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Isentress (Raltegravir) - Thrombocytopenia - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Thrombocytopenia ()

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Isentress (Raltegravir) where reactions include thrombocytopenia. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Isentress 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:
Acetaminophen
    Dosage: df 10mg/ml
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Amikacin
    Dosage: 900 mg daily
    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
    End date: 2012-07-16

Cernevit-12
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Clarithromycin
    Dosage: df 50mg/ml
    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

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

Myambutol
    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

Olanzapine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Perikabiven (Parenteral Nutrition)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Potassium Chloride
    Administration route: Oral
    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

Rifabutin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

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

Other drugs received by patient: Propofol; Adavat



Possible Isentress 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:
Acetaminophen
    Dosage: df 10mg/ml
    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

Bactrim
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Cernevit-12
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-07-16

Clarithromycin
    Dosage: df 50mg/ml
    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

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

Myambutol
    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

Olanzapine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Perikabiven (Parenteral Nutrition)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Potassium Chloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Prazepam
    Administration route: Oral
    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

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

Other drugs received by patient: Adavat; Propofol



Possible Isentress side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13

Patient: male

Reactions: Confusional State, Agitation, Refusal of Treatment by Patient, Malnutrition, Anaemia, Coma, General Physical Health Deterioration, Pyrexia, Convulsion, Apathy, Hepatotoxicity, Diarrhoea, Thrombocytopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Acupan
    Dosage: 120 mg, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-16
    End date: 2012-07-27

Amikacin
    Dosage: 900 mg, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Bactrim
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-13

Cernevit / 01027001 /
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10
    End date: 2012-08-02

Clarithromycin
    Dosage: 500 mg, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Isentress
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-01

Kaletra
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01

Leucovorin Calcium
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Myambutol
    Dosage: 2 df, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Olanzapine
    Dosage: 1 df, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Perikabiven
    Dosage: unk
    Indication: Parenteral Nutrition
    Start date: 2012-07-10

Potassium Chloride
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Prazepam
    Dosage: 1 df, qd
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-10

Rifabutin
    Dosage: 150 mg, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-11

Truvada
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01



Possible Isentress side effects in 17 year old female

Reported by a physician from United States on 2012-07-02

Patient: 17 year old female, weighing 74.4 kg (163.7 pounds)

Reactions: Agitation, Tachycardia, Coagulopathy, Blood Albumin Decreased, Treatment Noncompliance, Herpes Zoster, Rash Pruritic, Metapneumovirus Infection, Nystagmus, Oedema Peripheral, Deafness Unilateral, Menorrhagia, Feeling of Despair, Metabolic Acidosis, Rhinovirus Infection, Pain in Extremity, Family Stress, Anaemia, Encephalopathy, Toxicity To Various Agents, Cardiomyopathy, Tremor, Aggression, Hepatic Steatosis, Fungal Infection, Dehydration, Rash Erythematous, Aspartate Aminotransferase Increased, Pancreatitis, Haemolytic Anaemia, Diabetic Ketoacidosis, Mobility Decreased, Electrocardiogram QT Prolonged, Atelectasis, Otitis Media Chronic, Suicidal Ideation, Hypokalaemia, Speech Disorder, Myalgia, Fungaemia, Arthritis Reactive, Pleural Effusion, Tachypnoea, Opportunistic Infection, Depression, Apparent Life Threatening Event, Electrolyte Imbalance, Thrombocytopenia, Lethargy, Self-Injurious Ideation, Blood Glucose Increased, Renal Failure Acute, Pneumonia Bordetella, Fluid Overload, Type 2 Diabetes Mellitus, Alanine Aminotransferase Increased, Musculoskeletal Pain, Hyponatraemia, Ear Infection, Diarrhoea, Arthralgia, Sepsis, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ceftazidime
    Dosage: /q8h/iv
    Indication: Pneumonia
    End date: 2010-05-12

Enalapril Maleate
    Dosage: /bid/po
    Administration route: Oral
    Indication: Cardiomyopathy
    End date: 2010-05-12

Isentress
    Dosage: 400 mg/bid/po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-02-08
    End date: 2009-01-14

Valtrex
    Dosage: /bid/po
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2010-05-12

Vancomycin
    Dosage: /q8h/iv
    Indication: Pyrexia
    End date: 2010-05-12

Other drugs received by patient: Pentamidine Isethionate



Possible Isentress side effects in 48 year old male

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-06-28

Patient: 48 year old male

Reactions: Body Temperature Increased, Thrombocytopenia, Transaminases Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Intelence
    Start date: 2012-03-07
    End date: 2012-03-09

Isentress
    Indication: HIV Infection
    Start date: 2012-03-07
    End date: 2012-03-09

Norvir
    Start date: 2012-03-07
    End date: 2012-03-09

Prezista
    Indication: HIV Infection
    Start date: 2012-03-07
    End date: 2012-03-09



Possible Isentress side effects in 41 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-04

Patient: 41 year old male

Reactions: Intussusception, Hepatic Function Abnormal, Coagulopathy, Anaemia, Toxicity To Various Agents, Death, Renal Failure, Thrombocytopenia, Pneumococcal Bacteraemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Isentress
    Administration route: Oral
    Indication: HIV Infection

Maraviroc
    Indication: HIV Infection

Other drugs received by patient: Lamivudine; Etravirine; Enfuvirtide



Possible Isentress side effects in 41 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30

Patient: 41 year old male

Reactions: Intussusception, Hepatic Function Abnormal, Coagulopathy, Anaemia, Toxicity To Various Agents, Death, Renal Failure, Pneumococcal Bacteraemia, Thrombocytopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Isentress
    Administration route: Oral
    Indication: HIV Infection

Maraviroc
    Indication: HIV Infection

Other drugs received by patient: Etravirine; Lamivudine; Enfuvirtide



Possible Isentress side effects in 45 year old male

Reported by a physician from United States on 2012-02-10

Patient: 45 year old male

Reactions: Renal Impairment, Anaemia, Thrombotic Thrombocytopenic Purpura, Thrombocytopenia, Sinusitis, Influenza Like Illness

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Acyclovir; Atripla



Possible Isentress side effects in 45 year old male

Reported by a physician from United States on 2012-01-20

Patient: 45 year old male

Reactions: Renal Impairment, Anaemia, Thrombotic Thrombocytopenic Purpura, Thrombocytopenia, Sinusitis, Influenza Like Illness

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Atripla; Acyclovir



Possible Isentress side effects in 17 year old female

Reported by a individual with unspecified qualification from United States on 2011-10-04

Patient: 17 year old female, weighing 69.9 kg (153.7 pounds)

Reactions: Agitation, Tachycardia, Deafness, Blood Albumin Decreased, Treatment Noncompliance, Herpes Zoster, Rash Pruritic, Face Oedema, Nystagmus, Metapneumovirus Infection, Cyanosis, Induration, Haemolytic Uraemic Syndrome, Respiratory Rate Increased, Metabolic Acidosis, Pneumonia, Rhinovirus Infection, Ear Disorder, Anaemia Haemolytic Autoimmune, Encephalopathy, Toxicity To Various Agents, Aggression, Hepatic Steatosis, Tremor, Dehydration, Ocular Hyperaemia, Rash Erythematous, Exfoliative Rash, Swelling, Pancreatitis, Diabetic Ketoacidosis, Rash Maculo-Papular, Atelectasis, Electrocardiogram QT Prolonged, Pain, Hypokalaemia, Suicidal Ideation, Myalgia, Fungaemia, Opportunistic Infection, Pleural Effusion, Tachypnoea, Toothache, Depression, Electrolyte Imbalance, Thrombocytopenia, Lethargy, Renal Failure Acute, Fluid Overload, Rash Generalised, Type 2 Diabetes Mellitus, Hyponatraemia, Ear Infection, Thrombotic Thrombocytopenic Purpura, Bronchiectasis, Diarrhoea, Arthralgia, Disease Recurrence, Alopecia, Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Pentamidine Isethionate

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