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Kaletra (Lopinavir / Ritonavir) - Premature Baby - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Premature Baby (90)

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

 Reports 1 - 30 of 90   Next >>

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 Argentina on 2012-08-21

Patient: male

Reactions: Premature Baby, Foetal Exposure During Pregnancy, Ventricular Septal Defect

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

Lamivudine / Zidovudine
    Indication: Maternal Exposure Timing Unspecified

Nevirapine
    Indication: Maternal Exposure Timing Unspecified

Tenofovir Disoproxil Fumarate
    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



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

Patient: male

Reactions: Premature Baby, Hypotonia Neonatal, Foetal Exposure During Pregnancy, Congenital Myopathy

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

Patient:

Reactions: Congenital Aortic Stenosis, Dandy-Walker Syndrome, Premature Baby, Foetal Exposure During Pregnancy, Congenital Pulmonary Artery Anomaly, Sepsis, Foetal Heart Rate Abnormal, Heart Disease Congenital, Talipes

Adverse event resulted in: death

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: HIV Infection
    Start date: 2010-08-30

Kaletra
    Dosage: 4tab per day
    Indication: HIV Infection
    Start date: 2010-08-30



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 female

Reported by a consumer/non-health professional from Australia on 2012-08-14

Patient: female

Reactions: Normal Newborn, Premature Baby, Foetal Exposure During Pregnancy

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

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in male

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

Patient: male, weighing 2.7 kg (5.9 pounds)

Reactions: Foetal Growth Restriction, Premature Baby, Foetal Exposure During Pregnancy

Adverse event resulted in: death

Drug(s) suspected as cause:
Combivir
    Dosage: unk
    Indication: Maternal Exposure During Pregnancy
    Start date: 2011-04-21
    End date: 2011-09-15

Kaletra
    Dosage: unk
    Indication: Maternal Exposure During Pregnancy
    Start date: 2011-04-21
    End date: 2011-04-28

Norvir
    Dosage: 100 mg/day
    Start date: 2011-05-11

Norvir
    Dosage: 200 mg/day
    Indication: Maternal Exposure During Pregnancy
    Start date: 2011-04-28
    End date: 2011-05-10

Prezista
    Dosage: 800 mg/day
    Indication: Maternal Exposure During Pregnancy
    Start date: 2011-04-28

Zidovudine
    Dosage: 2.0 mg/day
    Indication: Maternal Exposure During Pregnancy
    Start date: 2011-09-15
    End date: 2011-09-15



Possible Kaletra side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient:

Reactions: Dandy-Walker Syndrome, Congenital Aortic Stenosis, Premature Baby, Foetal Exposure During Pregnancy, Sepsis, Congenital Pulmonary Artery Anomaly, Talipes, Heart Disease Congenital, Foetal Heart Rate Abnormal

Adverse event resulted in: death

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: HIV Infection
    Start date: 2010-08-30

Kaletra
    Dosage: 4tab per day
    Indication: HIV Infection
    Start date: 2010-08-30



Possible Kaletra side effects in male

Reported by a physician from United States on 2012-08-09

Patient: male, weighing 2.1 kg (4.6 pounds)

Reactions: Premature Baby, Foetal Exposure During Pregnancy, Rash, Congenital Cytomegalovirus Infection, Foetal Growth Restriction, Microcephaly, Laboratory Test Abnormal, Hepatomegaly, Hypervitaminosis

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-14

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-14
    End date: 2011-12-05

Retrovir
    Indication: Antiretroviral Therapy
    Start date: 2011-12-05
    End date: 2011-12-05



Possible Kaletra side effects in male

Reported by a physician from United States on 2012-08-09

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: Darunavir Ethanolate; Zidovudine; Combivir



Possible Kaletra side effects in male

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

Patient: male, weighing 2.1 kg (4.6 pounds)

Reactions: Atrial Septal Defect, Congenital Anaemia, Cardiac Murmur, Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Jaundice Neonatal, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Other drugs received by patient: Metronidazole



Possible Kaletra side effects in 40 year old female

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

Patient: 40 year old female

Reactions: Premature Rupture of Membranes, Premature Baby, Maternal Exposure During Pregnancy, PRE-Eclampsia

Drug(s) suspected as cause:
Epivir
    Dosage: 600mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-03-22

Intelence
    Dosage: 400mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-04-19
    End date: 2011-06-14

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-06-16

Norvir
    Dosage: 100mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-04-04
    End date: 2011-04-18

Retrovir
    Dosage: 800mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-06-16

Reyataz
    Dosage: 800mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-04-19
    End date: 2011-06-16

Reyataz
    Dosage: 300mgd per day
    Administration route: Oral
    Start date: 2011-04-04
    End date: 2011-04-18



Possible Kaletra side effects in male

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

Patient: male, weighing 2.3 kg (5.1 pounds)

Reactions: Prenatal Screening Test Abnormal, Premature Baby, Foetal Exposure During Pregnancy, Polyhydramnios

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiviral Treatment
    Start date: 2011-03-21

Kaletra
    Dosage: 6tab per day
    Indication: Antiviral Treatment
    Start date: 2011-03-21

Sustiva
    Dosage: 600mg per day
    Indication: Antiviral Treatment
    Start date: 2008-10-01
    End date: 2011-03-21

Truvada
    Dosage: 1tab per day
    Indication: Antiviral Treatment
    Start date: 2008-07-24
    End date: 2011-03-21



Possible Kaletra side effects in male

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

Patient: male, weighing 2.7 kg (5.9 pounds)

Reactions: Foetal Growth Restriction, Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-04-21
    End date: 2011-09-15

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-04-21
    End date: 2011-04-28

Norvir
    Dosage: 200mgd per day
    Indication: Antiretroviral Therapy
    Start date: 2011-04-28
    End date: 2011-05-10

Norvir
    Dosage: 100mgd per day
    Start date: 2011-05-11

Prezista
    Dosage: 800mgd per day
    Indication: Antiretroviral Therapy
    Start date: 2011-04-28

Zidovudine
    Dosage: 2mgd per day
    Indication: Prophylaxis
    Start date: 2011-09-15
    End date: 2011-09-15



Possible Kaletra side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: female

Reactions: Premature Baby, Foetal Exposure During Pregnancy

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Jaundice, Atrial Septal Defect, Cardiac Murmur, Dysmorphism, Premature Baby, Anaemia, Foetal Exposure During Pregnancy, Limb Malformation, 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 male

Reported by a physician from United States on 2012-07-30

Patient: male, weighing 2.1 kg (4.6 pounds)

Reactions: Atrial Septal Defect, Cardiac Murmur, Dysmorphism, Congenital Anaemia, Premature Baby, Foetal Exposure During Pregnancy, Jaundice Neonatal, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Other drugs received by patient: Metronidazole



Possible Kaletra side effects in female

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

Patient: female

Reactions: Immature Respiratory System, Premature Baby, Foetal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kaletra

Other drugs received by patient: Zidovudine; Septra



Possible Kaletra side effects in female

Reported by a physician from United States on 2012-07-24

Patient: female, weighing 1.7 kg (3.7 pounds)

Reactions: Atrial Septal Defect, Hydronephrosis, Pulmonary Valve Stenosis, Premature Baby, Foetal Exposure During Pregnancy, Congenital Renal Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-01-12

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-01-12



Possible Kaletra side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19

Patient: male, weighing 2.1 kg (4.6 pounds)

Reactions: Foetal Growth Restriction, Hepatomegaly, Microcephaly, Laboratory Test Abnormal, Premature Baby, Foetal Exposure During Pregnancy, Rash, Hypervitaminosis, Congenital Cytomegalovirus Infection

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-14

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-14

Kaletra
    Dosage: 6tab per day
    Start date: 2011-09-22
    End date: 2011-12-05

Retrovir
    Indication: Antiretroviral Therapy
    Start date: 2011-12-05
    End date: 2011-12-05



Possible Kaletra side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19

Patient: female

Reactions: Atrial Septal Defect, Hydronephrosis, Premature Baby, Pulmonary Valve Stenosis, Foetal Exposure During Pregnancy, Congenital Renal Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-01-12

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-01-12



Possible Kaletra side effects in male

Reported by a physician from United States on 2012-07-17

Patient: male

Reactions: Atrial Septal Defect, Cardiac Murmur, Congenital Anaemia, Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Jaundice Neonatal, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Other drugs received by patient: Metronidazole



Possible Kaletra side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17

Patient: male

Reactions: Full Blood Count Abnormal, Premature Baby, Foetal Exposure During Pregnancy, Rash, Congenital Cytomegalovirus Infection, Foetal Growth Restriction, Hepatomegaly, Microcephaly, Hypervitaminosis

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 female

Reported by a physician from United States on 2012-07-09

Patient: female

Reactions: Atrial Septal Defect, Hydronephrosis, Premature Baby, Pulmonary Valve Stenosis, Foetal Exposure During Pregnancy, Congenital Renal Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-01-12

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-01-12



Possible Kaletra side effects in female

Reported by a pharmacist from United States on 2012-07-06

Patient: female, weighing 2.2 kg (4.8 pounds)

Reactions: Foetal Exposure During Pregnancy, Accidental Overdose, Electroencephalogram Abnormal, Malaise, Sinoatrial Block, Oxygen Saturation Decreased, Renal Failure Acute, Vomiting, Premature Baby, Blood Potassium Increased, Nodal Rhythm, Toxicity To Various Agents, Cardiogenic Shock, Drug Prescribing Error, Staphylococcal Sepsis, Arrhythmia, Haemoglobin Decreased, Bradycardia, Anion GAP Decreased, Neonatal Respiratory Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Kaletra
    Administration route: Oral
    Indication: Blood HIV RNA
    Start date: 2007-03-29
    End date: 2007-03-29

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Other drugs received by patient: Lamivudine; Ritonavir; Abacavir



Possible Kaletra side effects in male

Reported by a physician from United States on 2012-06-28

Patient: male

Reactions: Atrial Septal Defect, Dysmorphism, Congenital Anaemia, Cardiac Murmur, Premature Baby, Foetal Exposure During Pregnancy, Jaundice Neonatal, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Other drugs received by patient: Metronidazole



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