Index of reports
> All Cases (34)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Invirase (Saquinavir) all cases. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 34 Next >>
Possible Invirase side effects in
Reported by a physician from Japan on 2012-08-27
Patient:
Reactions: Hepatic Function Abnormal, Cardiac Failure
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Invirase
Dosage: divided dose requency u
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-26
Isentress
Dosage: divided dose frequency unknown
Administration route: Oral
Indication: HIV Infection
Start date: 2008-07-31
End date: 2011-08-07
Kaletra
Dosage: divided dose frequency unknown
Administration route: Oral
Start date: 2004-08-31
End date: 2006-09-21
Kaletra
Dosage: divided dose frequency unknown
Administration route: Oral
Start date: 2006-10-26
End date: 2011-07-07
Kaletra
Dosage: divided dose frequency unknown
Administration route: Oral
Indication: HIV Infection
Start date: 2002-09-03
End date: 2004-08-04
Other drugs received by patient: Halcion
Possible Invirase side effects in 24 year old male
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 24 year old male
Reactions: Pulmonary Hypertension, Palpitations, Dizziness
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Crixivan
Administration route: Oral
Indication: HIV Infection
Start date: 2000-03-18
End date: 2000-05-24
Efavirenz
Dosage: interrupted from 07/25/00 to 09/25/00 24jul-25jul2000,25sep-02oct2000. film coated tab 200 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2000-07-24
End date: 2000-10-02
Epivir
Dosage: tabs
Administration route: Oral
Indication: HIV Infection
Start date: 2004-05-15
End date: 2008-09-19
Invirase
Dosage: inter:03/18/00-05/24/00,caps 800mg:19jun99-18mar2000.divided dse:24may00-24dec2000,19jun1999-24dc00
Administration route: Oral
Indication: HIV Infection
Start date: 1999-06-19
End date: 2001-03-31
Kaletra
Dosage: 1df,25dec2000-24apr2004:1217 days
Administration route: Oral
Indication: HIV Infection
Start date: 2000-12-25
End date: 2004-04-24
Norvir
Dosage: 31mar2001(interrupted).caps 800mg:19jun99-31oct-99.divided dose:01nov99-24dec2000.25apr2004
Administration route: Oral
Indication: HIV Infection
Start date: 1999-06-19
End date: 2008-09-19
Videx
Dosage: 250,300,400mg12/19/94-3/7/97,3/07/97-7/21/01,7/21/01,125mg,19dc94-7mar97(810d),7mr97-21jl01(1598d)
Administration route: Oral
Indication: HIV Infection
Start date: 1994-12-19
End date: 2001-07-21
Videx EC
Dosage: divided dose
Administration route: Oral
Indication: HIV Infection
Start date: 2001-07-21
End date: 2004-05-14
Zerit
Dosage: 60 mg 8/25/97-27/2/98, 80 mg 2/27-8/3/98, 11/9/98 -6/19/99 and 12/25/00-10/20/01
Administration route: Oral
Indication: HIV Infection
Start date: 1997-08-25
End date: 2001-10-20
Ziagen
Dosage: interrupted from 07/25/00 to 10/20/01 tabs24jul-25jul2000.20oct2001-27oct2001.
Administration route: Oral
Indication: HIV Infection
Start date: 2000-07-24
End date: 2001-10-27
Other drugs received by patient: Cross Eight M
Possible Invirase side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: male
Reactions: Renal Failure, Neoplasm Malignant, Penile Infection, Penis Carcinoma, Escherichia Infection, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invirase
Possible Invirase side effects in 31 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 31 year old female
Reactions: Anaemia
Drug(s) suspected as cause:
Combivir
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2012-03-12
Epzicom
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2012-05-05
Invirase
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2012-03-12
Norvir
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2012-03-12
Possible Invirase side effects in female
Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2012-08-08
Patient: female
Reactions: Anaemia, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
Administration route: Oral
Indication: HIV Infection
Start date: 2012-05-05
Combivir
Dosage: 1u unknown
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-12
Invirase
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-12
Ritonavir
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-12
Possible Invirase side effects in male
Reported by a consumer/non-health professional from France on 2012-07-13
Patient: male
Reactions: Hypospadias, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Abacavir Sulfate and Lamivudine
Indication: Product Used FOR Unknown Indication
Emtricitabine and Tenofovir Disoproxil Fumarate
Indication: Product Used FOR Unknown Indication
Invirase
Indication: Product Used FOR Unknown Indication
Lopinavir and Ritonavir
Indication: Product Used FOR Unknown Indication
Possible Invirase side effects in female
Reported by a consumer/non-health professional from France on 2012-07-10
Patient: female
Reactions: Hypospadias, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Abacavir Sulfate and Lamivudine
Indication: Product Used FOR Unknown Indication
Emtricitabine and Tenofovir Disoproxil Fumarate
Indication: Product Used FOR Unknown Indication
Invirase
Indication: Product Used FOR Unknown Indication
Lopinavir and Ritonavir
Indication: Product Used FOR Unknown Indication
Possible Invirase side effects in male
Reported by a physician from Japan on 2012-07-06
Patient: male
Reactions: Hepatic Function Abnormal, Cardiac Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Didanosine
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-26
Invirase
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-26
Lopinavir and Ritonavir
Administration route: Oral
Indication: HIV Infection
End date: 2006-09-21
Lopinavir and Ritonavir
Administration route: Oral
Start date: 2006-10-26
Raltegravir
Administration route: Oral
Indication: HIV Infection
Other drugs received by patient: Ziagen; Halcion; Viread
Possible Invirase side effects in female
Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2012-07-05
Patient: female
Reactions: Maternal Exposure During Pregnancy, Anaemia
Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
Administration route: Oral
Indication: HIV Infection
Start date: 2012-05-05
Combivir
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-12
Invirase
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-12
Ritonavir
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-12
Possible Invirase side effects in
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-26
Patient:
Reactions: Hepatic Fibrosis
Drug(s) suspected as cause:
Didanosine
Indication: HIV Infection
Invirase
Indication: HIV Infection
Lopinavir
Indication: HIV Infection
Stavudine
Indication: HIV Infection
Zalcitabine
Indication: HIV Infection
Possible Invirase side effects in
Reported by a physician from United States on 2012-06-25
Patient:
Reactions: Fracture
Drug(s) suspected as cause:
Invirase
Possible Invirase side effects in female
Reported by a individual with unspecified qualification from United States on 2012-06-06
Patient: female
Reactions: Neonatal Respiratory Distress Syndrome, Neonatal Tachycardia, Neonatal Tachypnoea, Respiratory Distress, Maternal Exposure Timing Unspecified, Finger Deformity, Trisomy 21, Congenital Eye Disorder, Talipes, Gaze Palsy, Hepatosplenomegaly
Adverse event resulted in: death
Drug(s) suspected as cause:
Invirase
Possible Invirase side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-01
Patient: male
Reactions: Renal Failure, Neoplasm Malignant, Penile Infection, Penis Carcinoma, Escherichia Infection, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invirase
Possible Invirase side effects in female
Reported by a individual with unspecified qualification from United States on 2012-05-30
Patient: female
Reactions: Maternal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Invirase
Other drugs received by patient: Kaletra; Combivir; Isentress
Possible Invirase side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: female
Reactions: Trisomy 21, Congenital Eye Disorder, Talipes, Respiratory Distress, Maternal Exposure Timing Unspecified, Hepatosplenomegaly, Gaze Palsy, Finger Deformity
Adverse event resulted in: death
Drug(s) suspected as cause:
Invirase
Possible Invirase side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-17
Patient: male
Reactions: Neoplasm Malignant, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invirase
Possible Invirase side effects in 48 year old male
Reported by a pharmacist from Germany on 2012-05-15
Patient: 48 year old male
Reactions: Blood Cortisol Decreased, Blood Testosterone Decreased, Blood Oestrogen Decreased, Blood Cholesterol Decreased
Drug(s) suspected as cause:
Invirase
Other drugs received by patient: Kaletra
Possible Invirase side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-30
Patient: female, weighing 71.4 kg (157.2 pounds)
Reactions: Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Blinded Cicletanine
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Invirase
Indication: HIV Infection
Ritonavir
Indication: HIV Infection
Other drugs received by patient: Potassium Chloride; Vitamin C; Ambrisentan; Seroquel
Possible Invirase side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-26
Patient: female, weighing 71.4 kg (157.2 pounds)
Reactions: Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cicletanine Hydrochloride
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2010-05-03
Invirase
Indication: HIV Infection
Start date: 1996-09-01
Norvir
Indication: HIV Infection
Start date: 1996-09-01
Placebo
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Other drugs received by patient: Ascorbic Acid; Seroquel; Multi-Vitamins; Potassium Chloride; Letairis
Possible Invirase side effects in male
Reported by a physician from Japan on 2012-04-18
Patient: male
Reactions: Hepatic Function Abnormal, Cardiac Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invirase
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-26
Lopinavir and Ritonavir
Administration route: Oral
Indication: HIV Infection
Raltegravir
Administration route: Oral
Indication: HIV Infection
Other drugs received by patient: Halcion
Possible Invirase side effects in 46 year old male
Reported by a individual with unspecified qualification from Japan on 2012-04-13
Patient: 46 year old male
Reactions: Blood Alkaline Phosphatase Increased, Hepatic Function Abnormal, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Pericardial Effusion, Gamma-Glutamyltransferase Increased, Cardiac Failure, Aspartate Aminotransferase Increased, Pleural Effusion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invirase
Dosage: 2000 mg/daily/po
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-26
Isentress
Dosage: 800 mg/daily/po
Administration route: Oral
Indication: HIV Infection
Start date: 2008-07-31
Kaletra
Dosage: 4 dose/daily/po
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-26
Kaletra
Dosage: 6 dose/daily/po
Administration route: Oral
Indication: HIV Infection
Start date: 2002-09-03
End date: 2004-08-04
Kaletra
Dosage: 6 dose/daily/po
Administration route: Oral
Indication: HIV Infection
Start date: 2004-08-31
End date: 2006-09-21
Other drugs received by patient: Zerit; Halcion; Videx EC
Possible Invirase side effects in
Reported by a individual with unspecified qualification from Italy on 2012-01-02
Patient:
Reactions: Drug Resistance, Treatment Failure
Drug(s) suspected as cause:
Invirase
Possible Invirase side effects in 53 year old female
Reported by a physician from Portugal on 2011-12-30
Patient: 53 year old female
Reactions: Cardiovascular Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invirase
Indication: HIV Infection
Tenofovir
Administration route: Oral
Indication: HIV Infection
Start date: 2006-12-01
Other drugs received by patient: Zerit; Ritonavir
Possible Invirase side effects in
Reported by a health professional (non-physician/pharmacist) from Netherlands on 2011-12-29
Patient:
Reactions: Hyperbilirubinaemia, Rash
Drug(s) suspected as cause:
Emtricitabine and Tenofovir Disoproxil Fumarate
Indication: HIV Infection
Invirase
Dosage: 2000/100 mg
Indication: HIV Infection
Possible Invirase side effects in 24 year old male
Reported by a consumer/non-health professional from United States on 2011-12-07
Patient: 24 year old male
Reactions: Pulmonary Hypertension, Palpitations, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Dizziness
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Crixivan
Administration route: Oral
Indication: HIV Infection
Start date: 2000-03-18
End date: 2000-05-24
Efavirenz
Dosage: 24-25jul00(2d)-600mg 25sep00-02oct00(8d)
Administration route: Oral
Indication: HIV Infection
Start date: 2000-07-24
End date: 2000-10-02
Epivir
Dosage: tab
Administration route: Oral
Indication: HIV Infection
Start date: 2004-05-15
End date: 2008-09-19
Invirase
Dosage: caps; 19jun99-18mar00(274d) 24may00-24dec00(215d)800mg
Administration route: Oral
Indication: HIV Infection
Start date: 1999-06-19
End date: 2000-12-24
Kaletra
Administration route: Oral
Indication: HIV Infection
Start date: 2000-12-25
End date: 2004-04-24
Norvir
Dosage: 19jun-31oct99;400mg 01nov99-24dec00;420d 100mg/d 24apr05-19sep08;1244d 200mg/d 20sep08-cont
Administration route: Oral
Indication: HIV Infection
Start date: 1999-06-19
Videx
Dosage: 19dec94-7mar97(125mg)810d 8mar97-21jul01(300mg)1597d 22jul-14may04(400mg)1028d
Administration route: Oral
Indication: HIV Infection
Start date: 1994-11-19
End date: 2004-05-14
Zerit
Dosage: 25aug97-27feb98(187d) 27feb-03aug98(158) 3aug-9nov(99) 9nov98-19jn99(223) 25dc00-20oc01(300d)
Administration route: Oral
Indication: HIV Infection
Start date: 1997-08-25
End date: 2001-10-20
Ziagen
Dosage: 24jul-25jul00(2d)600mg 20oct-27oct01(8d)600mg interrupted on 25jul00
Administration route: Oral
Start date: 2000-07-24
End date: 2001-10-27
Other drugs received by patient: Cross Eight M
Possible Invirase side effects in 18 year old
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-06
Patient: 18 year old
Reactions: Hospitalisation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invirase
Possible Invirase side effects in 24 year old male
Reported by a individual with unspecified qualification from Japan on 2011-12-06
Patient: 24 year old male
Reactions: Pulmonary Hypertension, Palpitations, Dizziness, Apparent Life Threatening Event
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Crixivan
Dosage: 800 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2000-03-18
End date: 2000-05-24
Efavirenz
Dosage: 600 mg/daily po ; 600 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2000-09-25
End date: 2000-10-02
Efavirenz
Dosage: 600 mg/daily po ; 600 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2000-07-24
End date: 2000-07-25
Invirase
Dosage: 400 mg/bid po ; 800 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 1999-06-19
End date: 2000-03-18
Invirase
Dosage: 400 mg/bid po ; 800 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2000-05-24
End date: 2000-12-24
Kaletra
Dosage: 6 dose/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2000-12-25
End date: 2004-04-24
Lamivudine
Dosage: 300 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2004-05-15
End date: 2008-09-19
Norvir
Dosage: 400 mg/bid po ; 800 mg/daily po ; 100 mg/daily po ; 200 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 1999-06-19
End date: 1999-10-31
Norvir
Dosage: 400 mg/bid po ; 800 mg/daily po ; 100 mg/daily po ; 200 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2008-09-20
Norvir
Dosage: 400 mg/bid po ; 800 mg/daily po ; 100 mg/daily po ; 200 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2005-04-25
End date: 2008-09-19
Norvir
Dosage: 400 mg/bid po ; 800 mg/daily po ; 100 mg/daily po ; 200 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 1999-11-01
End date: 2000-12-24
Videx
Dosage: 400 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2001-07-21
End date: 2004-05-14
Videx
Dosage: 125 mg/bid po ; 300 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 1994-12-19
End date: 1997-03-07
Videx
Dosage: 125 mg/bid po ; 300 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 1997-03-07
End date: 2001-07-21
Zerit
Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 1998-02-27
End date: 1998-08-03
Zerit
Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 1997-08-25
End date: 1998-02-27
Zerit
Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 1998-08-03
End date: 1998-11-09
Zerit
Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 1998-11-09
End date: 1999-06-19
Zerit
Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2000-12-25
End date: 2001-10-20
Ziagen
Dosage: 600 mg/daily po ; 600 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2000-07-24
End date: 2000-07-25
Ziagen
Dosage: 600 mg/daily po ; 600 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2001-10-20
End date: 2001-10-27
Other drugs received by patient: Antihemophilic Factor (Human)
Possible Invirase side effects in 53 year old female
Reported by a individual with unspecified qualification from Portugal on 2011-12-01
Patient: 53 year old female
Reactions: Cardiovascular Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invirase
Indication: HIV Infection
Tenofovir
Administration route: Oral
Indication: HIV Infection
Start date: 2006-12-01
Other drugs received by patient: Ritonavir; Zerit
Possible Invirase side effects in female
Reported by a consumer/non-health professional from France on 2011-11-21
Patient: female
Reactions: Maternal Exposure Timing Unspecified, Hypospadias
Drug(s) suspected as cause:
Abacavir Sulfate and Lamivudine
Indication: Product Used FOR Unknown Indication
Emtricitabine and Tenofovir Disoproxil Fumarate
Indication: Product Used FOR Unknown Indication
Invirase
Indication: Product Used FOR Unknown Indication
Lopinavir and Ritonavir
Indication: Product Used FOR Unknown Indication
Possible Invirase side effects in male
Reported by a consumer/non-health professional from France on 2011-11-11
Patient: male, weighing 1.6 kg (3.4 pounds)
Reactions: Hypospadias, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Abacavir Sulfate and Lamivudine
Indication: Product Used FOR Unknown Indication
Emtricitabine and Tenofovir Disoproxil Fumarate
Indication: Product Used FOR Unknown Indication
Invirase
Indication: Product Used FOR Unknown Indication
Lopinavir and Ritonavir
Indication: Product Used FOR Unknown Indication
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