This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Edurant (Rilpivirine) 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 (16)
Death (4)
Life Threatening Events (7)
Reports by Reaction Type
Pyrexia (6),
Rash Generalised (6),
Abortion Spontaneous (4),
Cystic Lymphangioma (4),
Renal Failure Acute (4),
Loss of Consciousness (3),
Blood Creatinine Increased (3),
Nausea (3),
Blood Triglycerides Increased (1),
CD4 Lymphocytes Decreased (1),
Glomerular Filtration Rate Decreased (1),
Intensive Care (1)
Possible Edurant 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:
Truvada
Indication: Maternal Exposure Timing Unspecified
Prezista
Indication: Maternal Exposure Timing Unspecified
Edurant
Indication: Maternal Exposure Timing Unspecified
Norvir
Indication: Maternal Exposure Timing Unspecified
Possible Edurant side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27
Patient:
Reactions: Cystic Lymphangioma, Abortion Spontaneous
Adverse event resulted in: death
Drug(s) suspected as cause:
Norvir
Indication: Maternal Exposure Timing Unspecified
Edurant
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Prezista
Indication: Maternal Exposure Timing Unspecified
Possible Edurant side effects in male
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-07-12
Patient: male
Reactions: Intensive Care
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Edurant
Possible Edurant side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02
Patient: male, weighing 64.9 kg (142.7 pounds)
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epzicom
Administration route: Oral
Indication: HIV Infection
Start date: 2012-04-23
End date: 2012-04-28
Lisinopril
Administration route: Oral
Indication: Hypertension
Start date: 2012-03-19
End date: 2012-05-29
Edurant
Administration route: Oral
Indication: HIV Infection
Start date: 2012-04-23
End date: 2012-04-28
Possible Edurant side effects in 43 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-12
Patient: 43 year old male, weighing 65.9 kg (145.0 pounds)
Reactions: CD4 Lymphocytes Decreased, Glomerular Filtration Rate Decreased, Nausea, Blood Lactate Dehydrogenase Increased, Blood Triglycerides Increased, Loss of Consciousness, Blood Creatinine Increased, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Edurant
Dosage: 25mg per day
Indication: Product Used FOR Unknown Indication
Start date: 2012-04-23
End date: 2012-04-28
Epzicom
Dosage: 1tab per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-04-23
End date: 2012-04-28
Other drugs received by patient: Lisinopril
Possible Edurant side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-30
Patient: male
Reactions: Rash Generalised, Pyrexia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Intelence
Administration route: Oral
Indication: HIV Infection
Edurant
Administration route: Oral
Indication: HIV Infection
Possible Edurant side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-24
Patient: male
Reactions: Rash Generalised, Pyrexia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Edurant
Possible Edurant side effects in 43 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24
Patient: 43 year old male
Reactions: Nausea, Blood Creatinine Increased, Renal Failure Acute, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Edurant
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Epzicom
Indication: Product Used FOR Unknown Indication
Possible Edurant side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: male
Reactions: Rash Generalised, Pyrexia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Edurant
Administration route: Oral
Indication: HIV Infection
Intelence
Administration route: Oral
Indication: HIV Infection
Prezista
Indication: HIV Infection
Possible Edurant side effects in 43 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-11
Patient: 43 year old male
Reactions: Nausea, Blood Creatinine Increased, Renal Failure Acute, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Edurant
Dosage: 25mg per day
Indication: Product Used FOR Unknown Indication
Epzicom
Dosage: 1tab per day
Indication: Product Used FOR Unknown Indication
Possible Edurant side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-18
Patient: male
Reactions: Rash Generalised, Pyrexia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Edurant
Indication: HIV Infection
Prezista
Indication: HIV Infection
Possible Edurant side effects in male
Reported by a physician from United States on 2012-04-18
Patient: male
Reactions: Rash Generalised, Pyrexia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Edurant
Possible Edurant side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-18
Patient: male
Reactions: Rash Generalised, Pyrexia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Intelence
Administration route: Oral
Indication: HIV Infection
Edurant
Administration route: Oral
Indication: HIV Infection
Possible Edurant side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-01
Patient:
Reactions: Cystic Lymphangioma, Abortion Spontaneous
Adverse event resulted in: death
Drug(s) suspected as cause:
Truvada
Indication: Maternal Exposure Timing Unspecified
Norvir
Indication: Maternal Exposure Timing Unspecified
Edurant
Indication: Maternal Exposure Timing Unspecified
Prezista
Indication: Maternal Exposure Timing Unspecified
Possible Edurant side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-27
Patient:
Reactions: Cystic Lymphangioma, Abortion Spontaneous
Adverse event resulted in: death
Drug(s) suspected as cause:
Prezista
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Edurant
Indication: Maternal Exposure Timing Unspecified
Norvir
Indication: Maternal Exposure Timing Unspecified
Possible Edurant side effects in male
Reported by a physician from United States on 2011-11-07
Patient: male, weighing 85.3 kg (187.6 pounds)
Reactions: Pancreatitis, Lipase Increased
Drug(s) suspected as cause:
Edurant
Other drugs received by patient: Mirtazapine; Truvada; Norco; Tramadol HCL; Bactrim; Ferrous Sulfate TAB; Fluconazole
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