dosage: 900 mg daily
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Acetaminophen
Dosage: df 10mg/ml
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
Perikabiven (Parenteral Nutrition)
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
Rifabutin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Cernevit-12
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Nefopam
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Viramune
Indication: HIV Infection
Start date: 2012-03-01
End date: 2012-05-01
Myambutol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Potassium Chloride
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
Folic Acid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
Isentress
Administration route: Oral
Indication: HIV Infection
Start date: 2012-05-01
Kaletra
Dosage: df 80/20 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-01
Prazepam
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
Truvada
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-01
Other drugs received by patient: Adavat; Propofol
Possible Viramune side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-04-23
Patient: 40 year old female
Reactions: Jaundice, Hepatic Encephalopathy, Vomiting, Nausea, Oliguria, Coagulopathy, Hypoglycaemia, Acute Hepatic Failure, Pyrexia, Decreased Appetite
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Truvada
Administration route: Oral
Indication: HIV Infection
Start date: 2009-02-01
End date: 2010-07-29
Viramune
Administration route: Oral
Indication: HIV Infection
Start date: 2010-06-01
End date: 2010-07-29
Other drugs received by patient: Alprazolam; Zolpidem Tartrate; Temazepam; Atarax
Possible Viramune side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-04-13
Patient: 40 year old female
Reactions: Jaundice, Vomiting, Nausea, Coagulopathy, Hypoglycaemia, Pyrexia, Hepatic Encephalopathy, Oliguria, Acute Hepatic Failure, Decreased Appetite
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Viramune
Administration route: Oral
Indication: HIV Infection
Start date: 2010-06-01
End date: 2010-07-29
Truvada
Administration route: Oral
Indication: HIV Infection
Start date: 2009-02-01
End date: 2010-07-29
Other drugs received by patient: Atarax; Temazepam; Zolpidem Tartrate; Alprazolam
Possible Viramune side effects in male
Reported by a physician from India on 2012-03-16
Patient: male, weighing 49.5 kg (108.9 pounds)
Reactions: Pancytopenia
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Zidovudine
Administration route: Oral
Indication: HIV Infection
Start date: 2012-01-05
End date: 2012-02-28
Viramune
Dosage: 400 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2012-01-06
End date: 2012-02-28
Other drugs received by patient: Norfloxacin; Domperidone; Oral Rehydration Solution; Disodium Hydrogen Citrate; Omeprazole; Lamivudine + Zidovudine
Possible Viramune side effects in male
Reported by a physician from India on 2012-03-15
Patient: male, weighing 49.5 kg (108.9 pounds)
Reactions: Pancytopenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Viramune
Dosage: 400 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2012-01-06
End date: 2012-02-24
Zidovudine
Administration route: Oral
Indication: HIV Infection
Start date: 2012-01-05
End date: 2012-02-24
Other drugs received by patient: Oral Rehydration Solution; Disodium Hydrogen Citrate; Domperidone; Omeprazole; Lamivudine + Zidovudine; Norfloxacin
Possible Viramune side effects in male
Reported by a physician from India on 2012-03-08
Patient: male, weighing 49.5 kg (108.9 pounds)
Reactions: Urinary Tract Infection, Sepsis, Pleural Effusion, Pancytopenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Viramune
Dosage: 400 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2012-01-06
End date: 2012-02-24
Zidovudine
Administration route: Oral
Indication: HIV Infection
Start date: 2012-01-05
End date: 2012-02-24
Other drugs received by patient: Disodium Hydrogen Citrate; Domperidone; Oral Rehydration Solution; Norfloxacin; Omeprazole
Possible Viramune side effects in male
Reported by a physician from India on 2012-03-05
Patient: male, weighing 49.5 kg (108.9 pounds)
Reactions: Sepsis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Viramune
Dosage: 400 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2012-01-06
End date: 2012-02-24
Zidovudine
Dosage: 600 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2012-01-05
End date: 2012-02-24
Other drugs received by patient: Norfloxacin; Omeprazole; Oral Rehydration Solution; Domperidone; Disodium Hydrogen Citrate
Possible Viramune side effects in female
Reported by a physician from Zimbabwe on 2012-01-23
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Abdominal Pain, Lactic Acidosis, Treatment Noncompliance, Blood Sodium Decreased, Diabetes Mellitus Inadequate Control, Cough, Vomiting, Pneumonia, Dyspnoea, Blood Chloride Decreased, Hyperglycaemia, Blood Glucose Decreased, Aspartate Aminotransferase Increased, Platelet Count Decreased, Diabetic Ketoacidosis, Asthenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lamivudine
Dosage: 300 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-17
End date: 2011-05-10
Lamivudine
Dosage: 300 mg
Administration route: Oral
Start date: 2011-06-27
Viramune
Dosage: 400 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-17
End date: 2011-05-10
Metformin HCL
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2011-02-01
End date: 2011-05-10
Viramune
Dosage: 400 mg
Administration route: Oral
Start date: 2011-06-27
Stavudine
Dosage: 60 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-09
End date: 2011-05-10
Other drugs received by patient: Cotrim; TDF; Albuterol Sulfate Autohaler
Possible Viramune side effects in female
Reported by a physician from Zimbabwe on 2012-01-17
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Hyperglycaemia, Diabetic Ketoacidosis, Lactic Acidosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Viramune
Dosage: 400 mg
Administration route: Oral
Start date: 2011-06-27
Lamivudine
Dosage: 300 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-17
End date: 2011-05-10
Stavudine
Dosage: 60 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-09
End date: 2011-05-10
Metformin HCL
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2011-02-01
End date: 2011-05-10
Viramune
Dosage: 400 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-17
End date: 2011-05-10
Lamivudine
Dosage: 300 mg
Administration route: Oral
Start date: 2011-06-27
Other drugs received by patient: Albuterol Sulfate Autohaler; TDF; Cotrim
Possible Viramune side effects in female
Reported by a physician from Zimbabwe on 2012-01-13
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Abdominal Pain, Pneumonia, Hyperglycaemia, Dehydration, Diabetic Ketoacidosis, Lactic Acidosis, Diabetes Mellitus Inadequate Control
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lamivudine
Dosage: 300 mg
Administration route: Oral
Start date: 2011-06-27
Metformin HCL
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2011-02-01
End date: 2011-05-10
Viramune
Dosage: 400 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-17
End date: 2011-05-10
Viramune
Dosage: 400 mg
Administration route: Oral
Start date: 2011-06-27
Stavudine
Dosage: 60 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-09
End date: 2011-05-10
Lamivudine
Dosage: 300 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-17
End date: 2011-05-10
Other drugs received by patient: Cotrim; TDF; Albuterol Sulfate Autohaler
Possible Viramune side effects in female
Reported by a physician from France on 2011-12-23
Patient: female, weighing 64.0 kg (140.8 pounds)
Reactions: Hepatic Encephalopathy, Hepatic Failure, Liver Transplant, Hepatitis Fulminant
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Viramune
Other drugs received by patient: Combivir; Acetaminophen; Quinimax; Zyrtec; Ofloxacin; Coartem; Quinimax
Possible Viramune side effects in male
Reported by a physician from India on 2011-12-12
Patient: male, weighing 47.0 kg (103.4 pounds)
Reactions: Suicide Attempt, Suicidal Ideation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Viramune
Dosage: 200 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-01-20
Viramune
Dosage: 400 mg
Administration route: Oral
Start date: 2011-02-03
Emtricitabine / Tenofovir Disoproxil Fumarate
Dosage: 200 mg/300 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-01-20
Other drugs received by patient: Acetaminophen; Multi-Vitamin
Possible Viramune side effects in male
Reported by a physician from India on 2011-12-02
Patient: male, weighing 47.0 kg (103.4 pounds)
Reactions: Suicide Attempt, Suicidal Ideation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Emtricitabine / Tenofovir Disoproxil Fumarate
Dosage: 200 mg/300 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-01-20
Viramune
Dosage: 200 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-01-20
Viramune
Dosage: 400 mg
Administration route: Oral
Start date: 2011-02-03
Other drugs received by patient: Multi-Vitamin; Acetaminophen
Possible Viramune side effects in male
Reported by a physician from India on 2011-11-23
Patient: male, weighing 47.0 kg (103.4 pounds)
Reactions: Suicide Attempt, Suicidal Ideation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Viramune
Dosage: 200 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-01-20
Emtricitabine / Tenofovir Disoproxil Fumarate
Dosage: 200 mg/300 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-01-20
Viramune
Dosage: 400 mg
Administration route: Oral
Start date: 2011-02-03
Other drugs received by patient: Multi-Vitamin; Acetaminophen
Possible Viramune side effects in male
Reported by a physician from India on 2011-11-21
Patient: male, weighing 47.0 kg (103.4 pounds)
Reactions: Suicide Attempt, Suicidal Ideation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Emtricitabine / Tenofovir Disoproxil Fumarate
Dosage: 200 mg/300 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-01-20
Viramune
Dosage: 200 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-01-20
Viramune
Dosage: 400 mg
Administration route: Oral
Start date: 2011-02-03
Other drugs received by patient: Multi-Vitamin; Acetaminophen
Possible Viramune side effects in male
Reported by a physician from India on 2011-11-14
Patient: male, weighing 47.0 kg (103.4 pounds)
Reactions: Suicide Attempt, Suicidal Ideation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Emtricitabine / Tenofovir Disoproxil Fumarate
Dosage: 200 mg/300 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-01-20
Viramune
Dosage: 200 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-01-20
Viramune
Dosage: 400 mg
Administration route: Oral
Start date: 2011-02-03
Other drugs received by patient: Multi-Vitamin; Acetaminophen
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