DrugLib.com — Drug Information Portal

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

Lexiva (Fosamprenavir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lexiva (Fosamprenavir) 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 (4)
Life Threatening Events (1)

Reports by Reaction Type

Gastrointestinal Haemorrhage (3)Abortion Spontaneous (2)Herpes Zoster (2)Abdominal Discomfort (2)Angina Pectoris (2)Nausea (2)Maternal Exposure During Pregnancy (2)Confusional State (1)Immune Reconstitution Syndrome (1)Foetal Exposure During Pregnancy (1)Somnolence (1)Death (1)

Possible Lexiva side effects in male

Reported by a physician from Japan on 2012-06-12

Patient: male

Reactions: Gastrointestinal Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Epivir
    Dosage: 150 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-09-07
    End date: 2011-12-22

Lexiva
    Dosage: 700 mg, bid
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2011-12-22

Tenofovir Disoproxil Fumarate
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-09-07
    End date: 2011-12-22

Ritonavir
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-01-05
    End date: 2011-12-22

Other drugs received by patient: Kogenate FS



Possible Lexiva side effects in male

Reported by a physician from Japan on 2012-06-11

Patient: male

Reactions: Gastrointestinal Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Lexiva
    Dosage: 1400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-01-05

Viread
    Dosage: 300mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-09-07

Epivir
    Dosage: 300mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-09-07

Other drugs received by patient: Kogenate



Possible Lexiva side effects in male

Reported by a physician from Japan on 2012-06-04

Patient: male

Reactions: Gastrointestinal Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Epivir
    Dosage: 150 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-09-07
    End date: 2011-12-22

Tenofovir Disoproxil Fumarate
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-09-07
    End date: 2011-12-22

Ritonavir
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-01-05
    End date: 2011-12-22

Lexiva
    Dosage: 700 mg, bid
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2011-12-22

Emtricitabine / Tenofovir Disoproxil Fumarate
    Indication: HIV Infection

Other drugs received by patient: Kogenate FS



Possible Lexiva side effects in 37 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-07

Patient: 37 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Truvada
    Administration route: Oral

Lexiva
    Administration route: Oral

Isentress
    Administration route: Oral
    Indication: HIV Infection



Possible Lexiva side effects in 37 year old female

Reported by a physician from United States on 2012-05-07

Patient: 37 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Truvada
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy

Raltegravir
    Dosage: 800mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy

Lexiva
    Dosage: 2800mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy



Possible Lexiva side effects in female

Reported by a physician from Japan on 2012-05-03

Patient: female

Reactions: Angina Pectoris

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Efavirenz
    Dosage: 600mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2001-04-10
    End date: 2008-01-15

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-04-02

Ziagen
    Dosage: 600mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2001-04-10

Reyataz
    Dosage: 400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-01-15
    End date: 2008-04-01

Reyataz
    Dosage: 300mg per day
    Administration route: Oral
    Start date: 2008-04-02
    End date: 2011-10-19

Epivir
    Dosage: 300mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-10-31

Lexiva
    Dosage: 1400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-10-20

Other drugs received by patient: Bufferin; Toledomin; Amlodipine



Possible Lexiva side effects in female

Reported by a physician from Japan on 2012-04-25

Patient: female

Reactions: Angina Pectoris

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ziagen
    Dosage: 600mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2001-04-10

Epivir
    Dosage: 300mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-10-31

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-04-02

Reyataz
    Dosage: 400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-01-15
    End date: 2008-04-01

Reyataz
    Dosage: 300mg per day
    Administration route: Oral
    Start date: 2008-04-02
    End date: 2011-10-19

Lexiva
    Dosage: 1400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-10-20

Other drugs received by patient: Bufferin; Amlodipine



Possible Lexiva side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Lexiva



Possible Lexiva side effects in male

Reported by a physician from Japan on 2012-01-31

Patient: male, weighing 2.7 kg (5.9 pounds)

Reactions: Foetal Exposure During Pregnancy, Anaemia

Drug(s) suspected as cause:
Retrovir
    Dosage: 20.8mg per day
    Administration route: Oral
    Indication: Prophylaxis Against HIV Infection
    Start date: 2011-11-29
    End date: 2012-01-09

Epzicom
    Dosage: 1iuax per day
    Indication: HIV Infection

Norvir
    Dosage: 1iuax per day
    Indication: HIV Infection

Retrovir
    Dosage: 400mg per day
    Start date: 2011-11-29
    End date: 2011-11-29

Lexiva
    Dosage: 2iuax per day
    Indication: HIV Infection



Possible Lexiva side effects in 34 year old male

Reported by a physician from Japan on 2012-01-16

Patient: 34 year old male

Reactions: Nausea, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ritonavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-10-14

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-09-03
    End date: 2010-09-12

Lexiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-09-02

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-10-14

Lexiva
    Administration route: Oral
    Start date: 2010-09-13
    End date: 2010-10-14

Other drugs received by patient: Valtrex; Loperamide HCL; Primperan TAB; Loxonin; Motilium



Possible Lexiva side effects in male

Reported by a physician from Japan on 2011-12-29

Patient: male

Reactions: Muscle Haemorrhage

Drug(s) suspected as cause:
Norvir
    Dosage: 200mg per day
    Administration route: Oral
    Start date: 2008-11-12

Truvada
    Dosage: 1iuax per day
    Administration route: Oral
    Start date: 2008-11-12

Truvada
    Dosage: 1iuax per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-01-04
    End date: 2007-04-27

Lexiva
    Dosage: 1400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-11-12

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-01-04
    End date: 2007-04-27

Other drugs received by patient: Ritonavir; Truvada; Antihemophilic Factor (Human)



Possible Lexiva side effects in 49 year old male

Reported by a consumer/non-health professional from United States on 2011-12-16

Patient: 49 year old male

Reactions: Confusional State, Blood Pressure Increased, Nausea, Hypotension, Headache, Rash, Joint Stiffness, Rash Macular, Myalgia, Abnormal Dreams, Anxiety, Vision Blurred, Dizziness

Drug(s) suspected as cause:
Lexiva
    Dosage: 700mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-02-13

Epzicom
    Dosage: 1tab per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-05
    End date: 2011-05-25

Other drugs received by patient: Losartan Potassium; Claritin; Truvada; Vitamin TAB; Synthroid; Toprol-XL; Xanax; Lexapro; Klonopin



Possible Lexiva side effects in 54 year old male

Reported by a consumer/non-health professional from United States on 2011-12-16

Patient: 54 year old male

Reactions: Diarrhoea, Somnolence

Drug(s) suspected as cause:
Lexiva

Other drugs received by patient: Other Medications



Possible Lexiva side effects in 59 year old male

Reported by a consumer/non-health professional from United States on 2011-12-16

Patient: 59 year old male

Reactions: Diabetic Ketoacidosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lexiva

Other drugs received by patient: Selzentry; Isentress



Possible Lexiva side effects in male

Reported by a physician from Japan on 2011-12-15

Patient: male

Reactions: Abdominal Discomfort

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lexiva
    Dosage: 1400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-09-02

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-10-14

Truvada
    Dosage: 1iuax per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-10-14

Prezista
    Dosage: 800mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-09-03
    End date: 2010-09-12

Lexiva
    Dosage: 1400mg per day
    Administration route: Oral
    Start date: 2010-09-13
    End date: 2010-10-14



Possible Lexiva side effects in 34 year old male

Reported by a physician from Japan on 2011-12-09

Patient: 34 year old male

Reactions: Gastrointestinal Disorder, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lexiva
    Administration route: Oral
    Start date: 2010-09-13
    End date: 2010-10-14

Ritonavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-10-14

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-10-14

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-09-03
    End date: 2010-09-12

Lexiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-09-02

Other drugs received by patient: Primperan TAB; Motilium; Loperamide HCL; Loxonin; Valtrex



Possible Lexiva side effects in male

Reported by a physician from Japan on 2011-12-05

Patient: male

Reactions: Abdominal Discomfort

Drug(s) suspected as cause:
Truvada
    Dosage: 1iuax per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-10-14

Lexiva
    Dosage: 1400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-09-02

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-10-14

Lexiva
    Dosage: 1400mg per day
    Administration route: Oral
    Start date: 2010-09-13
    End date: 2010-10-14

Prezista
    Dosage: 800mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-09-03
    End date: 2010-09-12



Possible Lexiva side effects in male

Reported by a physician from Japan on 2011-11-22

Patient: male

Reactions: Immune Reconstitution Syndrome, Disseminated Tuberculosis, Lung Infection

Drug(s) suspected as cause:
Epzicom
    Dosage: 1iuax per day
    Administration route: Oral
    Indication: Acquired Immunodeficiency Syndrome
    Start date: 2010-10-05

Kaletra
    Dosage: 4iuax per day
    Administration route: Oral
    Indication: Acquired Immunodeficiency Syndrome
    Start date: 2009-07-14
    End date: 2010-10-04

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Acquired Immunodeficiency Syndrome
    Start date: 2011-02-17
    End date: 2011-03-30

Truvada
    Dosage: 1iuax per day
    Administration route: Oral
    Indication: Acquired Immunodeficiency Syndrome
    Start date: 2009-07-14
    End date: 2010-10-04

Prezista
    Dosage: 800mg per day
    Administration route: Oral
    Indication: Acquired Immunodeficiency Syndrome
    Start date: 2011-02-28
    End date: 2011-03-30

Isentress
    Dosage: 800mg per day
    Administration route: Oral
    Indication: Acquired Immunodeficiency Syndrome
    Start date: 2010-10-05
    End date: 2010-10-22

Kaletra
    Dosage: 4iuax per day
    Administration route: Oral
    Start date: 2011-02-17
    End date: 2011-02-27

Isentress
    Dosage: 800mg per day
    Administration route: Oral
    Start date: 2011-03-31

Lexiva
    Dosage: 2800mg per day
    Administration route: Oral
    Indication: Acquired Immunodeficiency Syndrome
    Start date: 2010-10-23
    End date: 2011-02-16

Other drugs received by patient: Sulfamethoxazole and Trimethoprim



Possible Lexiva side effects in 30 year old male

Reported by a pharmacist from Japan on 2011-11-07

Patient: 30 year old male

Reactions: Hepatic Function Abnormal

Drug(s) suspected as cause:
Lexiva
    Dosage: 4iuax per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-07-01
    End date: 2011-10-26

Truvada
    Dosage: 500mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-07-01
    End date: 2011-10-26



Possible Lexiva side effects in male

Reported by a physician from Japan on 2011-11-04

Patient: male

Reactions: Anal Fistula, Calculus Urinary, Renal Failure Acute

Drug(s) suspected as cause:
Epivir
    Dosage: 300mg per day
    Administration route: Oral
    Start date: 2004-04-20
    End date: 2008-06-04

Epivir
    Dosage: 300mg per day
    Administration route: Oral
    Start date: 2008-06-13

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Start date: 2004-06-15
    End date: 2008-06-04

Ziagen
    Dosage: 600mg per day
    Administration route: Oral
    Start date: 2008-06-13

Reyataz
    Dosage: 400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-04-20
    End date: 2004-06-14

Reyataz
    Dosage: 300mg per day
    Administration route: Oral
    Start date: 2004-06-15
    End date: 2008-06-04

Epivir
    Dosage: 300mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1997-04-17
    End date: 1997-05-14

Epivir
    Dosage: 300mg per day
    Administration route: Oral
    Start date: 1997-10-02
    End date: 1999-10-31

Norvir
    Dosage: 400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-11-20
    End date: 2003-12-02

Lexiva
    Dosage: 1400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-06-13

Epivir
    Dosage: 300mg per day
    Administration route: Oral
    Start date: 2003-04-01
    End date: 2003-12-03

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Start date: 2008-06-13

Epivir
    Dosage: 300mg per day
    Administration route: Oral
    Start date: 1999-11-01
    End date: 2003-03-31

Ziagen
    Dosage: 600mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-04-20
    End date: 2008-06-04

Other drugs received by patient: Magnesium Sulfate; Risperdal; Loxoprofen

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

All Rights reserved - Copyright DrugLib.com, 2006-2012