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 2.6 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 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 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 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
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
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 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 2012-08-14
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 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 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
Page 1 Next >>
|