DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Viracept (Nelfinavir) - Side Effect Reports to FDA

 
 



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)Sjogren's Syndrome (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 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 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

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 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

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 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 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 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 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



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

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014