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Index of reports
> Cases with Immune Reconstitution Syndrome (18)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Truvada where reactions include immune reconstitution syndrome. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Truvada 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:
Prezista
Administration route: Oral
Indication: HIV Infection
Start date: 2012-01-13
End date: 2012-08-02
Norvir
Administration route: Oral
Indication: HIV Infection
Start date: 2012-01-13
End date: 2012-08-02
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
Truvada
Administration route: Oral
Indication: HIV Infection
Start date: 2012-01-13
End date: 2012-08-02
Possible Truvada side effects in male
Reported by a physician from France on 2012-08-16
Patient: male
Reactions: Agitation, Urinary Incontinence, Coma, Coma Scale Abnormal, Pyrexia, Hepatotoxicity, Eye Movement Disorder, Hepatosplenomegaly, Anaemia, Malnutrition, General Physical Health Deterioration, Encephalopathy, Faecal Incontinence, Convulsion, Respiratory Tract Congestion, Apathy, Depressed Level of Consciousness, Nervous System Disorder, Confusional State, Immune Reconstitution Syndrome, Snoring, Hepatitis Cholestatic, Intracranial Pressure Increased, Hepatic Ischaemia, Thrombocytopenia, Oxygen Saturation Decreased, Refusal of Treatment by Patient, Necrotising Granulomatous Lymphadenitis, Hepatic Fibrosis, Mycobacterial Infection, Hyponatraemia, Cerebral Atrophy, White Blood Cell Disorder, Renal Failure, Hypoproteinaemia, Diarrhoea, Brain Abscess, Heart Rate Increased, Encephalitic Infection, Heart Sounds Abnormal
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Bactrim
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Olanzapine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-01
Clarithromycin
Dosage: df 50mg/ml
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Nefopam
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Prazepam
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Truvada
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-01
Viramune
Indication: HIV Infection
Start date: 2012-03-01
End date: 2012-05-01
Myambutol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Amikacin
Dosage: 900 mg daily
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Cernevit-12
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Rifabutin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Folic Acid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Kaletra
Dosage: df 80/20 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-01
Perikabiven (Parenteral Nutrition)
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Isentress
Administration route: Oral
Indication: HIV Infection
Start date: 2012-05-01
Potassium Chloride
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Acetaminophen
Dosage: df 10mg/ml
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Other drugs received by patient: Propofol; Adavat
Possible Truvada side effects in male
Reported by a physician from France on 2012-08-15
Patient: male
Reactions: Agitation, Urinary Incontinence, Coma, Pyrexia, Coma Scale Abnormal, Hepatotoxicity, Eye Movement Disorder, Hepatosplenomegaly, Anaemia, Malnutrition, Encephalopathy, Faecal Incontinence, General Physical Health Deterioration, Convulsion, Apathy, Respiratory Tract Congestion, Depressed Level of Consciousness, Nervous System Disorder, Confusional State, Immune Reconstitution Syndrome, Snoring, Hepatitis Cholestatic, Intracranial Pressure Increased, Hepatic Ischaemia, Thrombocytopenia, Oxygen Saturation Decreased, Refusal of Treatment by Patient, Necrotising Granulomatous Lymphadenitis, Hepatic Fibrosis, Mycobacterial Infection, Cerebral Atrophy, Hyponatraemia, Renal Failure, White Blood Cell Disorder, Diarrhoea, Hypoproteinaemia, Heart Rate Increased, Brain Abscess, Encephalitic Infection, Heart Sounds Abnormal
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Olanzapine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-01
Clarithromycin
Dosage: df 50mg/ml
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Bactrim
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
Amikacin
Dosage: 900 mg daily
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Acetaminophen
Dosage: df 10mg/ml
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
Perikabiven (Parenteral Nutrition)
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
Rifabutin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Cernevit-12
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Nefopam
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
End date: 2012-07-16
Viramune
Indication: HIV Infection
Start date: 2012-03-01
End date: 2012-05-01
Myambutol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-11
Potassium Chloride
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
Folic Acid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
Isentress
Administration route: Oral
Indication: HIV Infection
Start date: 2012-05-01
Kaletra
Dosage: df 80/20 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-01
Prazepam
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-10
Truvada
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-01
Other drugs received by patient: Adavat; Propofol
Possible Truvada side effects in
Reported by a physician from Japan on 2012-08-01
Patient:
Reactions: Pneumocystis Jiroveci Pneumonia, Immune Reconstitution Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Isentress
Dosage: divided dose frequency unknown
Administration route: Oral
Indication: HIV Infection
Start date: 2010-06-08
Isentress
Dosage: divided dose frequency u
Administration route: Oral
Start date: 2010-06-08
Truvada
Dosage: divided dose frequency u
Administration route: Oral
Indication: HIV Infection
Start date: 2010-06-08
Other drugs received by patient: Pepcid RPD; Famotidine
Possible Truvada side effects in 29 year old male
Reported by a physician from Japan on 2012-08-01
Patient: 29 year old male
Reactions: Hydronephrosis, Immune Reconstitution Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Isentress
Dosage: unk
Administration route: Oral
Indication: HIV Infection
Truvada
Dosage: unk
Administration route: Oral
Indication: HIV Infection
Other drugs received by patient: Doxil
Possible Truvada side effects in 29 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-24
Patient: 29 year old male
Reactions: Immune Reconstitution Syndrome, Hydronephrosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Truvada
Dosage: unk
Administration route: Oral
Indication: HIV Infection
Isentress
Dosage: unk
Administration route: Oral
Indication: HIV Infection
Other drugs received by patient: Doxil
Possible Truvada side effects in 15 year old female
Reported by a individual with unspecified qualification from United States on 2012-07-02
Patient: 15 year old female
Reactions: Immune Reconstitution Syndrome
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Truvada
Other drugs received by patient: Raltegravir; Nevirapine
Possible Truvada side effects in 37 year old male
Reported by a individual with unspecified qualification from Japan on 2012-06-29
Patient: 37 year old male
Reactions: Pneumocystis Jiroveci Pneumonia, Immune Reconstitution Syndrome, Blood Lactate Dehydrogenase Increased, Condition Aggravated
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Isentress
Dosage: 800 mg/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2010-06-08
Truvada
Dosage: 1 dose/daily po
Administration route: Oral
Indication: HIV Infection
Start date: 2010-06-08
Other drugs received by patient: Pepcid RPD
Possible Truvada side effects in 48 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-27
Patient: 48 year old female, weighing 54.0 kg (118.8 pounds)
Reactions: Immune Reconstitution Syndrome, Drug Abuse, Upper Respiratory Tract Infection, Intervertebral Disc Disorder, White Blood Cell Count Decreased, Back Pain, Urinary Tract Infection, Faecal Incontinence, Muscular Weakness, Hypoaesthesia, Paraesthesia, Haemoglobin Decreased, Osteoarthritis, HIP Fracture, Femoral Neck Fracture, Stress Fracture, Spinal Osteoarthritis, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Isentress
Dosage: 400 mg/bid/po
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-15
Truvada
Dosage: 500 mg/daily/po
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-15
Other drugs received by patient: Trazodone Hydrochloride; Cocaine
Possible Truvada side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from Nigeria on 2012-05-30
Patient: 40 year old female
Reactions: Immune Reconstitution Syndrome, Dermatomyositis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nevirapine
Dosage: 400 mg
Indication: HIV Infection
Truvada
Dosage: strength: tablet of tenofovir 300 mg + emtricitabine 300 mg
Administration route: Oral
Indication: HIV Infection
Other drugs received by patient: Acetaminophen; Piroxicam
Possible Truvada side effects in 48 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-29
Patient: 48 year old female, weighing 54.0 kg (118.8 pounds)
Reactions: Productive Cough, Lymphadenopathy, Immune Reconstitution Syndrome, Drug Abuse, Haematocrit Decreased, RED Blood Cell Count Decreased, Upper Respiratory Tract Infection, Vena Cava Thrombosis, Intervertebral Disc Degeneration, Urinary Tract Infection, Axillary Vein Thrombosis, Faecal Incontinence, Muscular Weakness, Hypoaesthesia, Subclavian Vein Thrombosis, Paraesthesia, Haemoglobin Decreased, HIP Fracture, Arthralgia, Neoplasm Malignant, Stress Fracture, Femoral Neck Fracture, Sputum Discoloured, Deep Vein Thrombosis, Staphylococcus Test Positive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Isentress
Dosage: 400 mg/bid/po
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-15
Truvada
Dosage: 500 mg/daily/po
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-15
Other drugs received by patient: Trazodone HCL; Cocaine
Possible Truvada side effects in 48 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-16
Patient: 48 year old female, weighing 54.0 kg (118.8 pounds)
Reactions: Back Pain, Immune Reconstitution Syndrome, Lymphadenopathy, Faecal Incontinence, Hypoaesthesia, Paraesthesia, HIP Fracture, Thrombophlebitis Superficial, Vena Cava Thrombosis, Stress Fracture, Deep Vein Thrombosis, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Isentress
Dosage: 400 mg, bid, po
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-15
Truvada
Dosage: 500 mg, daily, po
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-15
Other drugs received by patient: Trazodone HCL; Cocaine
Possible Truvada side effects in
Reported by a physician from Japan on 2012-05-09
Patient:
Reactions: Immune Reconstitution Syndrome, Parotid Lipomatosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ritonavir
Indication: HIV Infection
Truvada
Indication: HIV Infection
Darunavir Hydrate
Indication: HIV Infection
Other drugs received by patient: Valganciclovir; Foscarnet; CAM; Rifampicin; Ciprofloxacin; Ethambutol Hydrochloride
Possible Truvada side effects in 45 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-03-16
Patient: 45 year old male
Reactions: Pneumonia, Immune Reconstitution Syndrome, Lymphadenopathy, Respiratory Failure, Hypotension, Anaemia, Pancytopenia, Kaposi's Sarcoma, Pyrexia, Hepatosplenomegaly
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Methylprednisolone
Dosage: 1 mg/kg/day
Indication: Pneumonia
Start date: 2010-02-01
Nevirapine
Indication: HIV Infection CDC Category A2
Start date: 2009-11-01
Truvada
Indication: HIV Infection CDC Category A2
Start date: 2009-11-01
Possible Truvada side effects in 45 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-03-09
Patient: 45 year old male
Reactions: Pneumonia, Immune Reconstitution Syndrome, Lymphadenopathy, Hypotension, Anaemia, Kaposi's Sarcoma, Pancytopenia, Pyrexia, Respiratory Failure, Hepatosplenomegaly
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nevirapine
Indication: HIV Infection CDC Category A2
Start date: 2009-11-01
Truvada
Indication: HIV Infection CDC Category A2
Start date: 2009-11-01
Methylprednisolone
Dosage: 1 mg/kg/day
Indication: Pneumonia
Start date: 2010-02-01
Possible Truvada side effects in 19 year old female
Reported by a health professional (non-physician/pharmacist) from Nigeria on 2012-03-02
Patient: 19 year old female
Reactions: Immune Reconstitution Syndrome
Adverse event resulted in: death
Drug(s) suspected as cause:
Truvada
Indication: HIV Infection
Efavirenz
Indication: HIV Infection
Possible Truvada side effects in male
Reported by a physician from Japan on 2011-11-22
Patient: male
Reactions: Immune Reconstitution Syndrome, Disseminated Tuberculosis, Lung Infection
Drug(s) suspected as cause:
Epzicom
Dosage: 1iuax per day
Administration route: Oral
Indication: Acquired Immunodeficiency Syndrome
Start date: 2010-10-05
Kaletra
Dosage: 4iuax per day
Administration route: Oral
Indication: Acquired Immunodeficiency Syndrome
Start date: 2009-07-14
End date: 2010-10-04
Norvir
Dosage: 100mg per day
Administration route: Oral
Indication: Acquired Immunodeficiency Syndrome
Start date: 2011-02-17
End date: 2011-03-30
Truvada
Dosage: 1iuax per day
Administration route: Oral
Indication: Acquired Immunodeficiency Syndrome
Start date: 2009-07-14
End date: 2010-10-04
Prezista
Dosage: 800mg per day
Administration route: Oral
Indication: Acquired Immunodeficiency Syndrome
Start date: 2011-02-28
End date: 2011-03-30
Isentress
Dosage: 800mg per day
Administration route: Oral
Indication: Acquired Immunodeficiency Syndrome
Start date: 2010-10-05
End date: 2010-10-22
Kaletra
Dosage: 4iuax per day
Administration route: Oral
Start date: 2011-02-17
End date: 2011-02-27
Isentress
Dosage: 800mg per day
Administration route: Oral
Start date: 2011-03-31
Lexiva
Dosage: 2800mg per day
Administration route: Oral
Indication: Acquired Immunodeficiency Syndrome
Start date: 2010-10-23
End date: 2011-02-16
Other drugs received by patient: Sulfamethoxazole and Trimethoprim
Possible Truvada side effects in 41 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2011-10-11
Patient: 41 year old female
Reactions: Immune Reconstitution Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Norvir
Administration route: Oral
Indication: HIV Infection
Start date: 2010-11-03
End date: 2010-12-01
Reyataz
Administration route: Oral
Indication: HIV Infection
Start date: 2010-11-03
End date: 2010-12-01
Truvada
Administration route: Oral
Indication: HIV Infection
Start date: 2010-11-03
End date: 2010-12-01
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