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Kaletra (Lopinavir / Ritonavir) - Serious Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Serious Events (905)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Kaletra (Lopinavir / Ritonavir) serious events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 905   Next >>

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

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 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 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 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 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 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 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 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



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



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