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Fortovase (Saquinavir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Fortovase (Saquinavir) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (3)
Death (1)

Reports by Reaction Type

Pregnancy (2)Dysmorphism (1)Premature Baby (1)Foetal Exposure During Pregnancy (1)Tachycardia (1)Respiratory Distress (1)Congenital Musculoskeletal Anomaly (1)Trisomy 21 (1)Tachypnoea (1)Congenital Eye Disorder (1)Talipes (1)Hepatosplenomegaly (1)

Possible Fortovase side effects in

Reported by a physician from Nigeria on 2012-08-14

Patient:

Reactions: Pregnancy

Drug(s) suspected as cause:
Fortovase
    Dosage: 1000 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-12-07

Raltegravir
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-03-04
    End date: 2011-12-07

Lopinavir
    Administration route: Oral
    Indication: HIV Infection

Truvada
    Start date: 2008-12-05

Efavirenz
    Start date: 2008-12-05

Kaletra
    Administration route: Oral
    Start date: 2011-03-04

Combivir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-12-07

Other drugs received by patient: Sulfamethoxazole and Trimethoprim; Clotrimazole



Possible Fortovase side effects in

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

Patient:

Reactions: Pregnancy

Drug(s) suspected as cause:
Raltegravir
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-03-04
    End date: 2011-12-07

Fortovase
    Dosage: 1000 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-12-07

Efavirenz
    Start date: 2008-12-05

Lopinavir
    Administration route: Oral
    Indication: HIV Infection

Kaletra
    Administration route: Oral
    Start date: 2011-03-04

Truvada
    Start date: 2008-12-05

Combivir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-12-07

Other drugs received by patient: Sulfamethoxazole and Trimethoprim; Clotrimazole



Possible Fortovase side effects in female

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

Patient: female

Reactions: Dysmorphism, Premature Baby, Tachycardia, Foetal Exposure During Pregnancy, Respiratory Distress, Congenital Musculoskeletal Anomaly, Trisomy 21, Congenital Eye Disorder, Tachypnoea, Talipes, Hepatosplenomegaly

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Kaletra
    Indication: HIV Infection
    Start date: 2011-03-04

Fortovase
    Dosage: 1000mgd per day
    Indication: HIV Infection
    Start date: 2011-12-07

Raltegravir
    Dosage: 800mgd per day
    Indication: HIV Infection
    Start date: 2011-03-04
    End date: 2011-12-07

Combivir
    Indication: HIV Infection
    Start date: 2011-12-07

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