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

 
 



Index of reports > Serious Reactions (472)

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

 Reports 1 - 30 of 472   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 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 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 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

Lamivudine
    Indication: HIV Infection

Nevirapine
    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 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

Lamivudine
    Indication: HIV Infection

Nevirapine
    Indication: HIV Infection

Zidovudine
    Indication: HIV Infection



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:
Kaletra
    Indication: HIV Infection

Lamivudine
    Indication: HIV Infection

Nevirapine
    Indication: HIV Infection

Zidovudine
    Indication: HIV Infection



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

Lamivudine
    Indication: HIV Infection

Nevirapine
    Indication: HIV Infection

Zidovudine
    Indication: HIV Infection



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:
Isentress
    Dosage: 800 mg/day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-06-10

Kaletra
    Dosage: unk
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-06-10

Lamivudine
    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

Tenofovir Disoproxil Fumarate
    Dosage: unk
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-06-10

Zidovudine
    Dosage: unk
    Administration route: Oral
    Indication: Antiretroviral Therapy
    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 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:
Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-17
    End date: 2011-08-09

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-08-09

Other drugs received by patient: Combivir; Reyataz



Possible Kaletra side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient:

Reactions: Atrial Septal Defect, Jaundice, Cardiac Murmur, Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Anaemia, Ascites, Hydrops Foetalis, Talipes

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-20

Patient: 35 year old female

Reactions: Breech Delivery, Live Birth, Maternal Exposure During Pregnancy, Liver Function Test Abnormal, Nephropathy

Drug(s) suspected as cause:
Epzicom
    Dosage: 1tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-11-25

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-11-25



Possible Kaletra side effects in female

Reported by a pharmacist from France on 2012-08-20

Patient: female

Reactions: Cholestasis of Pregnancy, Gestational Diabetes, Adverse Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-19
    End date: 2012-05-24

Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-19
    End date: 2012-05-24

Other drugs received by patient: Isentress; Truvada



Possible Kaletra side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: male

Reactions: Premature Baby, Foetal Exposure During Pregnancy

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

Combivir
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in male

Reported by a physician from Japan on 2012-08-17

Patient: male

Reactions: Blood Creatinine Increased

Drug(s) suspected as cause:
Kaletra

Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-12-04

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-12-01

Other drugs received by patient: Amlodipine Besylate; Efavirenz



Possible Kaletra side effects in male

Reported by a physician from Japan on 2012-08-17

Patient: male

Reactions: Rhabdomyolysis, Dyspnoea, Hepatic Failure, Lactic Acidosis, Acidosis, Fall, Haematemesis, Haematochezia, Multi-Organ Failure, Spinal Compression Fracture, Fractured Ischium, Melaena, Renal Failure Acute, Hepatic Cirrhosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Kaletra
    Dosage: 4 dosage forms daily
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2007-09-12
    End date: 2011-01-14

Sulfamethoxazole and Trimethoprim
    Indication: Prophylaxis

Sulfamethoxazole and Trimethoprim
    Administration route: Oral
    Indication: Pneumocystis Jiroveci Pneumonia
    End date: 2011-01-14

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-04-27
    End date: 2011-01-14

Other drugs received by patient: Zerit; Lamivudine



Possible Kaletra side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 36 year old female

Reactions: Premature Rupture of Membranes

Drug(s) suspected as cause:
Kaletra
    Dosage: 4 tab/caps daily (taking at conception)
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-01-15

Retrovir
    Dosage: taking at conception
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-01-15

Retrovir
    Dosage: not taking at conception
    Start date: 2011-07-29
    End date: 2011-07-29

Truvada
    Dosage: 1 tab/caps daily (taking at conception)
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-01-15



Possible Kaletra side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 30 year old female

Reactions: Stillbirth, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Cocaine
    Indication: Drug Abuse

Epzicom
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02



Possible Kaletra side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 30 year old female

Reactions: Stillbirth

Drug(s) suspected as cause:
Epzicom
    Dosage: 1 tab/caps daily; not used at conception
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02

Kaletra
    Dosage: 4 tab/caps daily; not used at conception
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02



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

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Foetal Exposure During Pregnancy, Foetal Death, Nervous System Disorder, Heart Disease Congenital, Single Umbilical Artery

Adverse event resulted in: death

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy



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 35 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-15

Patient: 35 year old female

Reactions: Breech Delivery, Maternal Exposure During Pregnancy, Live Birth, Liver Function Test Abnormal, Nephropathy

Drug(s) suspected as cause:
Epzicom
    Dosage: 1tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-11-25

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-11-25



Possible Kaletra side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Foetal Exposure During Pregnancy, Nervous System Disorder, Foetal Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy



Possible Kaletra side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-15

Patient: female, weighing 1.9 kg (4.2 pounds)

Reactions: Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Epzicom
    Indication: Antiretroviral Therapy

Kaletra
    Indication: Antiretroviral Therapy



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 33 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: 33 year old female

Reactions: Stillbirth, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy



Possible Kaletra side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient:

Reactions: Premature Baby, Foetal Exposure During Pregnancy

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



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