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Selzentry (Maraviroc) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Selzentry (Maraviroc) 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 (29)
Death (4)
Life Threatening Events (2)

Reports by Reaction Type

Cytolytic Hepatitis (4)Maternal Exposure During Pregnancy (4)Atrial Fibrillation (4)Acute Myocardial Infarction (3)Mitochondrial Myopathy Acquired (3)Arthralgia (3)Blood Creatine Phosphokinase Increased (2)Chest Pain (2)Meningitis (2)Nausea (2)Alanine Aminotransferase Increased (2)Coronary Artery Disease (2)

Possible Selzentry side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-14

Patient:

Reactions: Polydactyly, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress
    Indication: Antiviral Treatment
    Start date: 2012-01-01

Selzentry
    Indication: Antiviral Treatment
    Start date: 2012-01-01



Possible Selzentry side effects in 51 year old male

Reported by a physician from United States on 2012-07-19

Patient: 51 year old male, weighing 82.0 kg (180.4 pounds)

Reactions: Bacteraemia, Renal Failure Chronic, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vaccine (Non-Gsk)
    Start date: 2012-01-09

Selzentry
    Dosage: 150mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-25

Vaccine (Non-Gsk)
    Dosage: 4mgdl monthly
    Indication: Immunisation
    Start date: 2011-07-20

Abacavir
    Indication: HIV Infection
    Start date: 2012-04-29

Isentress
    Dosage: 400mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-25

Other drugs received by patient: Sustiva; Kaletra; Viread; Norvir; Multi-Vitamin; Androderm; Ibuprofen; Darunavir Ethanolate



Possible Selzentry side effects in 25 year old female

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

Patient: 25 year old female

Reactions: Cytolytic Hepatitis, Maternal Exposure During Pregnancy, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epzicom
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-05
    End date: 2012-03-19

Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-19

Selzentry
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-13
    End date: 2011-11-08

Kaletra
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-05
    End date: 2012-03-19

Norvir
    Dosage: 100mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-13
    End date: 2011-11-08

Raltegravir
    Dosage: 80mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-13
    End date: 2011-11-08

Prezista
    Dosage: 800mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-13
    End date: 2011-11-08

Truvada
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-13
    End date: 2011-11-08



Possible Selzentry side effects in 25 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2012-06-29

Patient: 25 year old female

Reactions: Maternal Exposure During Pregnancy, Cytolytic Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress
    Dosage: 80 mg/daily/po
    Administration route: Oral
    Start date: 2010-07-13
    End date: 2011-11-08

Combivir
    Dosage: 2 tab/daily/po
    Administration route: Oral
    Start date: 2012-03-19

Norvir
    Dosage: 100 mg/daily/po
    Administration route: Oral
    Start date: 2010-07-13
    End date: 2011-11-08

Kaletra
    Dosage: 2 tab/daily/po
    Administration route: Oral
    Start date: 2012-03-05
    End date: 2012-03-12

Truvada
    Dosage: 1 tab/daily/po
    Administration route: Oral
    Start date: 2010-07-13
    End date: 2011-11-08

Epzicom
    Dosage: 1 tab/daily/po
    Administration route: Oral
    Start date: 2012-03-05
    End date: 2012-03-12

Selzentry
    Dosage: 300 mg/daily/po
    Administration route: Oral
    Start date: 2010-07-13
    End date: 2011-11-08

Prezista
    Dosage: 800 mg/daily/po
    Administration route: Oral
    Start date: 2010-07-13
    End date: 2011-11-08



Possible Selzentry side effects in 25 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2012-06-25

Patient: 25 year old female

Reactions: Maternal Exposure During Pregnancy, Cytolytic Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Truvada
    Start date: 2010-07-13
    End date: 2011-11-08

Selzentry
    End date: 2011-11-08

Epzicom
    Start date: 2012-03-05
    End date: 2012-03-19

Kaletra
    Start date: 2012-03-05
    End date: 2012-03-19

Isentress
    Dosage: po
    Administration route: Oral
    End date: 2011-11-08

Norvir
    End date: 2011-11-08

Combivir

Prezista
    End date: 2011-11-08



Possible Selzentry side effects in 25 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-19

Patient: 25 year old female

Reactions: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Maternal Exposure During Pregnancy, Cytolytic Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Raltegravir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    End date: 2011-11-08

Combivir
    Indication: Antiretroviral Therapy
    Start date: 2012-03-19

Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-05
    End date: 2012-03-19

Selzentry
    Administration route: Oral
    Indication: Antiretroviral Therapy
    End date: 2011-11-08

Truvada
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-13
    End date: 2011-11-08

Norvir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    End date: 2011-11-08

Prezista
    Administration route: Oral
    Indication: Antiretroviral Therapy
    End date: 2011-11-08

Epzicom
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-05
    End date: 2012-03-19



Possible Selzentry side effects in male

Reported by a physician from United States on 2012-05-31

Patient: male

Reactions: Haemorrhage Intracranial, Lymphoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Selzentry

Other drugs received by patient: Unknown



Possible Selzentry side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-29

Patient: 65 year old male, weighing 80.9 kg (178.0 pounds)

Reactions: Chest Pain, Plaque Shift, Coronary Artery Disease, Coronary Arterial Stent Insertion

Adverse event resulted in: life threatening event, hospitalization

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

Protease Inhibitor



Possible Selzentry side effects in 47 year old male

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: 47 year old male

Reactions: Blood Creatine Phosphokinase Increased, Mitochondrial Myopathy Acquired, Muscular Weakness, Hemiparesis, Exercise Tolerance Decreased, Myopathy, Mitochondrial Cytopathy, Gait Disturbance, Asthenia

Drug(s) suspected as cause:
Epzicom
    Indication: HIV Infection

Reyataz
    Indication: HIV Infection

Selzentry
    Indication: HIV Infection

Testim
    Dosage: 50mg per day
    Indication: Blood Testosterone Decreased
    Start date: 2010-12-01
    End date: 2012-01-01

Intelence
    Indication: HIV Infection

Truvada
    Indication: HIV Infection



Possible Selzentry side effects in 47 year old male

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: 47 year old male, weighing 86.0 kg (189.2 pounds)

Reactions: Mitochondrial Myopathy Acquired

Drug(s) suspected as cause:
Reyataz
    Indication: HIV Infection

Truvada
    Indication: HIV Infection

Intelence
    Indication: HIV Infection

Epzicom
    Indication: HIV Infection

Selzentry
    Indication: HIV Infection

Testim
    Dosage: gel
    Indication: Blood Testosterone Decreased
    Start date: 2010-12-01
    End date: 2012-01-01

Testim
    Dosage: gel
    Indication: Myopathy
    Start date: 2010-12-01
    End date: 2012-01-01



Possible Selzentry side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-14

Patient: male, weighing 190.0 kg (418.0 pounds)

Reactions: Blood Creatine Phosphokinase Increased, Mitochondrial Myopathy Acquired

Drug(s) suspected as cause:
Testim
    Indication: Myopathy
    Start date: 2010-12-01
    End date: 2012-01-01

Epzicom
    Indication: HIV Infection

Reyataz
    Indication: HIV Infection

Intelence
    Administration route: Oral
    Indication: HIV Infection

Testim
    Indication: Blood Testosterone Decreased
    Start date: 2010-12-01
    End date: 2012-01-01

Truvada
    Indication: HIV Infection

Selzentry
    Indication: HIV Infection



Possible Selzentry side effects in 44 year old male

Reported by a consumer/non-health professional from United States on 2012-04-23

Patient: 44 year old male, weighing 74.1 kg (163.0 pounds)

Reactions: Abdominal Pain, Weight Decreased, Vomiting, Lymphadenopathy, Nausea, Drug Intolerance, Local Swelling, Pyrexia, Anxiety, Fatigue, Diarrhoea, Chest Pain, Skin Lesion, Vision Blurred, Tenderness, Meningitis

Adverse event resulted in: death

Drug(s) suspected as cause:
Selzentry
    Dosage: 300mg twice per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Epzicom
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Bactrim; Ensure; Nystatin



Possible Selzentry side effects in 52 year old male

Reported by a physician from United States on 2012-02-24

Patient: 52 year old male, weighing 57.7 kg (126.9 pounds)

Reactions: Pancreatic Carcinoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Selzentry
    Dosage: 600mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-19
    End date: 2010-09-18

Truvada
    Dosage: 1tab per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-19
    End date: 2010-09-18

Intelence
    Dosage: 400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-19
    End date: 2010-09-18

Isentress
    Dosage: 800mg per day
    Indication: HIV Infection
    Start date: 2009-02-19
    End date: 2010-09-18

Other drugs received by patient: Trazodone HCL; Albuterol Inhaler; Starlix; Bactrim DS; Xanax; Vicodin ES; Prevacid; Lantus; Bentyl; Lexapro; Vitamin B-12; Singulair



Possible Selzentry side effects in 44 year old male

Reported by a physician from United States on 2012-02-15

Patient: 44 year old male, weighing 74.1 kg (163.0 pounds)

Reactions: Acute Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selzentry

Other drugs received by patient: Atorvastatin; Aspirin; Epzicom



Possible Selzentry side effects in 69 year old male

Reported by a physician from United States on 2012-02-15

Patient: 69 year old male, weighing 110.9 kg (244.0 pounds)

Reactions: Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selzentry
    Dosage: 600mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-06-06

Truvada
    Dosage: 1tab per day
    Indication: HIV Infection
    Start date: 2011-06-06

Other drugs received by patient: Metformin HCL; Lipitor; Aspirin; Spironolactone; Advair Diskus 100 / 50; Combivent



Possible Selzentry side effects in 44 year old male

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

Patient: 44 year old male, weighing 74.1 kg (163.0 pounds)

Reactions: Acute Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selzentry

Other drugs received by patient: Atorvastatin; Epzicom; Aspirin



Possible Selzentry side effects in 45 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-13

Patient: 45 year old male

Reactions: Weight Increased, Cardiac Failure Congestive

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Selzentry

Other drugs received by patient: Etravirine; Bactrim; Raltegravir



Possible Selzentry side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2012-01-06

Patient: 50 year old male

Reactions: Flushing, Agitation, Feeling Hot, Atrial Fibrillation

Drug(s) suspected as cause:
Selzentry

Other drugs received by patient: Dapsone; Acidophilus; Alprazolam; Proscar; Flomax; Multi-Vitamin; Lexiva; Cymbalta; Truvada



Possible Selzentry side effects in 69 year old male

Reported by a physician from United States on 2011-12-22

Patient: 69 year old male, weighing 110.9 kg (244.0 pounds)

Reactions: Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selzentry
    Dosage: 600mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-06-06

Truvada
    Dosage: 1tab per day
    Indication: HIV Infection
    Start date: 2011-06-06

Other drugs received by patient: Metformin HCL; Advair Diskus 100 / 50; Spironolactone; Aspirin; Lipitor; Combivent



Possible Selzentry side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-15

Patient: male

Reactions: Meningitis

Adverse event resulted in: death

Drug(s) suspected as cause:
Epzicom
    Indication: Product Used FOR Unknown Indication

Selzentry
    Dosage: 300mg unknown
    Indication: Product Used FOR Unknown Indication



Possible Selzentry side effects in 52 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-15

Patient: 52 year old male

Reactions: Ileus Paralytic

Drug(s) suspected as cause:
Selzentry



Possible Selzentry side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2011-10-24

Patient: 65 year old male, weighing 79.4 kg (174.6 pounds)

Reactions: Initial Insomnia, Pain in Extremity, Arthralgia, Discomfort

Drug(s) suspected as cause:
Selzentry

Other drugs received by patient: Truvada; Acyclovir; Isentress; Gemfibrozil



Possible Selzentry side effects in 44 year old male

Reported by a physician from United States on 2011-10-20

Patient: 44 year old male, weighing 74.1 kg (163.0 pounds)

Reactions: Coronary Artery Disease, Acute Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selzentry

Other drugs received by patient: Aspirin; Epzicom; Atorvastatin



Possible Selzentry side effects in 69 year old male

Reported by a physician from United States on 2011-10-17

Patient: 69 year old male, weighing 110.9 kg (244.0 pounds)

Reactions: Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selzentry
    Dosage: 600mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-06-06

Truvada
    Dosage: 1tab per day
    Indication: HIV Infection
    Start date: 2011-06-06

Other drugs received by patient: Metformin Hydrochloride; Aspirin; Lipitor; Combivent; Spironolactone; Advair Diskus 100 / 50



Possible Selzentry side effects in 47 year old female

Reported by a physician from United States on 2011-10-04

Patient: 47 year old female

Reactions: CD4 Lymphocytes Decreased

Drug(s) suspected as cause:
Selzentry
    Dosage: 300mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-01-28

Truvada
    Indication: HIV Infection
    Start date: 2011-01-28



Possible Selzentry side effects in male

Reported by a physician from United States on 2011-10-04

Patient: male

Reactions: Tooth Discolouration

Drug(s) suspected as cause:
Selzentry



Possible Selzentry side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 64 year old male

Reactions: Arthralgia

Drug(s) suspected as cause:
Selzentry

Other drugs received by patient: Truvada; Lopid; Acyclovir; Isentress; Vicodin



Possible Selzentry side effects in 59 year old male

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 59 year old male

Reactions: Blood Chloride Decreased, Myalgia, Blood Calcium Decreased, Blood Potassium Decreased, Arthralgia, Carbon Dioxide Decreased, Electrolyte Imbalance, Blood Glucose Increased, Influenza Like Illness

Drug(s) suspected as cause:
Selzentry

Other drugs received by patient: Isentress; Androgel; Diazepam



Possible Selzentry side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-04

Patient: male

Reactions: Nausea, Incorrect Dose Administered, Abdominal Distension

Drug(s) suspected as cause:
Selzentry

Other drugs received by patient: Intelence; Lexiva

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