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Viramune (Nevirapine) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



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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