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Isentress (Raltegravir) - Foetal Exposure During Pregnancy - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Foetal Exposure During Pregnancy (47)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Isentress (Raltegravir) 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 47   Next >>

Possible Isentress side effects in

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

Patient:

Reactions: Foetal Chromosome Abnormality, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Vertical Talus

Drug(s) suspected as cause:
Truvada
    Dosage: 1 df, unk
    Start date: 2011-07-13
    End date: 2011-10-27

Reyataz
    Dosage: 300 mg, qd
    Start date: 2011-07-13
    End date: 2011-10-27

Combivir
    Dosage: 2 df, unk
    Start date: 2011-11-21

Norvir
    Dosage: 100 mg, qd
    Start date: 2011-07-13
    End date: 2011-10-27

Isentress
    Dosage: 800 mg, qd
    Start date: 2011-11-21



Possible Isentress side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Volvulus, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Lamivudine; Kaletra; Nevirapine; Zidovudine; Tenofovir Disoproxil Fumarate



Possible Isentress 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 Isentress side effects in male

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

Patient: male

Reactions: Pneumonia, Foetal Exposure During Pregnancy, Respiratory Distress

Adverse event resulted in: hospitalization

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

Norvir
    Indication: Maternal Exposure Timing Unspecified

Prezista
    Indication: Maternal Exposure Timing Unspecified

Isentress
    Indication: Maternal Exposure Timing Unspecified



Possible Isentress side effects in

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient:

Reactions: Foetal Exposure During Pregnancy, Plagiocephaly

Drug(s) suspected as cause:
Isentress

Combivir



Possible Isentress 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 Isentress side effects in

Reported by a physician from United Kingdom on 2012-08-15

Patient:

Reactions: Polydactyly, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress
    Dosage: unk
    Start date: 2012-01-01

[therapy Unspecified]

Maraviroc
    Dosage: unk
    Start date: 2012-01-01



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-14

Patient:

Reactions: Polydactyly, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress
    Indication: Antiviral Treatment
    Start date: 2012-01-01

Selzentry
    Indication: Antiviral Treatment
    Start date: 2012-01-01



Possible Isentress side effects in male

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

Patient: male, weighing 2.6 kg (5.7 pounds)

Reactions: LOW SET Ears, Foetal Exposure During Pregnancy, Congenital Osteodystrophy, Nasal Disorder, Facial Asymmetry, Microstomia

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiviral Treatment
    Start date: 2009-07-07

Isentress
    Dosage: 800mg per day
    Indication: Antiviral Treatment
    Start date: 2009-07-07



Possible Isentress side effects in

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

Patient:

Reactions: Nose Deformity, Chromosomal Mutation, LOW SET Ears, Foetal Exposure During Pregnancy, Microstomia, Facial Asymmetry

Drug(s) suspected as cause:
Isentress
    Dosage: 800 mg, qd
    Administration route: Oral
    Start date: 2009-07-07

Combivir
    Dosage: 2 df, unk
    Administration route: Oral
    Start date: 2009-07-07



Possible Isentress side effects in

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

Patient:

Reactions: Volvulus, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Lamivudine; Zidovudine; Nevirapine; Kaletra; Tenofovir Disoproxil Fumarate



Possible Isentress side effects in

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

Patient:

Reactions: Foetal Chromosome Abnormality, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Vertical Talus

Drug(s) suspected as cause:
Truvada
    Dosage: 1 df, unk
    Start date: 2011-07-13
    End date: 2011-10-27

Combivir
    Dosage: 2 df, unk
    Start date: 2011-11-21

Norvir
    Dosage: 100 mg, qd
    Start date: 2011-07-13
    End date: 2011-10-27

Reyataz
    Dosage: 300 mg, qd
    Start date: 2011-07-13
    End date: 2011-10-27

Isentress
    Dosage: 800 mg, qd
    Start date: 2011-11-21



Possible Isentress 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 Isentress side effects in

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient:

Reactions: LOW Birth Weight Baby, Foetal Growth Restriction, Small FOR Dates Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Norvir
    Dosage: 200 mg, qd
    Start date: 2011-11-15
    End date: 2012-05-16

Prezista
    Dosage: 1200 mg, qd
    Start date: 2011-11-15
    End date: 2012-05-16

Epzicom
    Dosage: 1 df, qd
    Start date: 2011-11-15
    End date: 2012-05-16

Retrovir
    Dosage: 2000 mg, qd
    Start date: 2011-11-15
    End date: 2012-05-16

Isentress
    Dosage: 800 mg, qd
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Intelence
    Dosage: 400 mg, qd
    Start date: 2011-11-15
    End date: 2012-05-16



Possible Isentress side effects in

Reported by a physician from United Kingdom on 2012-07-20

Patient:

Reactions: Volvulus, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Zidovudine; Kaletra; Nevirapine; Lamivudine; Tenofovir



Possible Isentress side effects in

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

Patient:

Reactions: Polydactyly, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress
    Dosage: unk
    Start date: 2012-01-01

Maraviroc
    Dosage: unk
    Start date: 2012-01-01

[therapy Unspecified]



Possible Isentress side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-22

Patient: female, weighing 1.0 kg (2.2 pounds)

Reactions: Foetal Growth Restriction, LOW Birth Weight Baby, Small FOR Dates Baby, Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Intelence; Norvir; Retrovir; Prezista; Epzicom



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-06-21

Patient:

Reactions: Foetal Exposure During Pregnancy, Plagiocephaly

Drug(s) suspected as cause:
Isentress

Combivir



Possible Isentress side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21

Patient: female

Reactions: Foetal Growth Restriction, Small FOR Dates Baby, Foetal Exposure During Pregnancy

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

Retrovir
    Indication: Maternal Exposure Timing Unspecified

Intelence
    Indication: Maternal Exposure Timing Unspecified

Norvir
    Indication: Maternal Exposure Timing Unspecified

Epzicom
    Indication: Maternal Exposure Timing Unspecified

Isentress
    Indication: Maternal Exposure Timing Unspecified



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-19

Patient:

Reactions: Foetal Chromosome Abnormality, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Vertical Talus

Drug(s) suspected as cause:
Combivir

Truvada

Reyataz

Isentress

Norvir



Possible Isentress side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-21

Patient: female

Reactions: Premature Baby, Foetal Exposure During Pregnancy

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

Isentress
    Indication: Maternal Exposure Timing Unspecified



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-05-18

Patient:

Reactions: Foetal Exposure During Pregnancy, Plagiocephaly

Drug(s) suspected as cause:
Isentress

Combivir



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-09

Patient:

Reactions: Foetal Chromosome Abnormality, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Vertical Talus

Drug(s) suspected as cause:
Norvir

Truvada

Combivir

Reyataz

Isentress



Possible Isentress side effects in

Reported by a physician from France on 2012-05-08

Patient:

Reactions: Underweight, Foetal Exposure During Pregnancy, Heart Disease Congenital

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Lamivudine and Zidovudine



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-01

Patient:

Reactions: Foetal Chromosome Abnormality, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Vertical Talus

Drug(s) suspected as cause:
Truvada

Reyataz

Norvir

Isentress

Combivir



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-26

Patient:

Reactions: Foetal Chromosome Abnormality, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Vertical Talus

Drug(s) suspected as cause:
Truvada

Isentress

Combivir

Norvir

Reyataz



Possible Isentress side effects in male

Reported by a physician from United Kingdom on 2012-04-20

Patient: male, weighing 3.0 kg (6.6 pounds)

Reactions: Volvulus, Caesarean Section, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Nevirapine; Tenofovir; Lamivudine; Lopinavir and Ritonavir; Zidovudine



Possible Isentress side effects in female

Reported by a consumer/non-health professional from Portugal on 2012-04-20

Patient: female, weighing 1.0 kg (2.2 pounds)

Reactions: LOW Birth Weight Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Emtricitabine and Tenofovir Disoproxil Fumarate; Etravirine



Possible Isentress side effects in

Reported by a physician from Italy on 2012-04-17

Patient:

Reactions: Trisomy 21, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Tenofovir Disoproxil Fumarate; Lopinavir and Ritonavir; Lamivudine and Zidovudine; Atazanavir Sulfate



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-12

Patient:

Reactions: Trisomy 21, Abortion, Foetal Exposure During Pregnancy

Adverse event resulted in: death

Drug(s) suspected as cause:
Tenofovir Disoproxil Fumarate
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Combivir
    Indication: Maternal Exposure Timing Unspecified

Isentress
    Indication: Maternal Exposure Timing Unspecified



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