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Viramune (Nevirapine) - Serious Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Serious Events (137)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Viramune (Nevirapine) serious events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 137   Next >>

Possible Viramune side effects in male

Reported by a physician from United Kingdom on 2012-08-24

Patient: male, weighing 3.1 kg (6.8 pounds)

Reactions: Intestinal Malrotation

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Lamivudine; Zidovudine; Raltegravir; Lopinavir and Ritonavir; Tenofovir Disoproxil Fumarate



Possible Viramune side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient:

Reactions: Cholestasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epivir
    Dosage: 150 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-22
    End date: 2012-06-12

Isentress
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-22
    End date: 2012-06-12

Viramune
    Dosage: 200 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-22
    End date: 2012-06-12



Possible Viramune side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male, weighing 2.0 kg (4.4 pounds)

Reactions: LOW Birth Weight Baby, Trisomy 21, Ultrasound Antenatal Screen, Premature Baby, Congenital Bowing of Long Bones, Ventricular Septal Defect

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Combivir; Zerit; Retrovir; Epivir; Retrovir



Possible Viramune side effects in male

Reported by a physician from France on 2012-08-20

Patient: male

Reactions: Pruritus, Malaise, Rash Generalised, Hepatocellular Injury, Cholestasis, Chromaturia, Faeces Discoloured

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epivir
    Dosage: 150mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-22
    End date: 2012-06-12

Isentress
    Dosage: 400mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-22
    End date: 2012-06-12

Viramune
    Dosage: 200mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-22
    End date: 2012-06-12



Possible Viramune side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: male, weighing 2.0 kg (4.4 pounds)

Reactions: Trisomy 21, Premature Baby, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Limb Malformation, Acoustic Stimulation Tests Abnormal

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-15

Epivir
    Dosage: 300mgd per day
    Indication: Antiretroviral Therapy
    End date: 2011-07-15

Retrovir
    Dosage: 2mgkh per day
    Indication: Antiretroviral Therapy
    Start date: 2011-10-07
    End date: 2011-10-07

Viramune
    Dosage: 400mgd per day
    Indication: Antiretroviral Therapy

Zerit
    Dosage: 40mgd per day
    Indication: Antiretroviral Therapy
    End date: 2011-07-15



Possible Viramune side effects in male

Reported by a physician from United Kingdom on 2012-08-17

Patient: male, weighing 3.1 kg (6.8 pounds)

Reactions: Intestinal Malrotation

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Lamivudine; Lopinavir and Ritonavir; Zidovudine; Tenofovir Disoproxil Fumarate; Raltegravir



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:
Acetaminophen
    Dosage: df 10mg/ml
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Amikacin
    Dosage: 900 mg daily
    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
    End date: 2012-07-16

Cernevit-12
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Clarithromycin
    Dosage: df 50mg/ml
    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

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

Myambutol
    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

Olanzapine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Perikabiven (Parenteral Nutrition)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Potassium Chloride
    Administration route: Oral
    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

Rifabutin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

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

Other drugs received by patient: Propofol; Adavat



Possible Viramune side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-15

Patient: male

Reactions: Cholestasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epivir
    Dosage: 150 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-22
    End date: 2012-06-12

Isentress
    Dosage: 800 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-22
    End date: 2012-06-12

Viramune
    Dosage: 400 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-22
    End date: 2012-06-12



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:
Acetaminophen
    Dosage: df 10mg/ml
    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

Bactrim
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Cernevit-12
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Clarithromycin
    Dosage: df 50mg/ml
    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

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

Myambutol
    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

Olanzapine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Perikabiven (Parenteral Nutrition)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Potassium Chloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Prazepam
    Administration route: Oral
    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

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

Other drugs received by patient: Adavat; Propofol



Possible Viramune side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient:

Reactions: Congenital Cystic Kidney Disease

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Combivir; Retrovir



Possible Viramune side effects in female

Reported by a health professional (non-physician/pharmacist) from South Africa on 2012-08-09

Patient: female, weighing 3.3 kg (7.3 pounds)

Reactions: Tooth Disorder

Drug(s) suspected as cause:
Combivir
    Indication: Vertical Infection Transmission
    Start date: 2005-03-01

Efavirenz
    Indication: Vertical Infection Transmission
    Start date: 2005-03-01

Viramune
    Indication: Vertical Infection Transmission
    Start date: 2009-02-27



Possible Viramune side effects in female

Reported by a physician from United Kingdom on 2012-08-08

Patient: female

Reactions: Neural Tube Defect, Spina Bifida, Arnold-Chiari Malformation, Cerebral Ventricle Dilatation, Meningomyelocele

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Epzicom



Possible Viramune side effects in 29 year old female

Reported by a physician from United Kingdom on 2012-08-08

Patient: 29 year old female

Reactions: Abortion Induced

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Epzicom



Possible Viramune side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08

Patient:

Reactions: Congenital Cystic Kidney Disease

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Combivir; Retrovir



Possible Viramune side effects in 52 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-03

Patient: 52 year old female

Reactions: Hypersensitivity, Rash Generalised, Glomerular Filtration Rate Decreased, Alanine Aminotransferase Increased, Pyrexia, Myalgia, Malaise, Arthralgia, Liver Function Test Abnormal, Blood Creatinine Increased, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Abacavir Sulfate / Lamivudine



Possible Viramune side effects in male

Reported by a physician from United States on 2012-08-01

Patient: male, weighing 2.0 kg (4.4 pounds)

Reactions: Trisomy 21, Ultrasound Antenatal Screen, LOW Birth Weight Baby, Maternal Drugs Affecting Foetus, Premature Baby, Congenital Bowing of Long Bones, Ventricular Septal Defect

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Retrovir; Combivir; Zerit; Retrovir; Epivir



Possible Viramune side effects in male

Reported by a physician from South Africa on 2012-07-31

Patient: male, weighing 2.9 kg (6.3 pounds)

Reactions: Rectal Haemorrhage, Neonatal Asphyxia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Viramune
    Indication: Prophylaxis Against HIV Infection
    Start date: 2012-06-25
    End date: 2012-06-25

Viramune
    Dosage: 1.5 ml
    Administration route: Oral
    Indication: Prophylaxis Against HIV Infection
    Start date: 2012-06-26

Other drugs received by patient: Emtricitabine / Tenofovir Disoproxil Fumarate; Zidovudine



Possible Viramune side effects in female

Reported by a physician from South Africa on 2012-07-31

Patient: female, weighing 3.3 kg (7.3 pounds)

Reactions: Tooth Disorder

Drug(s) suspected as cause:
Combivir
    Indication: Vertical Infection Transmission
    Start date: 2005-03-01

Efavirenz (Stocrin, Efv)
    Indication: Vertical Infection Transmission
    Start date: 2005-03-01

Viramune
    Indication: Vertical Infection Transmission
    Start date: 2009-02-27



Possible Viramune side effects in male

Reported by a physician from United States on 2012-07-30

Patient: male, weighing 2.0 kg (4.4 pounds)

Reactions: Trisomy 21, Premature Baby, Foetal Exposure During Pregnancy, Limb Malformation

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-15

Epivir
    Dosage: 300mgd per day
    Indication: Antiretroviral Therapy
    End date: 2011-07-15

Retrovir
    Dosage: 2mgkh per day
    Indication: Antiretroviral Therapy
    Start date: 2011-10-07
    End date: 2011-10-07

Viramune
    Dosage: 400mgd per day
    Indication: Antiretroviral Therapy

Zerit
    Dosage: 40mgd per day
    Indication: Antiretroviral Therapy
    End date: 2011-07-15



Possible Viramune side effects in

Reported by a physician from United States on 2012-07-27

Patient:

Reactions: Congenital Cystic Kidney Disease

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Retrovir; Combivir



Possible Viramune side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-27

Patient: female

Reactions: Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Truvada
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-01-21
    End date: 2012-02-13

Viramune
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-21
    End date: 2012-02-04

Viramune
    Dosage: 2 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-05
    End date: 2012-02-13

Other drugs received by patient: Kaletra; Viread



Possible Viramune side effects in

Reported by a physician from Portugal on 2012-07-27

Patient:

Reactions: Polyhydramnios

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Truvada; Combivir; Truvada



Possible Viramune side effects in male

Reported by a physician from Germany on 2012-07-27

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Abdominal Discomfort, Malaise, Nausea, Angina Pectoris, Hypotension, Suicide Attempt, Pyrexia, Rash, Blood Creatinine Increased, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ibuprofen
    Dosage: 20 anz
    Administration route: Oral

Viramune
    Dosage: 40 anz
    Administration route: Oral



Possible Viramune side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-26

Patient: female

Reactions: Mouth Ulceration, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Truvada
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-01-01
    End date: 2012-05-07

Viramune
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2012-04-10
    End date: 2012-04-25

Viramune
    Dosage: 2 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-04-26
    End date: 2012-05-07

Other drugs received by patient: Norvir; Reyataz



Possible Viramune side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24

Patient: male, weighing 2.0 kg (4.4 pounds)

Reactions: LOW Birth Weight Baby, Trisomy 21, Ultrasound Antenatal Screen, Congenital Bowing of Long Bones, Premature Baby, Ventricular Septal Defect

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Epivir; Combivir; Zerit; Retrovir; Retrovir



Possible Viramune side effects in male

Reported by a physician from South Africa on 2012-07-24

Patient: male, weighing 2.9 kg (6.3 pounds)

Reactions: Rectal Haemorrhage, Neonatal Asphyxia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Viramune
    Dosage: 1.5 ml
    Administration route: Oral
    Indication: Prophylaxis Against HIV Infection
    Start date: 2012-06-26

Viramune
    Indication: Prophylaxis Against HIV Infection
    Start date: 2012-06-25
    End date: 2012-06-25

Other drugs received by patient: Emtricitabine / Tenofovir Disoproxil Fumarate; Zidovudine



Possible Viramune side effects in male

Reported by a physician from South Africa on 2012-07-20

Patient: male, weighing 2.9 kg (6.3 pounds)

Reactions: Rectal Haemorrhage, Neonatal Asphyxia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Viramune
    Dosage: 1.5 ml
    Administration route: Oral
    Indication: Prophylaxis Against HIV Infection
    Start date: 2012-06-26

Viramune
    Indication: Prophylaxis Against HIV Infection
    Start date: 2012-06-25
    End date: 2012-06-25

Other drugs received by patient: Zidovudine; Emtricitabine / Tenofovir Disoproxil Fumarate



Possible Viramune side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-20

Patient: female

Reactions: Lipodystrophy Acquired

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-03-04

Viramune
    Dosage: 400 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-03-15



Possible Viramune side effects in

Reported by a physician from Portugal on 2012-07-19

Patient:

Reactions: Polyhydramnios

Drug(s) suspected as cause:
Viramune

Other drugs received by patient: Combivir; Truvada; Truvada



Possible Viramune side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-18

Patient: female, weighing 0.4 kg (0.9 pounds)

Reactions: Neural Tube Defect, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Cerebral Ventricle Dilatation, Meningomyelocele

Drug(s) suspected as cause:
Epzicom
    Dosage: 1tab per day
    Indication: HIV Infection
    Start date: 2010-12-13

Viramune
    Dosage: 400mgd per day
    Indication: HIV Infection



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