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Prezista (Darunavir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Prezista (Darunavir) 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 (389)
Death (45)
Life Threatening Events (28)
Disability (17)

Reports by Reaction Type

Maternal Exposure During Pregnancy (33)Foetal Exposure During Pregnancy (20)Pyrexia (19)Abortion Spontaneous (16)Rash (16)Renal Failure Acute (14)Premature Baby (14)Foetal Growth Restriction (13)Depression (13)Gamma-Glutamyltransferase Increased (12)Alanine Aminotransferase Increased (12)Stevens-Johnson Syndrome (11)

Below are a few examples of reports where side effects / adverse reactions may be related to Prezista (Darunavir). For a complete list or a specific selection of reports, please use the links above.

Possible Prezista side effects in male

Reported by a physician from France on 2012-08-27

Patient: male

Reactions: Eyelid Oedema, Lymphadenopathy, Skin Exfoliation, Conjunctivitis, Tachycardia, Scab, Pyrexia, Cheilitis, Penile Ulceration, Face Oedema, Scrotal Oedema, Optic Disc Haemorrhage, Myocarditis, Stevens-Johnson Syndrome, Dysphagia, N-Terminal Prohormone Brain Natriuretic Peptide Increased, Troponin Increased, LIP Haemorrhage, Drug Rash With Eosinophilia and Systemic Symptoms, Anal Erosion, Mucosal Erosion, Cardiac Failure, Cytomegalovirus Chorioretinitis, Epidermal Necrosis, Electrocardiogram Abnormal, Oedema Genital, Rash Maculo-Papular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Dosage: 1unit per day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2012-06-12
    End date: 2012-07-05

Combivir
    Dosage: 1tab twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Dosage: 400mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Dosage: 6g per day
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09

Other drugs received by patient: Malocide; Folinate



Possible Prezista side effects in 18 year old female

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

Patient: 18 year old female

Reactions: Amniotic Fluid Volume Decreased, Maternal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Etravirine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Ritonavir
    Administration route: Oral
    Indication: HIV Infection
    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 France on 2012-08-27

Patient: female

Reactions: Immune Reconstitution Syndrome, Condition Aggravated, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Intelence
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-01-13
    End date: 2012-08-02

Interleukins
    Indication: Progressive Multifocal Leukoencephalopathy
    Start date: 2012-06-21
    End date: 2012-07-05

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-01-13
    End date: 2012-08-02

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-01-13
    End date: 2012-08-02

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-01-13
    End date: 2012-08-02



Possible Prezista side effects in male

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

Patient: male

Reactions: Haemoglobin Decreased, Drug Rash With Eosinophilia and Systemic Symptoms, Blood Sodium Decreased, Myocarditis, Blood Creatinine Increased, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2012-06-12
    End date: 2012-07-05

Combivir
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Norvir
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Dosage: 2 tablets at 400 mg a day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09



Possible Prezista side effects in female

Reported by a physician from France on 2012-08-27

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Pancytopenia, Myelodysplastic Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-11-14
    End date: 2012-06-06

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-03

Valganciclovir
    Administration route: Oral
    Indication: Cytomegalovirus Infection
    Start date: 2012-03-09
    End date: 2012-03-30

Other drugs received by patient: Epivir; Isentress; Norvir; Fluconazole



Possible Prezista side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 130.2 kg (286.4 pounds)

Reactions: Maternal Exposure During Pregnancy, Gestational Diabetes

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prezista

Other drugs received by patient: Norvir; Zantac; Combivir; Aldomet



Possible Prezista side effects in 35 year old male

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

Patient: 35 year old male

Reactions: Renal Impairment, Cytomegalovirus Chorioretinitis, Hypoaesthesia, Mycobacterium Avium Complex Infection, Hyperuricaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-11
    End date: 2010-09-20

Mycobutin
    Administration route: Oral
    Indication: Mycobacterium Avium Complex Infection
    Start date: 2009-11-20
    End date: 2009-12-11

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2011-03-31

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-03
    End date: 2011-03-31

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Valganciclovir
    Administration route: Oral
    Indication: Cytomegalovirus Chorioretinitis
    Start date: 2010-05-19
    End date: 2010-06-30

Valganciclovir
    Administration route: Oral
    Start date: 2010-07-01
    End date: 2011-01-20

Valganciclovir
    Administration route: Oral
    Indication: Cytomegalovirus Infection
    Start date: 2010-01-06
    End date: 2010-06-30

Valganciclovir
    Administration route: Oral
    Indication: Mycobacterium Avium Complex Infection
    Start date: 2010-02-16
    End date: 2010-03-24

Other drugs received by patient: Isentress; Pentamidine Isethionate; Intelence; Semen Coicis; Clindamycin Phosphate; Chlorhexidine Gluconate



Possible Prezista side effects in male

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

Patient: male

Reactions: Dysphagia, Cytomegalovirus Chorioretinitis, Drug Hypersensitivity, Conjunctivitis, Drug Rash With Eosinophilia and Systemic Symptoms, Myocarditis, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Administration route: Oral
    Indication: Pneumocystis Jiroveci Pneumonia
    Start date: 2012-06-12
    End date: 2012-07-05

Bactrim
    Indication: Prophylaxis

Combivir
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09



Possible Prezista side effects in

Reported by a physician from France on 2012-08-23

Patient:

Reactions: Body FAT Disorder, Osteoporosis, Osteopenia, Blood Glucose Increased

Drug(s) suspected as cause:
Nucleoside Reverse Transcriptase Inhibitors
    Indication: HIV Infection

Prezista
    Administration route: Oral
    Indication: HIV Infection

Prezista
    Administration route: Oral

Ritonavir
    Indication: HIV Infection

Ritonavir



Possible Prezista side effects in 54 year old male

Reported by a physician from France on 2012-08-23

Patient: 54 year old male

Reactions: Fanconi Syndrome, Mitochondrial Cytopathy, Drug Interaction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Isentress
    Dosage: film coated
    Administration route: Oral
    Start date: 2011-05-27
    End date: 2011-06-01

Norvir
    Administration route: Oral
    Start date: 2011-06-01

Prezista
    Administration route: Oral
    End date: 2011-06-01

Other drugs received by patient possibly interacting with the suspect drug:
Videx
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Viread
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Other drugs received by patient: Sertraline Hydrochloride; Clomipramine HCL; Aspirin; Crestor; Omeprazole



Possible Prezista side effects in 58 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient: 58 year old male

Reactions: Tachycardia, Transferrin Decreased, Cerebral Toxoplasmosis, Transferrin Saturation Decreased, Eye Haemorrhage, Gamma-Glutamyltransferase Increased, Blood Sodium Decreased, Myocarditis, Electrocardiogram Repolarisation Abnormality, Stevens-Johnson Syndrome, Blood Iron Decreased, Blood Lactate Dehydrogenase Increased, Renal Cyst, Drug Rash With Eosinophilia and Systemic Symptoms, Nephrotic Syndrome, Renal Failure, Cytomegalovirus Chorioretinitis, Electrocardiogram ST Segment Elevation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Dosage: 1 tablet, 1x/day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2012-06-12
    End date: 2012-07-05

Combivir
    Dosage: 1 df, 2x/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Norvir
    Dosage: 100 mg, 1x/day (1 df)
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Dosage: 400 mg, 1x/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Dosage: 6 g, 1x/day
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09

Other drugs received by patient: Malocide; Malocide; Calcium Folinate; Malocide



Possible Prezista side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient:

Reactions: Fanconi Syndrome, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Intelence
    Dosage: 200 mg, bid
    Administration route: Oral

Isentress
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Norvir
    Dosage: unk
    Administration route: Oral
    End date: 2011-06-01

Prezista
    Dosage: 400 mg, bid
    Administration route: Oral
    End date: 2011-06-01

Videx
    Dosage: unk
    Administration route: Oral
    End date: 2011-05-27

Viread
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Other drugs received by patient: [composition Unspecified]; Aspirin; Crestor; Clomipramine Hydrochloride; Omeprazole



Possible Prezista side effects in

Reported by a physician from Japan on 2012-08-22

Patient:

Reactions: Diabetes Mellitus, Hypertriglyceridaemia

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Epivir
    Dosage: 150 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-09-16
    End date: 2006-02-28

Epivir
    Dosage: 150 mg, bid
    Administration route: Oral
    Start date: 2008-12-16

Intelence
    Dosage: 200 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-11

Isentress
    Dosage: 800 mg divided dose frequency u
    Administration route: Oral
    Start date: 2008-08-05

Kaletra
    Dosage: 4 df
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2007-07-04
    End date: 2008-01-08

Prezista
    Dosage: 1200 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-01-09
    End date: 2008-05-01

Truvada
    Dosage: 1 df, unk
    Administration route: Oral
    Start date: 2008-08-05
    End date: 2008-12-15

Truvada
    Dosage: 1df
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2007-07-04
    End date: 2008-05-01

Zerit
    Dosage: 60 mg divided dose frequency u
    Administration route: Oral
    Start date: 2008-12-16
    End date: 2009-02-10

Zerit
    Dosage: 80 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-09-16
    End date: 2006-02-28

Other drugs received by patient: Rhythmy



Possible Prezista side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient: male

Reactions: Multi-Organ Failure, Fanconi Syndrome, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Intelence
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Norvir
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Prezista
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-06-01

Videx
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Viread
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Other drugs received by patient: Omeprazole; Clomipramine HCL; Crestor; Aspirin; Unknown Medication



Possible Prezista side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient:

Reactions: Multi-Organ Failure, Metabolic Acidosis, Fanconi Syndrome, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Intelence
    Dosage: 200 mg, bid
    Administration route: Oral

Isentress
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Norvir
    Dosage: unk
    Administration route: Oral
    End date: 2011-06-01

Prezista
    Dosage: 400 mg, bid
    Administration route: Oral
    End date: 2011-06-01

Videx
    Dosage: unk
    Administration route: Oral
    End date: 2011-05-27

Viread
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Other drugs received by patient: Crestor; Omeprazole; [composition Unspecified]; Aspirin; Clomipramine Hydrochloride



Possible Prezista side effects in female

Reported by a physician from Sweden on 2012-08-22

Patient: female

Reactions: Cholelithiasis

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Indication: Product Used FOR Unknown Indication

Norvir Film-Coated Tablet
    Indication: Product Used FOR Unknown Indication

Prezista
    Indication: Product Used FOR Unknown Indication



Possible Prezista side effects in male

Reported by a physician from Japan on 2012-08-22

Patient: male, weighing 48.0 kg (105.6 pounds)

Reactions: Death, Renal Impairment, Anaemia, Oedema, Fall, Cerebral Haemorrhage Traumatic

Adverse event resulted in: death

Drug(s) suspected as cause:
Isentress
    Dosage: 800mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-10
    End date: 2012-07-06

Maraviroc
    Dosage: 300mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-10
    End date: 2012-07-06

Norvir
    Dosage: 200mg per day
    Administration route: Oral
    Start date: 2012-05-10
    End date: 2012-07-06

Norvir
    Dosage: 200mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-10
    End date: 2012-07-06

Prezista
    Dosage: 1200mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-10
    End date: 2012-07-06

Other drugs received by patient: Mexitil; Intelence; Olmesartan Medoxomil; Coniel; Clonazepam; Reyataz



Possible Prezista side effects in

Reported by a physician from Thailand on 2012-08-21

Patient:

Reactions: Creatinine Renal Clearance Decreased

Drug(s) suspected as cause:
Intelence
    Indication: HIV Infection

Prezista
    Indication: HIV Infection

Ritonavir
    Indication: HIV Infection



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 36 year old female

Reported by a physician from Spain on 2012-08-21

Patient: 36 year old female

Reactions: Abdominal Pain, Hypertensive Encephalopathy, Left Ventricular Hypertrophy

Drug(s) suspected as cause:
Abacavir
    Indication: HIV Infection
    Start date: 2010-08-01

Clonazepam
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-01

Intelence
    Indication: HIV Infection
    Start date: 2010-08-01

Pentamidine
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-01

Prezista
    Indication: HIV Infection
    Start date: 2010-08-01

Raltegravir
    Indication: HIV Infection
    Start date: 2010-08-01

Ritonavir
    Indication: HIV Infection
    Start date: 2010-08-01



Possible Prezista side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Rash Pruritic

Drug(s) suspected as cause:
Multivitamin
    Dosage: i qd, po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-06-01

Norvir

Prezista
    Dosage: ii qd, po
    Administration route: Oral

Truvada



Possible Prezista side effects in male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-20

Patient: male

Reactions: Pruritus, Rash

Drug(s) suspected as cause:
Escitalopram
    Dosage: 1 df
    Administration route: Oral
    Indication: Depression
    Start date: 2012-04-01

Prezista
    Dosage: 300 mg
    Administration route: Oral
    Indication: HIV Infection CDC Category A1
    Start date: 2012-04-12
    End date: 2012-04-23

Truvada
    Dosage: 200 mg/245 mg
    Administration route: Oral
    Indication: HIV Infection CDC Category A1
    Start date: 2012-04-12
    End date: 2012-05-09

Other drugs received by patient: Norvir



Possible Prezista side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-20

Patient: female

Reactions: Oedema Peripheral, Paraesthesia

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Dosage: 600mg/300mg
    Administration route: Oral
    Indication: HIV Infection CDC Category B2
    Start date: 2011-12-20
    End date: 2012-03-05

Norvir
    Administration route: Oral
    Indication: HIV Infection CDC Category B2
    Start date: 2011-12-20
    End date: 2012-03-05

Norvir
    Administration route: Oral
    Start date: 2006-04-06
    End date: 2011-12-20

Norvir
    Administration route: Oral
    Start date: 2012-05-21

Norvir
    Administration route: Oral
    Start date: 2003-01-01

Prezista
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-20
    End date: 2012-03-05

Other drugs received by patient: Nexium; Vitamin D; Ezetimibe; Levocarnil



Possible Prezista side effects in female

Reported by a physician from France on 2012-08-20

Patient: female

Reactions: Hyperaesthesia, Oedema Peripheral, Paraesthesia

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Administration route: Oral
    Indication: HIV Infection CDC Category B2
    Start date: 2011-12-20

Prezista
    Administration route: Oral
    Indication: HIV Infection CDC Category B2
    Start date: 2011-12-20

Other drugs received by patient: Norvir; Nexium; Viread; Levocarnil; Vitamin D; Invirase; Ezetimibe; Epivir



Possible Prezista side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient:

Reactions: Cystic Lymphangioma, Maternal Exposure During Pregnancy, Abortion Spontaneous

Adverse event resulted in: death

Drug(s) suspected as cause:
Edurant
    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 physician from Germany on 2012-08-16

Patient: female, weighing 98.0 kg (215.6 pounds)

Reactions: Maternal Exposure During Pregnancy, Foetal Death, Blood Glucose Fluctuation, Treatment Noncompliance

Drug(s) suspected as cause:
Norvir
    Indication: HIV Infection
    Start date: 2011-10-21

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-10-21

Truvada
    Indication: HIV Infection
    Start date: 2011-10-21



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 32 year old female

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

Patient: 32 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiviral Treatment

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Antiviral Treatment

Prezista
    Dosage: 800mg per day
    Administration route: Oral
    Indication: Antiviral Treatment



Possible Prezista side effects in male

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

Patient: male

Reactions: Pruritus, Rash

Drug(s) suspected as cause:
Escitalopram
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Depression
    Start date: 2012-04-01

Prezista
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: HIV Infection CDC Category A1
    Start date: 2012-04-12
    End date: 2012-04-23

Truvada
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection CDC Category A1
    Start date: 2012-04-12
    End date: 2012-05-09

Other drugs received by patient: Norvir



Possible Prezista 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

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