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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