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Index of reports
> All Cases (929)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Kaletra (Lopinavir / Ritonavir) all cases. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 929 Next >>
Possible Kaletra 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:
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
Invirase
Dosage: divided dose requency u
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-26
Kaletra
Dosage: divided dose frequency unknown
Administration route: Oral
Indication: HIV Infection
Start date: 2002-09-03
End date: 2004-08-04
Isentress
Dosage: divided dose frequency unknown
Administration route: Oral
Indication: HIV Infection
Start date: 2008-07-31
End date: 2011-08-07
Other drugs received by patient: Halcion
Possible Kaletra side effects in male
Reported by a physician from France on 2012-08-27
Patient: male
Reactions: Myalgia, Burning Sensation, Amyotrophy, Decreased Appetite
Drug(s) suspected as cause:
Combivir
Dosage: 1unit twice per day
Administration route: Oral
Indication: HIV Infection
Start date: 2002-10-17
End date: 2012-06-03
Kaletra
Dosage: 2tab twice per day
Administration route: Oral
Indication: HIV Infection
Start date: 2002-10-17
End date: 2012-06-15
Possible Kaletra side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient:
Reactions: Ultrasound Scan Abnormal, Foetal Exposure During Pregnancy, Abortion Induced, Talipes, Meningomyelocele
Adverse event resulted in: death
Drug(s) suspected as cause:
Combivir
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
Possible Kaletra side effects in female
Reported by a physician from France on 2012-08-24
Patient: female
Reactions: Cholestasis of Pregnancy, Maternal Exposure During Pregnancy, Adverse Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kaletra
Dosage: 2tab twice per day
Administration route: Oral
Indication: Antiviral Prophylaxis
Start date: 2012-03-19
End date: 2012-05-24
Abacavir Sulfate / Lamivudine
Dosage: 1tab per day
Administration route: Oral
Indication: Antiviral Prophylaxis
Start date: 2012-03-05
End date: 2012-03-19
Combivir
Dosage: 1tab twice per day
Administration route: Oral
Indication: Antiviral Prophylaxis
Start date: 2012-03-19
End date: 2012-05-24
Possible Kaletra side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-24
Patient: male
Reactions: Renal Failure, Coma, Convulsion
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Rifabutin
Administration route: Oral
Indication: Atypical Mycobacterium Pericarditis
Start date: 2012-07-11
Prazepam
Dosage: 1 unit
Administration route: Oral
Start date: 2012-07-10
Olanzapine
Dosage: 1 unit
Administration route: Oral
Start date: 2012-01-01
Truvada
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-01
Leucovorin Calcium
Administration route: Oral
Start date: 2012-07-10
Acetaminophen
Indication: Pain
Start date: 2012-07-11
Kaletra
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-01
Acupan
Indication: Pain
Start date: 2012-07-16
End date: 2012-07-27
Potassium Chloride
Administration route: Oral
Start date: 2012-07-10
Clarithromycin
Administration route: Oral
Indication: Atypical Mycobacterium Pericarditis
Start date: 2012-07-11
Amikacin
Indication: Atypical Mycobacterium Pericarditis
Start date: 2012-07-11
Cernevit-12
Indication: Vitamin Supplementation
Start date: 2012-07-10
End date: 2012-08-02
Perikabiven
Indication: Parenteral Nutrition
Start date: 2012-07-10
Isentress
Administration route: Oral
Indication: HIV Infection
Start date: 2012-05-01
Bactrim
Administration route: Oral
Indication: Atypical Mycobacterium Pericarditis
Start date: 2012-07-13
Myambutol
Dosage: 2 units
Administration route: Oral
Start date: 2012-07-11
Possible Kaletra side effects in male
Reported by a physician from Japan on 2012-08-24
Patient: male, weighing 59.5 kg (130.9 pounds)
Reactions: Pulmonary Hypertension, Hepatic Function Abnormal, Fibrin Degradation Products Increased, Nausea, Tremor, Palpitations, Visual Impairment, Dizziness, Nervous System Disorder, Influenza Like Illness
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Norvir
Administration route: Oral
Start date: 2008-09-20
Abacavir Sulfate
Administration route: Oral
Indication: HIV Infection
Start date: 2000-07-24
End date: 2000-07-25
Stavudine
Dosage: daily
Administration route: Oral
Indication: HIV Infection
Start date: 1997-08-25
End date: 2001-10-20
Didanosine
Administration route: Oral
Start date: 2001-07-21
End date: 2004-05-14
Saquinavir
Administration route: Oral
Indication: HIV Infection
Start date: 1999-06-19
End date: 2000-03-18
Norvir
Administration route: Oral
Start date: 2004-04-25
End date: 2008-09-19
Efavirenz
Administration route: Oral
Start date: 2000-09-25
End date: 2000-10-02
Didanosine
Administration route: Oral
Indication: HIV Infection
Start date: 1994-11-19
End date: 2001-07-21
Norvir
Administration route: Oral
Indication: HIV Infection
Start date: 1999-06-19
End date: 2000-12-24
Abacavir Sulfate
Administration route: Oral
Start date: 2001-10-20
End date: 2001-10-27
Efavirenz
Administration route: Oral
Indication: HIV Infection
Start date: 2000-07-24
End date: 2000-07-25
Lamivudine
Administration route: Oral
Indication: HIV Infection
Start date: 2004-05-15
End date: 2008-09-19
Saquinavir
End date: 2001-03-31
Saquinavir
Administration route: Oral
Start date: 2000-05-24
End date: 2000-12-24
Kaletra
Administration route: Oral
Indication: HIV Infection
End date: 2004-04-24
Indinavir
Administration route: Oral
Indication: HIV Infection
Start date: 2000-03-08
End date: 2000-05-24
Peginterferon Alfa-2B
Indication: Hepatitis C
Start date: 2002-08-17
End date: 2003-07-12
Other drugs received by patient: Truvada; Amlodipine Besylate; Lexiva; Coagulation Factor Viii; Olmesartan Medoxomil; Tenofovir Disoproxil Fumarate; Isentress; Cross Eight M; Ribavirin; Coagulation Factor Viii; Ribavirin; Atazanavir
Possible Kaletra side effects in male
Reported by a physician from Chile on 2012-08-24
Patient: male, weighing 87.0 kg (191.4 pounds)
Reactions: Asthmatic Crisis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Kaletra
Other drugs received by patient: Lamivudine (Epivir Hbv); Escitalopram; Valproic Acid; Flemar; Clotiazepam; Acyclovir
Possible Kaletra side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: male
Reactions: Cleft LIP and Palate, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Possible Kaletra side effects in female
Reported by a physician from United States on 2012-08-24
Patient: female, weighing 2.9 kg (6.3 pounds)
Reactions: Mass, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Kaletra
Other drugs received by patient: Multi-Vitamins; Combivir; Metronidazole
Possible Kaletra side effects in 5 month old
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23
Patient: 5 month old
Reactions: Immune Reconstitution Syndrome, Nephrotic Syndrome
Drug(s) suspected as cause:
Kaletra
Indication: HIV Infection
Nevirapine
Indication: HIV Infection
Lamivudine
Indication: HIV Infection
Zidovudine
Indication: HIV Infection
Possible Kaletra side effects in 27 year old female
Reported by a physician from United States on 2012-08-23
Patient: 27 year old female
Reactions: Stillbirth
Drug(s) suspected as cause:
Kaletra
Administration route: Oral
Indication: HIV Infection
Start date: 2008-12-18
End date: 2009-02-17
Kaletra
Administration route: Oral
Start date: 2009-02-17
Other drugs received by patient: Combivir
Possible Kaletra side effects in female
Reported by a physician from Israel on 2012-08-23
Patient: female
Reactions: Caesarean Section
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kaletra
Other drugs received by patient: Combivir
Possible Kaletra side effects in 5 month old
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23
Patient: 5 month old
Reactions: Immune Reconstitution Syndrome, Nephrotic Syndrome
Drug(s) suspected as cause:
Nevirapine
Indication: HIV Infection
Kaletra
Indication: HIV Infection
Lamivudine
Indication: HIV Infection
Zidovudine
Indication: HIV Infection
Possible Kaletra side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: female
Reactions: Foetal Growth Restriction
Adverse event resulted in: death
Drug(s) suspected as cause:
Kaletra
Other drugs received by patient: Combivir
Possible Kaletra side effects in 5 month old
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23
Patient: 5 month old
Reactions: Immune Reconstitution Syndrome, Nephrotic Syndrome
Drug(s) suspected as cause:
Nevirapine
Indication: HIV Infection
Kaletra
Indication: HIV Infection
Lamivudine
Indication: HIV Infection
Zidovudine
Indication: HIV Infection
Possible Kaletra side effects in male
Reported by a physician from United States on 2012-08-23
Patient: male, weighing 2.7 kg (5.9 pounds)
Reactions: Foetal Exposure During Pregnancy, Ventricular Septal Defect
Drug(s) suspected as cause:
Kaletra
Other drugs received by patient: Combivir; Retrovir
Possible Kaletra side effects in 30 year old female
Reported by a physician from United States on 2012-08-23
Patient: 30 year old female
Reactions: Stillbirth
Drug(s) suspected as cause:
Kaletra
Other drugs received by patient: Combivir
Possible Kaletra side effects in 5 month old
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23
Patient: 5 month old
Reactions: Immune Reconstitution Syndrome, Nephrotic Syndrome
Drug(s) suspected as cause:
Zidovudine
Indication: HIV Infection
Lamivudine
Indication: HIV Infection
Kaletra
Indication: HIV Infection
Nevirapine
Indication: HIV Infection
Possible Kaletra side effects in male
Reported by a physician from United States on 2012-08-23
Patient: male, weighing 2.6 kg (5.7 pounds)
Reactions: Foetal Growth Restriction, Premature Baby, Foetal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Norvir
Indication: Maternal Exposure Timing Unspecified
Other drugs received by patient: Combivir; Zidovudine; Darunavir Ethanolate
Possible Kaletra side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: male
Reactions: Foetal Exposure During Pregnancy, Congenital Anomaly
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Combivir
Indication: Maternal Exposure Timing Unspecified
Possible Kaletra side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female
Reactions: Maternal Exposure During Pregnancy, Pregnancy, Congenital Anomaly in Offspring
Drug(s) suspected as cause:
Lamivudine
Dosage: unk
Administration route: Oral
Indication: Antiretroviral Therapy
End date: 2010-06-10
Zidovudine
Dosage: unk
Administration route: Oral
Indication: Antiretroviral Therapy
End date: 2010-06-10
Nevirapine
Dosage: unk
Administration route: Oral
Indication: Antiretroviral Therapy
End date: 2010-06-10
Kaletra
Dosage: unk
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2010-06-10
Tenofovir Disoproxil Fumarate
Dosage: unk
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2010-06-10
Isentress
Dosage: 800 mg/day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2010-06-10
Possible Kaletra side effects in
Reported by a physician from Japan on 2012-08-22
Patient:
Reactions: Diabetes Mellitus, Hypertriglyceridaemia
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Epivir
Dosage: 150 mg, bid
Administration route: Oral
Indication: HIV Infection
Start date: 2003-09-16
End date: 2006-02-28
Isentress
Dosage: 800 mg divided dose frequency u
Administration route: Oral
Start date: 2008-08-05
Epivir
Dosage: 150 mg, bid
Administration route: Oral
Start date: 2008-12-16
Intelence
Dosage: 200 mg, bid
Administration route: Oral
Indication: HIV Infection
Start date: 2009-02-11
Kaletra
Dosage: 4 df
Administration route: Oral
Indication: HIV Infection
Start date: 2007-07-04
End date: 2008-01-08
Zerit
Dosage: 60 mg divided dose frequency u
Administration route: Oral
Start date: 2008-12-16
End date: 2009-02-10
Truvada
Dosage: 1 df, unk
Administration route: Oral
Start date: 2008-08-05
End date: 2008-12-15
Zerit
Dosage: 80 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2003-09-16
End date: 2006-02-28
Prezista
Dosage: 1200 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2008-01-09
End date: 2008-05-01
Truvada
Dosage: 1df
Administration route: Oral
Indication: HIV Infection
Start date: 2007-07-04
End date: 2008-05-01
Other drugs received by patient: Rhythmy
Possible Kaletra side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: male
Reactions: Volvulus, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Zidovudine
Dosage: unk
Indication: Maternal Exposure During Pregnancy
End date: 2010-06-10
Tenofovir Disoproxil Fumarate
Dosage: unk
Indication: Maternal Exposure During Pregnancy
Start date: 2010-06-10
Isentress
Dosage: 800 mg/day
Indication: Maternal Exposure During Pregnancy
Start date: 2010-06-10
Nevirapine
Dosage: unk
Indication: Maternal Exposure During Pregnancy
End date: 2010-06-10
Kaletra
Dosage: unk
Indication: Maternal Exposure During Pregnancy
Start date: 2010-06-10
Lamivudine
Dosage: unk
Indication: Maternal Exposure During Pregnancy
End date: 2010-06-10
Possible Kaletra side effects in male
Reported by a physician from France on 2012-08-22
Patient: male
Reactions: Myalgia, Burning Sensation, Amyotrophy, Decreased Appetite
Drug(s) suspected as cause:
Combivir
Dosage: dosage form: 150/300 mg, 2 in 1 day
Administration route: Oral
Indication: HIV Infection
Start date: 2002-10-17
End date: 2012-06-03
Kaletra
Administration route: Oral
Indication: HIV Infection
Start date: 2002-10-17
End date: 2012-06-15
Possible Kaletra side effects in male
Reported by a physician from Japan on 2012-08-22
Patient: male
Reactions: Hypophosphataemia, Diarrhoea, Cardiac Failure, Lactic Acidosis, Liver Disorder
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Kaletra
Administration route: Oral
Indication: HIV Infection
Start date: 2002-09-03
End date: 2004-08-04
Kaletra
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-26
End date: 2011-08-07
Abacavir
Administration route: Oral
Indication: HIV Infection
Start date: 2004-08-31
End date: 2006-09-21
Kaletra
Administration route: Oral
Start date: 2004-08-31
End date: 2006-09-21
Didanosine
Administration route: Oral
Indication: HIV Infection
Start date: 2002-09-03
End date: 2004-08-04
Didanosine
Administration route: Oral
Start date: 2004-08-31
End date: 2006-09-21
Didanosine
Administration route: Oral
Start date: 2006-10-26
Tenofovir Disoproxil Fumarate
Administration route: Oral
Indication: HIV Infection
Start date: 2004-08-31
End date: 2006-09-21
Isentress
Dosage: 800mg daily
Administration route: Oral
Indication: HIV Infection
Start date: 2011-08-07
Stavudine
Administration route: Oral
Indication: HIV Infection
Start date: 2002-04-01
End date: 2004-08-04
Other drugs received by patient: Glycyron; Saquinavir; Allopurinol; Bifidobacterium; Loperamide HCL; Allopurinol
Possible Kaletra side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient:
Reactions: Atrial Septal Defect, Jaundice, Cardiac Murmur, Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Anaemia, Ascites, Hydrops Foetalis, Talipes
Drug(s) suspected as cause:
Combivir
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
Possible Kaletra side effects in 44 year old female
Reported by a physician from United States on 2012-08-21
Patient: 44 year old female
Reactions: Drug Intolerance
Drug(s) suspected as cause:
Norvir
Administration route: Oral
Indication: HIV Infection
Start date: 2011-08-09
Kaletra
Administration route: Oral
Indication: HIV Infection
Start date: 2011-05-17
End date: 2011-08-09
Other drugs received by patient: Combivir; Reyataz
Possible Kaletra side effects in male
Reported by a health professional (non-physician/pharmacist) from Argentina on 2012-08-21
Patient: male
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Ventricular Septal Defect
Drug(s) suspected as cause:
Nevirapine
Indication: Maternal Exposure Timing Unspecified
Tenofovir Disoproxil Fumarate
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
Lamivudine / Zidovudine
Indication: Maternal Exposure Timing Unspecified
Possible Kaletra 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:
Videx EC
Dosage: divided dose
Administration route: Oral
Indication: HIV Infection
Start date: 2001-07-21
End date: 2004-05-14
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
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
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
Crixivan
Administration route: Oral
Indication: HIV Infection
Start date: 2000-03-18
End date: 2000-05-24
Kaletra
Dosage: 1df,25dec2000-24apr2004:1217 days
Administration route: Oral
Indication: HIV Infection
Start date: 2000-12-25
End date: 2004-04-24
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
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
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
Other drugs received by patient: Cross Eight M
Possible Kaletra side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: female
Reactions: Atrial Septal Defect, Cardiac Murmur, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Pyelocaliectasis
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
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