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Index of reports
> Serious Reactions (77)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Intelence (Etravirine) serious reactions. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 77 Next >>
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
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 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 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 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 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 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
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 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 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 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 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
Possible Intelence side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-25
Patient: female, weighing 65.8 kg (144.7 pounds)
Reactions: Drug Dose Omission, Weight Increased, Abnormal Loss of Weight, Adverse Event, Stress
Drug(s) suspected as cause:
Intelence
Other drugs received by patient: Truvada
Possible Intelence side effects in 18 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21
Patient: 18 year old female
Reactions: Amniotic Fluid Volume Decreased
Drug(s) suspected as cause:
Epzicom
Administration route: Oral
Indication: Antiviral Treatment
Start date: 2011-11-15
End date: 2012-05-16
Intelence
Administration route: Oral
Indication: Antiviral Treatment
Start date: 2011-11-15
End date: 2012-05-16
Isentress
Administration route: Oral
Indication: Antiviral Treatment
Start date: 2011-11-15
End date: 2012-05-16
Norvir
Administration route: Oral
Indication: Antiviral Treatment
Start date: 2011-11-15
End date: 2012-05-16
Prezista
Administration route: Oral
Indication: Antiviral Treatment
Start date: 2011-11-15
End date: 2012-05-16
Retrovir
Indication: Antiviral Treatment
Start date: 2012-05-15
End date: 2012-05-16
Possible Intelence side effects in male
Reported by a health professional (non-physician/pharmacist) from Romania on 2012-06-20
Patient: male
Reactions: Hepatitis B
Drug(s) suspected as cause:
Intelence
Other drugs received by patient: Abacavir Sulfate / Lamivudine; Prezista
Possible Intelence side effects in 46 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-06-18
Patient: 46 year old male
Reactions: Joint Dislocation, Somnambulism, Lower Limb Fracture, Fall
Drug(s) suspected as cause:
Baraclude
Imovane
Intelence
Isentress
Administration route: Oral
Maraviroc
Prezista
Ritonavir
Other drugs received by patient: Oxycontin; Effexor XR; Gabapentin; Nortriptyline; Oxycodone
Possible Intelence side effects in male
Reported by a pharmacist from United States on 2012-06-14
Patient: male
Reactions: Rhabdomyolysis
Drug(s) suspected as cause:
Intelence
Administration route: Oral
Indication: HIV Infection
Prezista
Administration route: Oral
Indication: HIV Infection
Ritonavir
Indication: HIV Infection
Possible Intelence side effects in 65 year old male
Reported by a consumer/non-health professional from United States on 2012-06-12
Patient: 65 year old male, weighing 77.1 kg (169.6 pounds)
Reactions: Grip Strength Decreased, Gastrointestinal Disorder, Faecal Incontinence, Paraesthesia, Infrequent Bowel Movements
Drug(s) suspected as cause:
Intelence
Possible Intelence side effects in male
Reported by a health professional (non-physician/pharmacist) from Romania on 2012-06-12
Patient: male
Reactions: Hepatitis B
Drug(s) suspected as cause:
Intelence
Other drugs received by patient: Prezista; Abacavir Sulfate / Lamivudine
Possible Intelence side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-05
Patient: female, weighing 65.8 kg (144.7 pounds)
Reactions: Drug Dose Omission, Weight Increased, Adverse Event, Abnormal Loss of Weight, Stress
Drug(s) suspected as cause:
Intelence
Other drugs received by patient: Truvada
Possible Intelence side effects in female
Reported by a physician from Japan on 2012-06-01
Patient: female, weighing 49.0 kg (107.8 pounds)
Reactions: Back Pain, Oral Candidiasis, Insomnia, Rash, Gastric Ulcer, Liver Disorder
Drug(s) suspected as cause:
Intelence
Administration route: Oral
Indication: HIV Infection
Start date: 2011-06-13
Prednisolone
Dosage: at 13.31
Administration route: Oral
Start date: 2011-06-27
End date: 2011-07-08
Prednisolone
Administration route: Oral
Indication: Rash
Start date: 2011-08-01
End date: 2011-08-11
Prednisolone
Administration route: Oral
Start date: 2011-08-11
End date: 2011-08-22
Prednisolone
Dosage: at 8.43
Administration route: Oral
Start date: 2011-06-24
End date: 2011-06-27
Prednisolone
Administration route: Oral
Start date: 2011-07-16
End date: 2011-07-19
Prednisolone
Administration route: Oral
Start date: 2011-07-12
End date: 2011-07-16
Prednisolone
Administration route: Oral
Start date: 2011-07-19
End date: 2011-08-01
Prednisolone
Administration route: Oral
Start date: 2011-07-08
End date: 2011-07-12
Other drugs received by patient: Loxonin; Isentress; Myonal; Truvada; Truvada; Urso 250
Possible Intelence side effects in female
Reported by a physician from Japan on 2012-05-30
Patient: female, weighing 49.0 kg (107.8 pounds)
Reactions: Back Pain, Oral Candidiasis, Insomnia, Rash, Gastric Ulcer, Liver Disorder
Drug(s) suspected as cause:
Intelence
Administration route: Oral
Indication: HIV Infection
Start date: 2011-06-13
Prednisolone
Administration route: Oral
Indication: Rash
Start date: 2011-08-01
End date: 2011-08-11
Prednisolone
Administration route: Oral
Start date: 2011-08-11
End date: 2011-08-22
Prednisolone
Administration route: Oral
Start date: 2011-07-12
End date: 2011-07-16
Prednisolone
Administration route: Oral
Start date: 2011-07-16
End date: 2011-07-19
Prednisolone
Administration route: Oral
Start date: 2011-07-08
End date: 2011-07-12
Prednisolone
Administration route: Oral
Start date: 2011-07-19
End date: 2011-08-01
Prednisolone
Dosage: at 13.31
Administration route: Oral
Start date: 2011-06-27
End date: 2011-07-08
Prednisolone
Dosage: at 8.43
Administration route: Oral
Start date: 2011-06-24
End date: 2011-06-27
Other drugs received by patient: Truvada; Truvada; Myonal; Urso 250; Loxonin; Isentress
Possible Intelence side effects in male
Reported by a pharmacist from France on 2012-05-30
Patient: male, weighing 45.0 kg (99.0 pounds)
Reactions: Off Label Use, Pain in Extremity, Oedema Peripheral, Gait Disturbance
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Intelence
Other drugs received by patient: Osfolate; Unspecified Copd Medications; Ziagen; MS Contin; Isentress; Vitamin D; Ketoconazole; Eludril; Symbicort; Physiotens; Orocal D3; Toco; Locapred; Valacyclovir Hydrochloride; Bactrim
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