This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Viramune (Nevirapine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (168)
Death (6)
Life Threatening Events (17)
Reports by Reaction Type
Pyrexia (20),
Rash (15),
Premature Baby (14),
Viral Load Increased (10),
Diarrhoea (10),
Suicide Attempt (9),
LOW Birth Weight Baby (8),
Foetal Exposure During Pregnancy (8),
Trisomy 21 (8),
Abortion Spontaneous (7),
Suicidal Ideation (7),
Malaise (7)
Below are a few examples of reports where side effects / adverse reactions may be related to Viramune (Nevirapine). For a complete list or a specific selection of reports, please use the links above.
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
Reported by a pharmacist from United States on 2012-08-23
Patient:
Reactions: Viral Load Increased
Drug(s) suspected as cause:
Viramune
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
Reported by a physician from United States on 2012-08-10
Patient:
Reactions: Medication Residue
Drug(s) suspected as cause:
Viramune
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 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 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 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 2012-08-03
Patient: male
Reactions: Swelling Face, Cellulitis, Rash, Face Injury
Drug(s) suspected as cause:
Viramune
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 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 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 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 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
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 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
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