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 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 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 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 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 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 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
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 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 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 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 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 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 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
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
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