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),
Nausea (2),
Angina Pectoris (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 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 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 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 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 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 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
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