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Prezista (Darunavir) - Stevens-Johnson Syndrome - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Stevens-Johnson Syndrome (11)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Prezista (Darunavir) where reactions include stevens-johnson syndrome. 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 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 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 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 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 38 year old female

Reported by a physician from Portugal on 2012-06-12

Patient: 38 year old female

Reactions: Dyspnoea, Stevens-Johnson Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prezista
    Administration route: Oral
    Indication: HIV Infection

Raltegravir
    Indication: HIV Infection

Ritonavir
    Indication: HIV Infection

Other drugs received by patient: Truvada



Possible Prezista side effects in 38 year old female

Reported by a physician from Portugal on 2012-05-24

Patient: 38 year old female

Reactions: Dyspnoea, Stevens-Johnson Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prezista
    Administration route: Oral
    Indication: HIV Infection

Raltegravir
    Indication: HIV Infection

Ritonavir
    Indication: HIV Infection

Other drugs received by patient: Truvada



Possible Prezista side effects in 38 year old female

Reported by a physician from Portugal on 2012-05-14

Patient: 38 year old female

Reactions: Dyspnoea, Stevens-Johnson Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prezista

Other drugs received by patient: Raltegravir; Ritonavir; Truvada



Possible Prezista side effects in female

Reported by a physician from Portugal on 2012-05-10

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Conjunctivitis, Rash, Pyrexia, Prothrombin Time Prolonged, Eosinophilia, Pruritus Generalised, Gamma-Glutamyltransferase Increased, Enanthema, Aspartate Aminotransferase Increased, Liver Function Test Abnormal, Hepatitis Toxic, Leukocytosis, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-22
    End date: 2012-03-15

Raltegravir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-22
    End date: 2012-03-15

Other drugs received by patient: Ritonavir; Tenofovir Disoproxil Fumarate; Emtricitabine; Tenofovir Disoproxil Fumarate



Possible Prezista side effects in 37 year old female

Reported by a health professional (non-physician/pharmacist) from Portugal on 2012-04-23

Patient: 37 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Prothrombin Level, Conjunctivitis, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Pyrexia, Rash, Eosinophilia, Pruritus Generalised, Enanthema, Gamma-Glutamyltransferase Increased, Liver Function Test Abnormal, Aspartate Aminotransferase Increased, Hepatitis Toxic, Leukocytosis, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-22
    End date: 2012-03-31

Prezista
    Indication: HIV Infection
    Start date: 2012-02-22
    End date: 2012-03-15

Other drugs received by patient: Norvir; Viread; Truvada



Possible Prezista side effects in female

Reported by a physician from Portugal on 2012-04-20

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Prothrombin Level, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Conjunctivitis, Rash, Pyrexia, Eosinophilia, Pruritus Generalised, Gamma-Glutamyltransferase Increased, Enanthema, Aspartate Aminotransferase Increased, Liver Function Test Abnormal, Hepatitis Toxic, Leukocytosis, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-22
    End date: 2012-03-15

Raltegravir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-22
    End date: 2012-03-15

Other drugs received by patient: Emtricitabine; Tenofovir Disoproxil Fumarate; Tenofovir Disoproxil Fumarate; Ritonavir



Possible Prezista side effects in 38 year old female

Reported by a physician from Portugal on 2012-03-29

Patient: 38 year old female

Reactions: Dyspnoea, Stevens-Johnson Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prezista

Other drugs received by patient: Raltegravir; Truvada; Ritonavir

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