Index of reports
> Serious Reactions (71)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Viramune (Nevirapine) serious reactions. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 71 Next >>
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 2012-08-16
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 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 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 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 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 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 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 29 year old female
Reported by a physician from United Kingdom on 2012-07-18
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 29 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-18
Patient: 29 year old female
Reactions: Maternal Exposure During Pregnancy, Abortion Induced
Drug(s) suspected as cause:
Epzicom
Dosage: 1tab per day
Administration route: Oral
Indication: HIV Infection
Start date: 2010-12-13
Viramune
Dosage: 400mgd per day
Administration route: Oral
Indication: HIV Infection
Possible Viramune side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-18
Patient: female
Reactions: Neural Tube Defect, Spina Bifida, Arnold-Chiari Malformation, Meningomyelocele, Cerebral Ventricle Dilatation
Drug(s) suspected as cause:
Viramune
Other drugs received by patient: Epzicom
Possible Viramune side effects in male
Reported by a physician from Germany on 2012-07-10
Patient: male
Reactions: Nausea, Angina Pectoris, Hypotension, Rash, Pyrexia, Abdominal Discomfort, Malaise, Suicide Attempt, Blood Creatinine Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ibuprofen
Dosage: unkown amount
Administration route: Oral
Viramune
Dosage: 40 anz
Administration route: Oral
Possible Viramune side effects in male
Reported by a physician from Italy on 2012-07-06
Patient: male
Reactions: Somnolence, Hallucination
Drug(s) suspected as cause:
Truvada
Dosage: 1 df, qd
Administration route: Oral
Indication: HIV Infection
Start date: 2010-10-21
End date: 2012-06-18
Viramune
Dosage: unk
Indication: Antiretroviral Therapy
Start date: 2010-10-21
End date: 2012-06-18
Other drugs received by patient: Gabapentin; Arcoxia; Amitriptyline HCL; Alfuzosin HCL; Entumin
Possible Viramune side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-05
Patient: male
Reactions: Mixed Liver Injury
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Indication: Cardiovascular Event Prophylaxis
Start date: 2009-03-01
End date: 2011-12-23
Viramune
Dosage: 400 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-12-01
End date: 2011-12-23
Other drugs received by patient: Norvir; Diltiazem HCL; Kardegic; Truvada
Possible Viramune side effects in male
Reported by a physician from France on 2012-07-05
Patient: male
Reactions: Renal Colic, Mixed Liver Injury
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Indication: Cardiovascular Event Prophylaxis
Start date: 2009-03-01
End date: 2011-12-23
Viramune
Administration route: Oral
Indication: HIV Infection
Start date: 2011-12-01
End date: 2011-12-23
Other drugs received by patient: Kardegic; Truvada; Diltiazem HCL
Possible Viramune side effects in
Reported by a physician from United Kingdom on 2012-06-29
Patient:
Reactions: Neural Tube Defect, Foetal Exposure During Pregnancy, Cerebral Ventricle Dilatation, Meningomyelocele
Drug(s) suspected as cause:
Viramune
Other drugs received by patient: Epzicom
Possible Viramune side effects in 41 year old male
Reported by a physician from United Kingdom on 2012-06-05
Patient: 41 year old male, weighing 62.5 kg (137.5 pounds)
Reactions: Rash Generalised, Vomiting, Swelling Face, Mouth Ulceration, Tachycardia, Pyrexia, Plantar Fasciitis, Diarrhoea, Paraneoplastic Pemphigus, Abdominal Distension, Treponema Test Positive, Lymphoma, Stevens-Johnson Syndrome
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Viramune
Other drugs received by patient: Antobiotics; Lots OF Medications
Possible Viramune side effects in 38 year old female
Reported by a pharmacist from United Kingdom on 2012-06-05
Patient: 38 year old female
Reactions: Maternal Exposure During Pregnancy, Anaemia Haemolytic Autoimmune
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kyvexa
Dosage: 1 anz
Administration route: Oral
Indication: HIV Infection
Start date: 2009-10-01
End date: 2012-04-28
Viramune
Dosage: 400 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-11-15
End date: 2012-04-28
Other drugs received by patient: Folic Acid; Iron; Calceos
Possible Viramune side effects in
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-22
Patient:
Reactions: Neural Tube Defect, Meningomyelocele, Cerebral Ventricle Dilatation
Drug(s) suspected as cause:
Viramune
Other drugs received by patient: Epzicom
Possible Viramune side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-09
Patient: male, weighing 2.0 kg (4.4 pounds)
Reactions: Ultrasound Antenatal Screen, LOW Birth Weight Baby, Trisomy 21, Congenital Bowing of Long Bones, Premature Baby, Ventricular Septal Defect
Drug(s) suspected as cause:
Viramune
Other drugs received by patient: Zerit; Combivir; Epivir; Retrovir
Possible Viramune side effects in 38 year old female
Reported by a pharmacist from United Kingdom on 2012-05-08
Patient: 38 year old female
Reactions: Maternal Exposure During Pregnancy, Anaemia Haemolytic Autoimmune, Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kyvexa
Dosage: 1 anz
Indication: HIV Infection
Viramune
Dosage: 400 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2011-11-15
End date: 2012-04-28
Other drugs received by patient: Caseos; Iron; Folic Acid
Possible Viramune side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-25
Patient: male, weighing 2.0 kg (4.4 pounds)
Reactions: Ultrasound Antenatal Screen, LOW Birth Weight Baby, Trisomy 21, Congenital Bowing of Long Bones, Premature Baby, Ventricular Septal Defect
Drug(s) suspected as cause:
Viramune
Other drugs received by patient: Zerit; Retrovir; Combivir; Epivir
Possible Viramune side effects in male
Reported by a consumer/non-health professional from United Kingdom on 2012-04-24
Patient: male, weighing 88.0 kg (193.6 pounds)
Reactions: Nightmare, Drug Interaction, Drug Withdrawal Syndrome, Serotonin Syndrome, Tremor, Suicidal Ideation, Mania, Anxiety, Hallucination
Drug(s) suspected as cause:
Viramune
Other drugs received by patient: Acetaminophen and Codeine Phosphate; Truvada
Possible Viramune side effects in 70 year old
Reported by a consumer/non-health professional from United Kingdom on 2012-03-22
Patient: 70 year old
Reactions: Nightmare, Drug Interaction, Drug Withdrawal Syndrome, Serotonin Syndrome, Tremor, Suicidal Ideation, Anxiety, Hallucination
Drug(s) suspected as cause:
Viramune
Dosage: 200 mg
Indication: HIV Infection
Viramune
Dosage: 400 mg
Start date: 2012-01-01
Other drugs received by patient: Paroxetine HCL; Truvada
Possible Viramune side effects in male
Reported by a physician from Germany on 2012-03-22
Patient: male
Reactions: Suicide Attempt
Drug(s) suspected as cause:
Prezista
Dosage: rt: 10-20 tabletten
Administration route: Oral
Start date: 2012-03-10
Viramune
Dosage: rt: 18-40 tabletten
Administration route: Oral
Start date: 2012-03-10
Possible Viramune side effects in male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-19
Patient: male
Reactions: Suicide Attempt, Multiple Drug Overdose Intentional
Drug(s) suspected as cause:
Prezista
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-03-10
End date: 2012-03-10
Viramune
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-03-10
End date: 2012-03-10
Possible Viramune side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-08
Patient: female
Reactions: Optic Nerve Disorder, Glaucoma, Colour Blindness Acquired
Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
Dosage: 1 anz
Administration route: Oral
Indication: HIV Infection
Viramune
Dosage: 400 mg
Administration route: Oral
Indication: HIV Infection
Other drugs received by patient: EYE Drops
Possible Viramune side effects in 32 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-07
Patient: 32 year old female
Reactions: Placenta Praevia
Drug(s) suspected as cause:
Viramune
Other drugs received by patient: Tenofovir Disoproxil Fumarate+emtrictabine; Zidovudine (Retrovir, Zdv)
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