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Kaletra (Lopinavir / Ritonavir) - Foetal Exposure During Pregnancy - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Foetal Exposure During Pregnancy (238)

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

 Reports 1 - 30 of 238   Next >>

Possible Kaletra side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: Ultrasound Scan Abnormal, Foetal Exposure During Pregnancy, Abortion Induced, Talipes, Meningomyelocele

Adverse event resulted in: death

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in 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 United States on 2012-08-24

Patient: male

Reactions: Cleft LIP and Palate, Foetal Exposure During Pregnancy

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

Truvada
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male, weighing 2.7 kg (5.9 pounds)

Reactions: Foetal Exposure During Pregnancy, Ventricular Septal Defect

Drug(s) suspected as cause:
Kaletra

Other drugs received by patient: Combivir; Retrovir



Possible Kaletra side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male, weighing 2.6 kg (5.7 pounds)

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

Adverse event resulted in: hospitalization

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

Norvir
    Indication: Maternal Exposure Timing Unspecified

Other drugs received by patient: Combivir; Zidovudine; Darunavir Ethanolate



Possible Kaletra side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: male

Reactions: Foetal Exposure During Pregnancy, Congenital Anomaly

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

Combivir
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: male

Reactions: Volvulus, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Zidovudine
    Dosage: unk
    Indication: Maternal Exposure During Pregnancy
    End date: 2010-06-10

Tenofovir Disoproxil Fumarate
    Dosage: unk
    Indication: Maternal Exposure During Pregnancy
    Start date: 2010-06-10

Isentress
    Dosage: 800 mg/day
    Indication: Maternal Exposure During Pregnancy
    Start date: 2010-06-10

Nevirapine
    Dosage: unk
    Indication: Maternal Exposure During Pregnancy
    End date: 2010-06-10

Kaletra
    Dosage: unk
    Indication: Maternal Exposure During Pregnancy
    Start date: 2010-06-10

Lamivudine
    Dosage: unk
    Indication: Maternal Exposure During Pregnancy
    End date: 2010-06-10



Possible Kaletra side effects in female

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

Patient: female

Reactions: Atrial Septal Defect, Cardiac Murmur, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Pyelocaliectasis

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

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in

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

Patient:

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

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in male

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

Patient: male

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

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

Tenofovir Disoproxil Fumarate
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Lamivudine / Zidovudine
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in

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

Patient:

Reactions: Ultrasound Scan Abnormal, Foetal Exposure During Pregnancy, Abortion Induced, Talipes, Meningomyelocele

Adverse event resulted in: death

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

Combivir
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in

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

Patient:

Reactions: Foetal Exposure During Pregnancy, Ultrasound Antenatal Screen Abnormal

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 2012-08-17

Patient: male

Reactions: Volvulus, Foetal Exposure During Pregnancy

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

Isentress
    Indication: Maternal Exposure Timing Unspecified

Zidovudine
    Indication: Maternal Exposure Timing Unspecified

Tenofovir Disoproxil Fumarate
    Indication: Maternal Exposure Timing Unspecified

Lamivudine
    Indication: Maternal Exposure Timing Unspecified

Nevirapine
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in male

Reported by a physician from United States on 2012-08-17

Patient: male, weighing 2.9 kg (6.4 pounds)

Reactions: Prenatal Screening Test Abnormal, Drug Screen Positive, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-10

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-10

Other drugs received by patient: Cocaine; Tetrahydrocannabinol



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:
Kaletra
    Indication: Maternal Exposure Timing Unspecified

Atripla
    Indication: Maternal Exposure Timing Unspecified

Combivir
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in male

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

Patient: male

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

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

Combivir
    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

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, Nervous System Disorder, Foetal Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy

Combivir
    Dosage: 2tab per day
    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: 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:
Kaletra
    Dosage: 4tab per day
    Indication: HIV Infection
    Start date: 2010-08-30

Combivir
    Dosage: 2tab per day
    Indication: HIV Infection
    Start date: 2010-08-30



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:
Retrovir
    Indication: Maternal Exposure Timing Unspecified

Epzicom
    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 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:
Truvada
    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 2012-08-14

Patient:

Reactions: Congenital Central Nervous System Anomaly, Stillbirth, Foetal Exposure During Pregnancy

Adverse event resulted in: death

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

Combivir
    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 United States on 2012-08-14

Patient:

Reactions: Stillbirth, Congenital Central Nervous System Anomaly, Foetal Exposure During Pregnancy, Heart Disease Congenital, Single Umbilical Artery

Adverse event resulted in: death

Drug(s) suspected as cause:
Combivir

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in male

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

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:
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

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

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

Combivir
    Dosage: unk
    Indication: Maternal Exposure During Pregnancy
    Start date: 2011-04-21
    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, Aortic Stenosis, Foetal Exposure During Pregnancy, Congenital Cardiovascular Anomaly, Foetal Monitoring Abnormal, Congenital Pulmonary Artery Anomaly, Sepsis, Talipes, Heart Disease Congenital

Adverse event resulted in: death

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Kaletra side effects in

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

Combivir
    Dosage: 2tab per day
    Indication: HIV Infection
    Start date: 2010-08-30



Possible Kaletra side effects in

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

Patient:

Reactions: Ultrasound Scan Abnormal, Foetal Exposure During Pregnancy, Talipes, Meningomyelocele

Drug(s) suspected as cause:
Combivir
    Indication: Antiretroviral Therapy
    Start date: 2005-12-07

Kaletra
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-06-09



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