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

 
 



Index of reports > Cases with Maternal Exposure During Pregnancy (134)

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

 Reports 1 - 30 of 134   Next >>

Possible Kaletra side effects in female

Reported by a physician from France on 2012-08-24

Patient: female

Reactions: Cholestasis of Pregnancy, Maternal Exposure During Pregnancy, Adverse Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiviral Prophylaxis
    Start date: 2012-03-05
    End date: 2012-03-19

Combivir
    Dosage: 1tab twice per day
    Administration route: Oral
    Indication: Antiviral Prophylaxis
    Start date: 2012-03-19
    End date: 2012-05-24

Kaletra
    Dosage: 2tab twice per day
    Administration route: Oral
    Indication: Antiviral Prophylaxis
    Start date: 2012-03-19
    End date: 2012-05-24



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 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 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 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 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 26 year old female

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

Patient: 26 year old female

Reactions: Maternal Exposure During Pregnancy, Premature Labour, Congenital Anomaly in Offspring

Adverse event resulted in: death

Drug(s) suspected as cause:
Combivir
    Dosage: unk
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-04-21
    End date: 2011-09-15

Kaletra
    Dosage: unk
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-04-21
    End date: 2011-04-28

Norvir
    Dosage: 200mg/day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-04-28
    End date: 2011-05-10

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

Prezista
    Dosage: 800mg/day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-04-28

Zidovudine
    Dosage: 2.0 mg/day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-15
    End date: 2011-09-15



Possible Kaletra side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Combivir
    Dosage: 2 df, unk
    Administration route: Oral
    Start date: 2012-05-28

Isentress
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2012-03-28
    End date: 2012-05-23

Kaletra
    Dosage: 4 df, unk
    Administration route: Oral
    Start date: 2012-05-28

Viread
    Dosage: 300 mg, qd
    Administration route: Oral
    Start date: 2012-03-28
    End date: 2012-05-23



Possible Kaletra side effects in 26 year old female

Reported by a physician from Uganda on 2012-08-10

Patient: 26 year old female

Reactions: Stillbirth, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-22

Lamivudine + Zidovudine
    Dosage: 4tabs per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-22



Possible Kaletra side effects in 29 year old female

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

Patient: 29 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Induced

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

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



Possible Kaletra side effects in 37 year old female

Reported by a physician from Uganda on 2012-08-09

Patient: 37 year old female

Reactions: Maternal Exposure During Pregnancy, Stillbirth

Drug(s) suspected as cause:
Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-02-21

Lamivudine + Zidovudine
    Dosage: 2tab per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-02-21



Possible Kaletra side effects in 37 year old female

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

Patient: 37 year old female

Reactions: Endometrial Disorder, Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Epivir
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-09-21

Kaletra
    Dosage: 4tab unknown
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-09-21

Viread
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-09-21



Possible Kaletra side effects in 28 year old female

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

Patient: 28 year old female

Reactions: Transient Tachypnoea of THE Newborn, Maternal Exposure During Pregnancy, Gestational Diabetes, Herpes Virus Infection

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-10-06

Kaletra
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-10-06
    End date: 2011-11-10

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-11-10

Prezista
    Dosage: 800mg per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-11-10

Other drugs received by patient: Multi-Vitamins



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 23 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: 23 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous, Ill-Defined Disorder

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 35 year old female

Reported by a physician from Mexico on 2012-08-06

Patient: 35 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-05-28

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-05-28

Raltegravir
    Dosage: 400mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-28
    End date: 2012-05-23

Viread
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-28
    End date: 2012-05-23



Possible Kaletra side effects in 22 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: 22 year old female

Reactions: Blighted Ovum, Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-06-11

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-06-11



Possible Kaletra side effects in 22 year old female

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

Patient: 22 year old female

Reactions: Maternal Exposure During Pregnancy, Blighted Ovum, Abortion Spontaneous

Drug(s) suspected as cause:
Combivir
    Dosage: 2 tabs/caps daily, course #1
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-06-11

Kaletra
    Dosage: 4 tabs/caps daily; course #1
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-06-11



Possible Kaletra side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient:

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Combivir
    Dosage: unk df, unk
    Administration route: Oral
    Start date: 2012-05-28

Isentress
    Dosage: unk mg, unk
    Administration route: Oral
    Start date: 2012-03-28
    End date: 2012-05-23

Kaletra
    Dosage: unk df, unk
    Administration route: Oral
    Start date: 2012-05-28

Viread
    Dosage: unk mg, unk
    Administration route: Oral
    Start date: 2012-03-28
    End date: 2012-05-23



Possible Kaletra side effects in 22 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient: 22 year old female

Reactions: Maternal Exposure During Pregnancy, Blighted Ovum, Abortion Spontaneous

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-06-11

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-06-11



Possible Kaletra side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient: 30 year old female

Reactions: Maternal Exposure During Pregnancy, Stillbirth

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
    End date: 2011-03-09

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02
    End date: 2011-03-09



Possible Kaletra side effects in 26 year old female

Reported by a health professional (non-physician/pharmacist) from Uganda on 2012-07-26

Patient: 26 year old female

Reactions: Stillbirth, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-22

Lamivudine + Zidovudine
    Dosage: 4tabs per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-22



Possible Kaletra side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from Mexico on 2012-07-23

Patient: 35 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-05-28

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-05-28

Reyataz
    Dosage: 400mg per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-28
    End date: 2012-05-23

Viread
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-28
    End date: 2012-05-23



Possible Kaletra side effects in 21 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: 21 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Atripla
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    End date: 2012-02-20

Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-02-20

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-02-20



Possible Kaletra side effects in 37 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: 37 year old female

Reactions: Endometrial Disorder, Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Epivir
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-09-21

Kaletra
    Dosage: 4tab unknown
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-09-21

Viread
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-09-21



Possible Kaletra side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-20

Patient: 36 year old female

Reactions: Maternal Exposure During Pregnancy, Live Birth, Gestational Diabetes

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-03-22

Kaletra
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-03-22

Lopinavir and Ritonavir
    Indication: Product Used FOR Unknown Indication



Possible Kaletra side effects in 30 year old female

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

Patient: 30 year old female

Reactions: Maternal Exposure During Pregnancy, Stillbirth

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
    End date: 2011-03-09

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02
    End date: 2011-03-09



Possible Kaletra side effects in 44 year old female

Reported by a physician from Thailand on 2012-07-16

Patient: 44 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Epivir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-14

Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-14

Norvir
    Dosage: 150mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-11-03
    End date: 2012-03-12

Reyataz
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-11-03
    End date: 2012-03-12

Truvada
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-11-03
    End date: 2012-03-12

Viread
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-14



Possible Kaletra side effects in 44 year old female

Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-07-03

Patient: 44 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Epivir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-14

Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-14

Norvir
    Dosage: 150mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-11-03
    End date: 2012-03-12

Reyataz
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-11-03
    End date: 2012-03-12

Truvada
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-11-03
    End date: 2012-03-12

Viread
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-14



Possible Kaletra side effects in 25 year old female

Reported by a physician from United Kingdom on 2012-07-02

Patient: 25 year old female

Reactions: Cytolytic Hepatitis, Maternal Exposure During Pregnancy, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-19

Epzicom
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-05
    End date: 2012-03-19

Kaletra
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-05
    End date: 2012-03-19

Norvir
    Dosage: 100mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-13
    End date: 2011-11-08

Prezista
    Dosage: 800mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-13
    End date: 2011-11-08

Raltegravir
    Dosage: 80mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-13
    End date: 2011-11-08

Selzentry
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-13
    End date: 2011-11-08

Truvada
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-13
    End date: 2011-11-08



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