This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Viracept (Nelfinavir) 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 (20)
Death (1)
Reports by Reaction Type
Maternal Drugs Affecting Foetus (6),
Lipodystrophy Acquired (3),
Premature Baby (3),
Maternal Exposure During Pregnancy (3),
Maternal Exposure Timing Unspecified (3),
Ileal Atresia (3),
Foetal Exposure During Pregnancy (2),
Pulmonary Embolism (2),
Autoimmune Thyroiditis (2),
Live Birth (2),
Myocardial Infarction (2),
Sickle Cell Anaemia (2)
Possible Viracept side effects in female
Reported by a consumer/non-health professional from France on 2012-06-20
Patient: female
Reactions: Nervous System Disorder, Sjogren's Syndrome, Autoimmune Thyroiditis
Drug(s) suspected as cause:
Viracept
Possible Viracept side effects in 44 year old male
Reported by a consumer/non-health professional from France on 2012-06-18
Patient: 44 year old male
Reactions: Pulmonary Embolism, Lipodystrophy Acquired, Myocardial Infarction
Drug(s) suspected as cause:
Viracept
Administration route: Oral
Indication: HIV Infection
Start date: 1998-06-15
End date: 1999-01-22
Sustiva
Administration route: Oral
Indication: HIV Infection
Start date: 1998-06-15
Possible Viracept side effects in 44 year old male
Reported by a consumer/non-health professional from France on 2012-05-23
Patient: 44 year old male
Reactions: Pulmonary Embolism, Myocardial Infarction, Lipodystrophy Acquired
Drug(s) suspected as cause:
Sustiva
Administration route: Oral
Indication: HIV Infection
Start date: 1998-06-15
Viracept
Administration route: Oral
Indication: HIV Infection
Start date: 1998-06-15
End date: 1999-01-22
Possible Viracept side effects in 44 year old male
Reported by a physician from France on 2012-05-18
Patient: 44 year old male
Reactions: Lipodystrophy Acquired
Drug(s) suspected as cause:
Sustiva
Dosage: unk
Administration route: Oral
Indication: HIV Test Positive
Start date: 1998-06-15
Viracept
Dosage: unk
Administration route: Oral
Indication: HIV Test Positive
Start date: 1998-06-15
End date: 1999-01-22
Possible Viracept side effects in female
Reported by a consumer/non-health professional from France on 2012-04-13
Patient: female
Reactions: Nervous System Disorder, Sjogren's Syndrome, Autoimmune Thyroiditis
Drug(s) suspected as cause:
Viracept
Possible Viracept side effects in
Reported by a individual with unspecified qualification from Netherlands on 2012-03-21
Patient:
Reactions: Diarrhoea, Postoperative Wound Complication, Cholangitis, Transaminases Increased
Drug(s) suspected as cause:
Viracept
Indication: Rectal Cancer
Xeloda
Indication: Rectal Cancer
Possible Viracept side effects in 6 month old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-07
Patient: 6 month old female, weighing 3.1 kg (6.8 pounds)
Reactions: Blood Lactate Dehydrogenase Increased, Lactic Acidosis, Maternal Exposure Timing Unspecified, Blood Lactic Acid Increased, Arthropathy, Neuropathy Peripheral, Laboratory Test Abnormal, Connective Tissue Disorder, Neutropenia, Congenital Cystic Kidney Disease, Hypertriglyceridaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zidovudine
Zidovudine
Indication: HIV Infection
Stavudine
Dosage: 30 mg, 2x/day
Administration route: Oral
Indication: HIV Infection
Viracept
Stavudine
Viracept
Dosage: 1250 mg, 2x/day
Administration route: Oral
Indication: HIV Infection
Videx
Dosage: 250 mg daily
Administration route: Oral
Indication: HIV Infection
Videx
Possible Viracept side effects in
Reported by a physician from United States on 2012-02-21
Patient: , weighing 2.4 kg (5.3 pounds)
Reactions: Ileal Atresia, Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Stavudine
Dosage: 80mgd per day
Indication: Antiretroviral Therapy
Viracept
Dosage: 1250mgd per day
Indication: Antiretroviral Therapy
Epivir
Dosage: 300mgd per day
Indication: Antiretroviral Therapy
Possible Viracept side effects in 41 year old female
Reported by a physician from United States on 2012-02-21
Patient: 41 year old female
Reactions: Live Birth, Maternal Exposure During Pregnancy, Premature Delivery
Drug(s) suspected as cause:
Epivir
Dosage: 300mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Stavudine
Dosage: 80mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Viracept
Dosage: 1250mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Possible Viracept side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-08
Patient: , weighing 2.4 kg (5.2 pounds)
Reactions: Maternal Drugs Affecting Foetus, Ileal Atresia
Drug(s) suspected as cause:
Viracept
Dosage: (1250 mg, 1 d), transplacental
Indication: Antiretroviral Therapy
Stavudine
Dosage: (80 mg, 1 d), transdermal
Indication: Antiretroviral Therapy
Epivir
Dosage: (300 mg, 1 d), transplacental
Indication: Antiretroviral Therapy
Possible Viracept side effects in
Reported by a physician from United States on 2012-02-06
Patient: , weighing 2.4 kg (5.3 pounds)
Reactions: Ileal Atresia, Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Epivir
Dosage: 300mgd per day
Indication: Antiretroviral Therapy
Stavudine
Dosage: 80mgd per day
Indication: Antiretroviral Therapy
Viracept
Dosage: 1250mgd per day
Indication: Antiretroviral Therapy
Possible Viracept side effects in 41 year old female
Reported by a physician from United States on 2012-02-06
Patient: 41 year old female
Reactions: Maternal Exposure During Pregnancy, Live Birth, Premature Delivery
Drug(s) suspected as cause:
Stavudine
Dosage: 80mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Viracept
Dosage: 1250mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Epivir
Dosage: 300mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Possible Viracept side effects in male
Reported by a pharmacist from Japan on 2011-12-14
Patient: male, weighing 2.7 kg (5.9 pounds)
Reactions: Anaemia Neonatal, Transient Tachypnoea of THE Newborn, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Viracept
Dosage: every day
Lamivudine + Zidovudine
Dosage: every day
Possible Viracept side effects in male
Reported by a pharmacist from Japan on 2011-12-14
Patient: male, weighing 2.8 kg (6.2 pounds)
Reactions: Transient Tachypnoea of THE Newborn, Hypoglycaemia Neonatal, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Lamivudine + Zidovudine
Dosage: unk
Viracept
Dosage: unk
Possible Viracept side effects in male
Reported by a physician from Thailand on 2011-10-13
Patient: male, weighing 2.8 kg (6.2 pounds)
Reactions: Maternal Drugs Affecting Foetus, Sickle Cell Anaemia, Congenital Cytomegalovirus Infection
Drug(s) suspected as cause:
Lamivudine
Dosage: transplacental
Indication: HIV Infection
Start date: 2006-11-19
Zidovudine
Dosage: transplacental
Indication: HIV Infection
Start date: 2006-01-19
Viracept
Dosage: transplacental
Indication: HIV Infection
Start date: 2006-01-19
Possible Viracept side effects in male
Reported by a physician from Thailand on 2011-10-13
Patient: male, weighing 2.8 kg (6.2 pounds)
Reactions: Maternal Drugs Affecting Foetus, Sickle Cell Anaemia, Congenital Cytomegalovirus Infection
Drug(s) suspected as cause:
Zidovudine
Dosage: transplacental
Indication: HIV Infection
Start date: 2006-01-19
Lamivudine
Dosage: transplancental
Indication: HIV Infection
Start date: 2006-11-19
Viracept
Dosage: transplacental
Indication: HIV Infection
Start date: 2006-01-19
Possible Viracept side effects in female
Reported by a health professional (non-physician/pharmacist) on 2011-10-13
Patient: female, weighing 3.1 kg (6.8 pounds)
Reactions: Trisomy 21, Maternal Drugs Affecting Foetus, Premature Baby
Drug(s) suspected as cause:
Zidovudine
Dosage: (600 mg, transplacental
Indication: HIV Infection
Lamivudine
Dosage: (300 mg) , transplacental
Indication: HIV Infection
Viracept
Dosage: (2500 mg), transplacental
Indication: HIV Infection
Possible Viracept side effects in female
Reported by a physician on 2011-10-12
Patient: female
Reactions: Intra-Uterine Death, Maternal Exposure During Pregnancy
Adverse event resulted in: death
Drug(s) suspected as cause:
Zidovudine
Dosage: (600)
Indication: Antiretroviral Therapy
Start date: 2005-12-04
Ritonavir
Dosage: (200)
Indication: Antiretroviral Therapy
Start date: 2007-06-08
Lamivudine
Dosage: (300)
Indication: Antiretroviral Therapy
Start date: 2005-12-04
Viracept
Dosage: (1750)
Indication: Antiretroviral Therapy
Start date: 2005-12-04
End date: 2007-06-08
Lopinavir (Lopinavir)
Dosage: (800)
Indication: Antiretroviral Therapy
Start date: 2007-06-08
Possible Viracept side effects in female
Reported by a physician on 2011-10-12
Patient: female, weighing 3.3 kg (7.3 pounds)
Reactions: Maternal Drugs Affecting Foetus, Congenital Inguinal Hernia
Drug(s) suspected as cause:
Zidovudine
Dosage: transplacental
Indication: HIV Infection
Start date: 2006-06-26
Viracept
Dosage: transplacental
Indication: HIV Infection
Start date: 2006-06-26
Lamivudine
Dosage: transplacental
Indication: HIV Infection
Start date: 2006-06-26
Possible Viracept side effects in male
Reported by a health professional (non-physician/pharmacist) on 2011-10-12
Patient: male, weighing 3.4 kg (7.4 pounds)
Reactions: Gastroschisis, Abdominal Hernia, Maternal Drugs Affecting Foetus, Cardiac Murmur, Cryptorchism, Congenital Anomaly, Abdominal Distension, Exomphalos, Umbilical Hernia
Drug(s) suspected as cause:
Lamivudine
Dosage: 1200 mg (1200 mg, 1 in 1 d), transplacental
Indication: HIV Infection
Start date: 2004-01-30
End date: 2004-06-01
Retrovir
Dosage: 600 mg (600 mg, 1 in 1 d), transplacental
Indication: HIV Infection
Start date: 2004-06-01
End date: 2004-07-20
Truvada
Dosage: 300 mg, transplacental
Indication: HIV Infection
Viracept
Dosage: 2500 mg (2500 mg, 1 in 1 d), transplacental
Indication: HIV Infection
Start date: 2004-01-30
End date: 2004-06-01
Viread
Dosage: 300 mg (300 mg, 1 in 1 d), transplacental
Indication: HIV Infection
Start date: 2004-06-06
End date: 2004-09-10
Zidovudine
Dosage: 600 mg (600 mg, 1 in 1 d), transplacental
Indication: HIV Infection
Start date: 2004-06-01
End date: 2004-07-20
Indinivir Sulfate
Dosage: transplacental
Indication: Product Used FOR Unknown Indication
Start date: 2004-06-01
End date: 2004-07-20
Kaletra
Dosage: 600 mg (600 mg, 1 in 1 d), transplacental
Indication: HIV Infection
Start date: 2001-06-01
Other drugs received by patient: Folic Acid
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