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Kaletra (Lopinavir / Ritonavir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Kaletra (Lopinavir / Ritonavir) 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 (929)
Death (178)
Life Threatening Events (67)
Disability (28)

Reports by Reaction Type

Foetal Exposure During Pregnancy (238)Maternal Exposure During Pregnancy (134)Premature Baby (90)Stillbirth (61)Abortion Spontaneous (60)Anaemia (49)Diarrhoea (38)Pyrexia (36)Death (36)Atrial Septal Defect (34)Nausea (31)Foetal Growth Restriction (30)

Below are a few examples of reports where side effects / adverse reactions may be related to Kaletra (Lopinavir / Ritonavir). For a complete list or a specific selection of reports, please use the links above.

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 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 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 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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