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Prezista (Darunavir) - Foetal Exposure During Pregnancy - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Foetal Exposure During Pregnancy (20)

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

Possible Prezista 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:
Isentress
    Indication: Maternal Exposure Timing Unspecified

Norvir
    Indication: Maternal Exposure Timing Unspecified

Prezista
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Prezista side effects in female

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

Patient: female

Reactions: Foetal Exposure During Pregnancy, Congenital Genital Malformation Female

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

Prezista
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Prezista 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 Prezista 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 Prezista 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:
Epzicom
    Dosage: 1 df, qd
    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

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

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

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



Possible Prezista 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:
Epzicom
    Indication: Maternal Exposure Timing Unspecified

Intelence
    Indication: Maternal Exposure Timing Unspecified

Isentress
    Indication: Maternal Exposure Timing Unspecified

Norvir
    Indication: Maternal Exposure Timing Unspecified

Prezista
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Prezista side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-25

Patient:

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
    End date: 2011-12-20

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
    End date: 2011-12-20

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



Possible Prezista side effects in male

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

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
    Indication: Antiretroviral Therapy
    Start date: 2011-04-28
    End date: 2011-05-10

Prezista
    Dosage: 800mgd per day
    Indication: Antiretroviral Therapy
    Start date: 2011-04-28
    End date: 2011-12-01

Other drugs received by patient: Zidovudine



Possible Prezista side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-14

Patient: female

Reactions: Foetal Exposure During Pregnancy, Congenital Genital Malformation Female

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

Prezista
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Prezista side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-03

Patient:

Reactions: Premature Baby, Congenital Anomaly, Foetal Exposure During Pregnancy

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

Prezista
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Prezista side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-02

Patient: female

Reactions: Foetal Exposure During Pregnancy, Congenital Genital Malformation Female

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

Prezista
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Prezista side effects in female

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

Patient: female

Reactions: Foetal Exposure During Pregnancy, Congenital Genital Malformation Female

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

Prezista
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Prezista side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-05

Patient: female

Reactions: Foetal Exposure During Pregnancy, Congenital Genital Malformation Female

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

Prezista
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Prezista side effects in male

Reported by a health professional (non-physician/pharmacist) from Portugal on 2012-03-06

Patient: male

Reactions: Pneumonia, Foetal Exposure During Pregnancy, Respiratory Distress

Adverse event resulted in: hospitalization

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

Norvir
    Indication: Maternal Exposure Timing Unspecified

Prezista
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Prezista side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-29

Patient:

Reactions: Foetal Growth Restriction, Maternal Drugs Affecting Foetus, Premature Baby, Foetal Exposure During Pregnancy

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: 2011-05-19

Norvir
    Dosage: 200 mg/day
    Indication: Maternal Exposure Timing Unspecified
    Start date: 2011-04-28
    End date: 2011-05-18

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

Zidovudine
    Dosage: 20 mg/day
    Indication: Maternal Exposure During Pregnancy
    Start date: 2011-09-15
    End date: 2011-09-15



Possible Prezista side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-23

Patient:

Reactions: Umbilical Cord Vascular Disorder, Premature Baby, Foetal Exposure During Pregnancy

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

Norvir
    Indication: Maternal Exposure Timing Unspecified

Prezista
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified

Viramune
    Indication: Maternal Exposure Timing Unspecified



Possible Prezista side effects in male

Reported by a health professional (non-physician/pharmacist) from Portugal on 2012-02-21

Patient: male

Reactions: Pneumonia, Foetal Exposure During Pregnancy, Respiratory Distress

Adverse event resulted in: hospitalization

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

Norvir
    Indication: Maternal Exposure Timing Unspecified

Prezista
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Prezista side effects in male

Reported by a health professional (non-physician/pharmacist) from Portugal on 2012-01-24

Patient: male

Reactions: Pneumonia, Foetal Exposure During Pregnancy, Respiratory Distress

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

Norvir
    Indication: Maternal Exposure Timing Unspecified

Prezista
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Prezista side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-19

Patient: female, weighing 2.4 kg (5.3 pounds)

Reactions: Foetal Growth Restriction, Ultrasound Scan Abnormal, Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Combivir
    Dosage: 200mg per day
    Indication: Antiviral Treatment
    Start date: 2010-01-12
    End date: 2010-06-03

Norvir
    Dosage: 200mg per day
    Indication: Antiviral Treatment
    Start date: 2010-02-18

Prezista
    Dosage: 1200mg per day
    Indication: Antiviral Treatment
    Start date: 2010-02-18

Other drugs received by patient: Retrovir



Possible Prezista side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-02

Patient: male, weighing 0.4 kg (0.9 pounds)

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

Drug(s) suspected as cause:
Combivir
    Dosage: transplacental
    Indication: Antiviral Treatment
    Start date: 2011-04-21
    End date: 2011-09-15

Kaletra
    Dosage: transplacental
    Indication: Antiviral Treatment

Norvir
    Dosage: 200 mg, 1 d, transplacental; 100 mg, 1 d, oral
    Indication: Antiviral Treatment
    Start date: 2011-05-19

Norvir
    Dosage: 200 mg, 1 d, transplacental; 100 mg, 1 d, oral
    Indication: Antiviral Treatment
    Start date: 2011-04-28
    End date: 2011-05-18

Prezista
    Dosage: 800 mg, 1 d, transplacental
    Indication: Antiviral Treatment
    Start date: 2011-04-28

Zidovudine
    Dosage: transplacental
    Indication: Antiviral Treatment
    Start date: 2011-09-15
    End date: 2011-09-15

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