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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