This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Intelence (Etravirine) 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 (128)
Death (21)
Life Threatening Events (6)
Disability (18)
Reports by Reaction Type
Abortion Spontaneous (17),
Maternal Exposure During Pregnancy (15),
Pyrexia (10),
Foetal Exposure During Pregnancy (8),
Exomphalos (8),
Rash (8),
Drug Interaction (7),
Renal Failure Acute (7),
Pollakiuria (7),
Neuropathy Peripheral (6),
Fanconi Syndrome (6),
Body Temperature Increased (5)
Below are a few examples of reports where side effects / adverse reactions may be related to Intelence (Etravirine). For a complete list or a specific selection of reports, please use the links above.
Possible Intelence 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 Intelence 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 Intelence 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 Intelence side effects in 52 year old male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 52 year old male, weighing 94.3 kg (207.5 pounds)
Reactions: Abdominal Pain, Blood Urine Present, Wrong Technique in Drug Usage Process, Hypersensitivity, LIP Disorder, Drug Ineffective, Urinary Tract Infection, Erectile Dysfunction, Somnolence, Neuropathy Peripheral, Prostatomegaly
Drug(s) suspected as cause:
Alcohol
Dosage: unk
Flomax
Dosage: 0.4 mg, daily
Indication: Prostatomegaly
Gabapentin
Dosage: unk
Indication: Neuropathy Peripheral
Start date: 2010-01-01
Intelence
Dosage: 100 mg, 4x/day
Indication: HIV Infection
Intelence
Dosage: 200 mg, 2x/day
Isentress
Dosage: 400 mg, 2x/day
Indication: HIV Infection
Norvir
Dosage: unk
Indication: HIV Infection
End date: 2007-01-01
Tramadol HCL
Dosage: 50 mg, unk
Indication: Migraine
Vicodin
Dosage: unk
Indication: Pain in Extremity
Vicodin
Indication: Back Pain
Other drugs received by patient: Ibuprofen
Possible Intelence 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 Intelence 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 Intelence 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 Intelence 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 Intelence side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13
Patient: male
Reactions: Fanconi Syndrome Acquired, Renal Failure Acute
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Intelence
Dosage: 400 mg, qd
Administration route: Oral
Indication: HIV Infection
Start date: 2011-05-27
End date: 2011-06-01
Isentress
Dosage: 800 mg, qd
Administration route: Oral
Indication: HIV Infection
Start date: 2011-05-27
End date: 2011-06-01
Norvir
Dosage: 1 df, qd
Administration route: Oral
Indication: HIV Infection
End date: 2011-06-01
Prezista
Dosage: 800 mg, qd
Administration route: Oral
Indication: HIV Infection
End date: 2011-06-01
Videx
Dosage: unk
Administration route: Oral
Indication: HIV Infection
End date: 2011-05-27
Viread
Dosage: unk
Administration route: Oral
Indication: HIV Infection
End date: 2011-05-27
Other drugs received by patient: Aspirin; Clomipramine HCL; Crestor; Mopral / 00661201 /; Suprane
Possible Intelence side effects in male
Reported by a physician from France on 2012-08-10
Patient: male, weighing 52.0 kg (114.4 pounds)
Reactions: Drug Eruption
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ganciclovir Sodium
Indication: Cytomegalovirus Infection
Start date: 2012-05-31
End date: 2012-06-09
Intelence
Administration route: Oral
Indication: HIV Infection
Start date: 2012-05-31
End date: 2012-06-11
Other drugs received by patient: Ethambutol Hydrochloride; Moxifloxacin HCL; Rimifon; Pyrazinamide
Possible Intelence side effects in male
Reported by a physician from France on 2012-08-10
Patient: male
Reactions: Weight Decreased, Confusional State, Hyperlactacidaemia, Hypothermia, Fanconi Syndrome, Tachycardia, Hypotension, Hepatic Failure, General Physical Health Deterioration, Dyspraxia, Livedo Reticularis, Pallor, Multi-Organ Failure, Hallucination, Visual, Tachypnoea, Cardiac Arrest, Renal Failure Acute
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Intelence
Dosage: form strength: 100mg
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: 2011-06-01
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: Aspirin; Crestor; Clomipramine HCL; Omeprazole; Drug NOS
Possible Intelence side effects in male
Reported by a physician from France on 2012-08-10
Patient: male
Reactions: Weight Decreased, Confusional State, Hyperlactacidaemia, Hypothermia, Fanconi Syndrome, Hypotension, Tachycardia, General Physical Health Deterioration, Hepatic Failure, Livedo Reticularis, Pallor, Incoherent, Multi-Organ Failure, Hallucination, Visual, Tachypnoea, Cardiac Arrest, Renal Failure Acute
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Intelence
Dosage: form strength: 100mg
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: 2011-06-01
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: Crestor; Omeprazole; Aspirin; Drug NOS; Clomipramine HCL
Possible Intelence side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-09
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: 2011-06-01
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: Crestor; Clomipramine HCL; Omeprazole; Unknown Medication; Aspirin
Possible Intelence side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-08-08
Patient: 40 year old female
Reactions: Premature Rupture of Membranes, Premature Baby, Maternal Exposure During Pregnancy, PRE-Eclampsia
Drug(s) suspected as cause:
Epivir
Dosage: 600mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-03-22
Intelence
Dosage: 400mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-04-19
End date: 2011-06-14
Kaletra
Dosage: 4tab per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-06-16
Norvir
Dosage: 100mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-04-04
End date: 2011-04-18
Retrovir
Dosage: 800mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-06-16
Reyataz
Dosage: 800mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-04-19
End date: 2011-06-16
Reyataz
Dosage: 300mgd per day
Administration route: Oral
Start date: 2011-04-04
End date: 2011-04-18
Possible Intelence side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: male, weighing 54.4 kg (119.7 pounds)
Reactions: Product Coating Issue, Burn Oesophageal, Retching, Choking, Product Solubility Abnormal
Drug(s) suspected as cause:
Intelence
Other drugs received by patient: Retrovir; Fuzeon; Prezista; Isentress
Possible Intelence side effects in 48 year old male
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: 48 year old male, weighing 74.8 kg (164.7 pounds)
Reactions: Retching, Pain, Product Solubility Abnormal, Foreign Body
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Intelence
Possible Intelence side effects in
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient:
Reactions: LOW Birth Weight Baby, Foetal Growth Restriction, Small FOR Dates Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Epzicom
Dosage: 1 df, qd
Start date: 2011-11-15
End date: 2012-05-16
Intelence
Dosage: 400 mg, qd
Start date: 2011-11-15
End date: 2012-05-16
Isentress
Dosage: 800 mg, qd
Indication: HIV Infection
Start date: 2011-11-15
End date: 2012-05-16
Norvir
Dosage: 200 mg, qd
Start date: 2011-11-15
End date: 2012-05-16
Prezista
Dosage: 1200 mg, qd
Start date: 2011-11-15
End date: 2012-05-16
Retrovir
Dosage: 2000 mg, qd
Start date: 2011-11-15
End date: 2012-05-16
Possible Intelence side effects in male
Reported by a pharmacist from France on 2012-07-25
Patient: male, weighing 45.0 kg (99.0 pounds)
Reactions: Off Label Use, Osteonecrosis, Pain in Extremity, Oedema Peripheral, Gait Disturbance
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Intelence
Other drugs received by patient: Toco; Eludril; MS Contin; Ziagen; Orocal D3; Locapred; Bactrim; Vitamin D; Osfolate; Valacyclovir Hydrochloride; Ketoconazole; Unspecified Copd Medications; Symbicort; Isentress; Physiotens
Possible Intelence side effects in
Reported by a pharmacist from Japan on 2012-07-20
Patient:
Reactions: Cerebral Infarction
Drug(s) suspected as cause:
Intelence
Possible Intelence side effects in 554 month old male
Reported by a physician from France on 2012-07-18
Patient: 554 month old male
Reactions: Blood Creatine Phosphokinase Increased, Neuropathy Peripheral
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Crestor
Administration route: Oral
Start date: 2011-11-01
Intelence
Administration route: Oral
Start date: 2008-11-01
Norvir
Administration route: Oral
Start date: 1999-01-01
Other drugs received by patient: Cialis; Maraviroc; Bactrim; Prezista; Isentress; Desloratadine
Possible Intelence side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-16
Patient: female, weighing 45.0 kg (99.0 pounds)
Reactions: Nightmare, Dystonia, Accidental Overdose
Drug(s) suspected as cause:
Intelence
Administration route: Oral
Start date: 2011-12-28
Intelence
Administration route: Oral
Start date: 2010-01-18
End date: 2010-12-01
Intelence
Administration route: Oral
Indication: HIV Infection
Start date: 2010-12-01
End date: 2011-10-01
Other drugs received by patient: Viread; Fluconazole; Levofloxacin; Reyataz; Bactrim; Ziagen; Fungizone; Isentress; Viread
Possible Intelence side effects in 49 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-16
Patient: 49 year old male
Reactions: Idiopathic Thrombocytopenic Purpura
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-01
End date: 2012-06-15
Intelence
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-01
End date: 2012-06-15
Other drugs received by patient: Acetaminophen
Possible Intelence side effects in male
Reported by a physician from United States on 2012-07-12
Patient: male, weighing 75.3 kg (165.7 pounds)
Reactions: Jaundice, Fatigue, Virologic Failure
Drug(s) suspected as cause:
Abacavir
Indication: HIV Infection
End date: 2012-04-15
Intelence
Indication: HIV Infection
Isentress
Indication: HIV Infection
Lamivudine
Indication: HIV Infection
Start date: 2012-04-15
Norvir
Norvir
Indication: HIV Infection
Norvir
Prezista
Administration route: Oral
Indication: HIV Infection
Reyataz
Indication: HIV Infection
Start date: 2012-04-15
End date: 2012-05-03
Reyataz
Indication: Multiple-Drug Resistance
Start date: 2012-04-15
End date: 2012-05-03
Possible Intelence side effects in
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-12
Patient:
Reactions: Neuropathy Peripheral
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Intelence
Dosage: 2 u, bid
Administration route: Oral
Indication: HIV Infection
Start date: 2009-06-01
Isentress
Dosage: 400 mg, bid
Administration route: Oral
Indication: Oesophagitis
Start date: 2009-06-01
Pantoprazole Sodium
Dosage: 40 mg, bid
Administration route: Oral
Indication: Oesophagitis
Other drugs received by patient: Ramipril; Allopurinol; Lamisil; Ezetimibe; Vitamin D; Bisoprolol Fumarate
Possible Intelence side effects in male
Reported by a pharmacist from France on 2012-07-10
Patient: male, weighing 45.0 kg (99.0 pounds)
Reactions: Off Label Use, Osteonecrosis, Pain in Extremity, Oedema Peripheral, Gait Disturbance
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Intelence
Other drugs received by patient: Toco; Locapred; Ketoconazole; Bactrim; Isentress; Valacyclovir Hydrochloride; Eludril; MS Contin; Symbicort; Orocal D3; Unspecified Copd Medications; Vitamin D; Ziagen; Physiotens; Osfolate
Possible Intelence side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-10
Patient: male, weighing 85.0 kg (187.0 pounds)
Reactions: Neuropathy Peripheral, Drug Interaction
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Intelence
Administration route: Oral
Indication: HIV Infection
Start date: 2009-06-01
Isentress
Administration route: Oral
Indication: HIV Infection
Start date: 2009-06-01
Other drugs received by patient possibly interacting with the suspect drug: Pantoprazole Sodium
Dosage: long time
Administration route: Oral
Indication: Oesophagitis
Other drugs received by patient: Ramipril; Allopurinol; Vitamin D; Bisoprolol Fumarate; Lamisil; Ezetimibe
Possible Intelence side effects in male
Reported by a physician from United States on 2012-07-09
Patient: male, weighing 75.3 kg (165.7 pounds)
Reactions: Jaundice, Virologic Failure, Fatigue
Drug(s) suspected as cause:
Abacavir
Indication: HIV Infection
End date: 2012-04-15
Intelence
Indication: HIV Infection
Isentress
Indication: HIV Infection
Lamivudine
Indication: HIV Infection
Start date: 2012-04-15
Norvir
Indication: HIV Infection
Norvir
Norvir
Prezista
Administration route: Oral
Indication: HIV Infection
Reyataz
Indication: HIV Infection
Start date: 2012-04-15
End date: 2012-05-03
Reyataz
Indication: Multiple-Drug Resistance
Start date: 2012-04-15
End date: 2012-05-03
Possible Intelence side effects in
Reported by a individual with unspecified qualification from United States on 2012-07-09
Patient:
Reactions: Product Dosage Form Confusion, Medication Error, Drug Name Confusion, Wrong Drug Administered, Intercepted Drug Dispensing Error, Drug Dispensing Error, Drug Prescribing Error
Drug(s) suspected as cause:
Intelence
Dosage: capsule oral 200 mg
Administration route: Oral
Sustiva
Dosage: capsule oral 200 mg
Administration route: Oral
Possible Intelence side effects in 49 year old male
Reported by a pharmacist from United Kingdom on 2012-07-06
Patient: 49 year old male
Reactions: Idiopathic Thrombocytopenic Purpura
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
Dosage: 1iuax per day
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-01
End date: 2012-06-15
Intelence
Dosage: 400mg per day
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-01
End date: 2012-06-15
Other drugs received by patient: Acetaminophen
Possible Intelence side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: male, weighing 54.4 kg (119.7 pounds)
Reactions: Retching, Choking, Product Solubility Abnormal
Drug(s) suspected as cause:
Intelence
Other drugs received by patient: Prezista; Fuzeon; Isentress; Retrovir
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