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

 
 



Index of reports > Life Threatening Events (67)

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

 Reports 1 - 30 of 67   Next >>

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:
Abacavir Sulfate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2000-07-25

Abacavir Sulfate
    Administration route: Oral
    Start date: 2001-10-20
    End date: 2001-10-27

Didanosine
    Administration route: Oral
    Start date: 2001-07-21
    End date: 2004-05-14

Didanosine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1994-11-19
    End date: 2001-07-21

Efavirenz
    Administration route: Oral
    Start date: 2000-09-25
    End date: 2000-10-02

Efavirenz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2000-07-25

Indinavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-03-08
    End date: 2000-05-24

Kaletra
    Administration route: Oral
    Indication: HIV Infection
    End date: 2004-04-24

Lamivudine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-05-15
    End date: 2008-09-19

Norvir
    Administration route: Oral
    Start date: 2008-09-20

Norvir
    Administration route: Oral
    Start date: 2004-04-25
    End date: 2008-09-19

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 2000-12-24

Peginterferon Alfa-2B
    Indication: Hepatitis C
    Start date: 2002-08-17
    End date: 2003-07-12

Saquinavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 2000-03-18

Saquinavir
    End date: 2001-03-31

Saquinavir
    Administration route: Oral
    Start date: 2000-05-24
    End date: 2000-12-24

Stavudine
    Dosage: daily
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1997-08-25
    End date: 2001-10-20

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 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:
Acetaminophen
    Indication: Pain
    Start date: 2012-07-11

Acupan
    Indication: Pain
    Start date: 2012-07-16
    End date: 2012-07-27

Amikacin
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-11

Bactrim
    Administration route: Oral
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-13

Cernevit-12
    Indication: Vitamin Supplementation
    Start date: 2012-07-10
    End date: 2012-08-02

Clarithromycin
    Administration route: Oral
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-11

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-01

Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01

Leucovorin Calcium
    Administration route: Oral
    Start date: 2012-07-10

Myambutol
    Dosage: 2 units
    Administration route: Oral
    Start date: 2012-07-11

Olanzapine
    Dosage: 1 unit
    Administration route: Oral
    Start date: 2012-01-01

Perikabiven
    Indication: Parenteral Nutrition
    Start date: 2012-07-10

Potassium Chloride
    Administration route: Oral
    Start date: 2012-07-10

Prazepam
    Dosage: 1 unit
    Administration route: Oral
    Start date: 2012-07-10

Rifabutin
    Administration route: Oral
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-11

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01



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 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:
Abacavir
    Administration route: Oral
    Indication: HIV Infection
    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

Isentress
    Dosage: 800mg daily
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-08-07

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

Kaletra
    Administration route: Oral
    Start date: 2004-08-31
    End date: 2006-09-21

Stavudine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-04-01
    End date: 2004-08-04

Tenofovir Disoproxil Fumarate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-08-31
    End date: 2006-09-21

Other drugs received by patient: Glycyron; Saquinavir; Allopurinol; Bifidobacterium; Loperamide HCL; Allopurinol



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:
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 Kaletra side effects in male

Reported by a physician from France on 2012-08-16

Patient: male

Reactions: Agitation, Urinary Incontinence, Coma, Coma Scale Abnormal, Pyrexia, Hepatotoxicity, Eye Movement Disorder, Hepatosplenomegaly, Anaemia, Malnutrition, General Physical Health Deterioration, Encephalopathy, Faecal Incontinence, Convulsion, Respiratory Tract Congestion, Apathy, Depressed Level of Consciousness, Nervous System Disorder, Confusional State, Immune Reconstitution Syndrome, Snoring, Hepatitis Cholestatic, Intracranial Pressure Increased, Hepatic Ischaemia, Thrombocytopenia, Oxygen Saturation Decreased, Refusal of Treatment by Patient, Necrotising Granulomatous Lymphadenitis, Hepatic Fibrosis, Mycobacterial Infection, Hyponatraemia, Cerebral Atrophy, White Blood Cell Disorder, Renal Failure, Hypoproteinaemia, Diarrhoea, Brain Abscess, Heart Rate Increased, Encephalitic Infection, Heart Sounds Abnormal

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Dosage: df 10mg/ml
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Amikacin
    Dosage: 900 mg daily
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Bactrim
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Cernevit-12
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Clarithromycin
    Dosage: df 50mg/ml
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Folic Acid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-01

Kaletra
    Dosage: df 80/20 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01

Myambutol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Nefopam
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Olanzapine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Perikabiven (Parenteral Nutrition)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Potassium Chloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Prazepam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Rifabutin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01

Viramune
    Indication: HIV Infection
    Start date: 2012-03-01
    End date: 2012-05-01

Other drugs received by patient: Propofol; Adavat



Possible Kaletra side effects in male

Reported by a physician from France on 2012-08-15

Patient: male

Reactions: Agitation, Urinary Incontinence, Coma, Pyrexia, Coma Scale Abnormal, Hepatotoxicity, Eye Movement Disorder, Hepatosplenomegaly, Anaemia, Malnutrition, Encephalopathy, Faecal Incontinence, General Physical Health Deterioration, Convulsion, Apathy, Respiratory Tract Congestion, Depressed Level of Consciousness, Nervous System Disorder, Confusional State, Immune Reconstitution Syndrome, Snoring, Hepatitis Cholestatic, Intracranial Pressure Increased, Hepatic Ischaemia, Thrombocytopenia, Oxygen Saturation Decreased, Refusal of Treatment by Patient, Necrotising Granulomatous Lymphadenitis, Hepatic Fibrosis, Mycobacterial Infection, Cerebral Atrophy, Hyponatraemia, Renal Failure, White Blood Cell Disorder, Diarrhoea, Hypoproteinaemia, Heart Rate Increased, Brain Abscess, Encephalitic Infection, Heart Sounds Abnormal

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Dosage: df 10mg/ml
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Amikacin
    Dosage: 900 mg daily
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Bactrim
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Cernevit-12
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Clarithromycin
    Dosage: df 50mg/ml
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Folic Acid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-01

Kaletra
    Dosage: df 80/20 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01

Myambutol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Nefopam
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Olanzapine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Perikabiven (Parenteral Nutrition)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Potassium Chloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Prazepam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Rifabutin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01

Viramune
    Indication: HIV Infection
    Start date: 2012-03-01
    End date: 2012-05-01

Other drugs received by patient: Adavat; Propofol



Possible Kaletra side effects in male

Reported by a physician from France on 2012-08-15

Patient: male

Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Fungal Infection, Dysphonia, Oral Candidiasis, Foetal Heart Rate Disorder, Oesophageal Atresia, Venous Thrombosis Limb, Cough, Oxygen Saturation Decreased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Epzicom
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in

Reported by a physician from Russian Federation on 2012-08-14

Patient:

Reactions: Atelectasis Neonatal, Neonatal Respiratory Distress Syndrome, Premature Baby, Respiratory Failure, Congenital Hydrocephalus, Foetal Exposure During Pregnancy, Cerebral Atrophy, Cerebellar Hypoplasia

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Kaletra



Possible Kaletra side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient:

Reactions: Coma, Convulsion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 500 mg, qd
    Start date: 2012-07-11

Acupan
    Dosage: 120 mg, qd
    Start date: 2012-07-16
    End date: 2012-07-27

Amikacin
    Dosage: 900 mg, qd
    Start date: 2012-07-11

Bactrim
    Dosage: 800 mg, qd
    Start date: 2012-07-13

Cernevit-12
    Dosage: unk
    Start date: 2012-07-10
    End date: 2012-08-02

Clarithromycin
    Dosage: 500 mg, qd
    Administration route: Oral
    Start date: 2012-07-11

Isentress
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-01

Kaletra
    Dosage: unk
    Indication: HIV Infection
    Start date: 2012-03-01

Leucovorin Calcium
    Dosage: unk
    Administration route: Oral
    Start date: 2012-07-10

Myambutol
    Dosage: 1 df, bid
    Start date: 2012-07-11

Olanzapine
    Dosage: 5 mg, unk
    Administration route: Oral
    Start date: 2012-01-01

Perikabiven
    Dosage: unk
    Start date: 2012-07-10

Potassium Chloride
    Dosage: unk
    Administration route: Oral
    Start date: 2012-07-10

Prazepam
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2012-07-10

Rifabutin
    Dosage: unk
    Start date: 2012-07-11

Truvada
    Dosage: unk
    Indication: HIV Infection
    Start date: 2012-03-01



Possible Kaletra side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13

Patient: male

Reactions: Confusional State, Agitation, Refusal of Treatment by Patient, Malnutrition, Anaemia, Coma, General Physical Health Deterioration, Pyrexia, Convulsion, Apathy, Hepatotoxicity, Diarrhoea, Thrombocytopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Acupan
    Dosage: 120 mg, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-16
    End date: 2012-07-27

Amikacin
    Dosage: 900 mg, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Bactrim
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-13

Cernevit / 01027001 /
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-08-02

Clarithromycin
    Dosage: 500 mg, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Isentress
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-01

Kaletra
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01

Leucovorin Calcium
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Myambutol
    Dosage: 2 df, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Olanzapine
    Dosage: 1 df, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Perikabiven
    Dosage: unk
    Indication: Parenteral Nutrition
    Start date: 2012-07-10

Potassium Chloride
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Prazepam
    Dosage: 1 df, qd
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Rifabutin
    Dosage: 150 mg, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Truvada
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01



Possible Kaletra side effects in 41 year old female

Reported by a physician from Thailand on 2012-08-13

Patient: 41 year old female

Reactions: Anaemia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Kaletra

Other drugs received by patient: Lamivudine; Zidovudine



Possible Kaletra side effects in male

Reported by a physician from France on 2012-08-02

Patient: male, weighing 4.7 kg (10.3 pounds)

Reactions: Hypothermia, Foetal Exposure During Pregnancy, Anaemia, Tachycardia, Lactic Acidosis, Foetal Distress Syndrome, Apparent Death, Electroencephalogram Abnormal, Renal Failure, Rash Erythematous, Thrombocytopenia, Leukopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Indication: Prophylaxis
    Start date: 2011-01-01
    End date: 2012-06-26

Kaletra
    Indication: Prophylaxis
    Start date: 2011-01-01
    End date: 2012-06-26

Retrovir
    Start date: 2012-06-26
    End date: 2012-06-29

Retrovir
    Indication: Prophylaxis
    Start date: 2012-06-26
    End date: 2012-06-26



Possible Kaletra side effects in male

Reported by a physician from Chile on 2012-07-31

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)



Possible Kaletra side effects in male

Reported by a physician from France on 2012-07-27

Patient: male

Reactions: Foetal Exposure During Pregnancy, Anaemia, Lactic Acidosis, Ill-Defined Disorder, Hepatic Enzyme Increased, Apparent Death, Foetal Distress Syndrome, Renal Failure, C-Reactive Protein Increased, Thrombocytopenia, Leukopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Prophylaxis Against HIV Infection
    Start date: 2012-06-26
    End date: 2012-06-26

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in male

Reported by a physician from Germany on 2012-07-26

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Leishmaniasis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Kaletra

Other drugs received by patient: Truvada



Possible Kaletra side effects in male

Reported by a physician from France on 2012-07-20

Patient: male

Reactions: Foetal Exposure During Pregnancy, Anaemia, Lactic Acidosis, Ill-Defined Disorder, Hepatic Enzyme Increased, Apparent Death, Foetal Distress Syndrome, Renal Failure, C-Reactive Protein Increased, Thrombocytopenia, Leukopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Prophylaxis Against HIV Infection
    Start date: 2012-06-26
    End date: 2012-06-26

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in male

Reported by a physician from France on 2012-07-17

Patient: male, weighing 4.7 kg (10.3 pounds)

Reactions: Hypothermia, Tachycardia, Foetal Exposure During Pregnancy, Anaemia, Lactic Acidosis, Electroencephalogram Abnormal, Foetal Distress Syndrome, Apparent Death, Renal Failure, Rash Erythematous, Thrombocytopenia, Leukopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Indication: Prophylaxis
    Start date: 2011-01-01
    End date: 2012-06-26

Kaletra
    Indication: Prophylaxis
    Start date: 2011-01-01
    End date: 2012-06-26

Retrovir
    Start date: 2012-06-26
    End date: 2012-06-29

Retrovir
    Indication: Prophylaxis
    Start date: 2012-06-26
    End date: 2012-06-26



Possible Kaletra side effects in male

Reported by a physician from France on 2012-07-16

Patient: male

Reactions: Anaemia, Foetal Exposure During Pregnancy, Lactic Acidosis, Ill-Defined Disorder, Hepatic Enzyme Increased, Foetal Distress Syndrome, Apparent Death, Renal Failure, C-Reactive Protein Increased, Thrombocytopenia, Leukopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Prophylaxis Against HIV Infection
    Start date: 2012-06-26
    End date: 2012-06-26



Possible Kaletra side effects in male

Reported by a physician from Russian Federation on 2012-07-03

Patient: male

Reactions: Blood Cholesterol Increased, Myocardial Infarction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Dosage: 1tab per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-20

Combivir
    Indication: HIV Infection
    Start date: 2007-01-01

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-20

Kaletra
    Indication: HIV Infection
    Start date: 2007-01-01



Possible Kaletra side effects in

Reported by a physician from Russian Federation on 2012-06-27

Patient:

Reactions: Foetal Exposure During Pregnancy, Cerebral Atrophy, Hydrocephalus

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Kaletra



Possible Kaletra side effects in female

Reported by a pharmacist from United States on 2012-06-25

Patient: female, weighing 1.0 kg (2.2 pounds)

Reactions: Premature Baby, Atrioventricular Block Complete, Maternal Exposure During Pregnancy, Toxicity To Various Agents, Cardiomyopathy

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Kaletra
    Dosage: 460/115 mg/m**2 per day
    Indication: Prophylaxis Against HIV Infection
    Start date: 2006-12-10

Lamivudine
    Indication: Prophylaxis Against HIV Infection
    Start date: 2006-12-10

Lamivudine
    Indication: Maternal Exposure Timing Unspecified

Lopinavir and Ritonavir
    Indication: Maternal Exposure Timing Unspecified

Tenofovir Disoproxil Fumarate
    Indication: Maternal Exposure Timing Unspecified

Tenofovir Disoproxil Fumarate
    Start date: 2006-12-10

Zidovudine
    Indication: Prophylaxis Against HIV Infection
    Start date: 2006-12-10



Possible Kaletra side effects in male

Reported by a pharmacist from United States on 2012-06-25

Patient: male, weighing 1.1 kg (2.4 pounds)

Reactions: Premature Baby, Maternal Exposure During Pregnancy, Atrioventricular Block Complete, Toxicity To Various Agents, Cardiomyopathy

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Kaletra
    Dosage: 460/115 mg/m**2 per day
    Indication: Prophylaxis Against HIV Infection
    Start date: 2006-12-10

Lamivudine
    Indication: Maternal Exposure Timing Unspecified

Lamivudine
    Indication: Prophylaxis Against HIV Infection
    Start date: 2006-12-10

Lopinavir and Ritonavir
    Indication: Maternal Exposure Timing Unspecified

Tenofovir Disoproxil Fumarate
    Indication: Maternal Exposure Timing Unspecified

Zidovudine
    Indication: Prophylaxis Against HIV Infection
    Start date: 2006-12-10



Possible Kaletra side effects in female

Reported by a physician from Botswana on 2012-06-01

Patient: female

Reactions: Anaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Kaletra

Other drugs received by patient: Lamivudine + Zidovudine



Possible Kaletra side effects in 67 year old male

Reported by a physician from Greece on 2012-05-30

Patient: 67 year old male

Reactions: Superinfection, Acute Hepatic Failure, Hepatitis D, Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Kaletra
    Indication: Hepatitis B

Kaletra
    Indication: HIV Infection

Other drugs received by patient: Tenofovir + Emtricitabine (Truvanta); Steroids; Methotrexate; Tenofovir + Emtricitabine (Truvanta); Remicade; Emtricitabine



Possible Kaletra side effects in 67 year old male

Reported by a physician from Greece on 2012-05-07

Patient: 67 year old male

Reactions: Superinfection, Acute Hepatic Failure, Hepatitis D, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Kaletra
    Indication: HIV Infection

Kaletra
    Indication: Hepatitis B

Other drugs received by patient: Remicade; Emtricitabine; Methotrexate; Steroids; Tenofovir + Emtricitabine (Truvanta); Tenofovir + Emtricitabine (Truvanta)



Possible Kaletra side effects in 52 year old male

Reported by a physician from United Kingdom on 2012-05-07

Patient: 52 year old male, weighing 68.0 kg (149.6 pounds)

Reactions: Weight Decreased, Renal Cancer Metastatic, Lymphadenopathy, Lung Neoplasm, Renal Mass, Metastases To Bone, Metastases To Lung

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Kaletra

Other drugs received by patient: Abacavir Sulfate / Lamivudine; Opioids; Analgesia



Possible Kaletra side effects in 52 year old male

Reported by a physician from United Kingdom on 2012-05-02

Patient: 52 year old male, weighing 68.0 kg (149.6 pounds)

Reactions: Weight Decreased, Renal Cancer Metastatic, Lymphadenopathy, Lung Neoplasm, Metastases To Bone, Renal Mass, Metastases To Lung

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Kaletra

Other drugs received by patient: Analgesia; Abacavir Sulfate / Lamivudine; Opioids



Possible Kaletra side effects in 42 year old male

Reported by a physician from Germany on 2012-04-30

Patient: 42 year old male, weighing 54.0 kg (118.8 pounds)

Reactions: Ruptured Cerebral Aneurysm, Subarachnoid Haemorrhage, Hemiparesis, Cerebrovascular Spasm

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Kaletra

Other drugs received by patient: Raltegravir



Possible Kaletra side effects in 67 year old male

Reported by a physician from Greece on 2012-04-12

Patient: 67 year old male

Reactions: Superinfection, Acute Hepatic Failure, Hepatitis D, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Kaletra
    Indication: HIV Infection

Kaletra
    Indication: Hepatitis B

Other drugs received by patient: Tenofovir + Emtricitabine (Truvanta); Tenofovir + Emtricitabine (Truvanta); Remicade; Steroids; Methotrexate



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