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 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 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 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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