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Crixivan (Indinavir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Crixivan (Indinavir) 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 (10)
Death (3)
Life Threatening Events (3)
Disability (3)

Reports by Reaction Type

Pulmonary Hypertension (3)Palpitations (3)Dizziness (3)Death (2)T-Lymphocyte Count Decreased (2)Dementia (1)Pain (1)Drug Interaction (1)Hemiparesis (1)Pupils Unequal (1)Pyrexia (1)Progressive External Ophthalmoplegia (1)

Possible Crixivan side effects in 24 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 24 year old male

Reactions: Pulmonary Hypertension, Palpitations, Dizziness

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Crixivan
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-03-18
    End date: 2000-05-24

Efavirenz
    Dosage: interrupted from 07/25/00 to 09/25/00 24jul-25jul2000,25sep-02oct2000. film coated tab 200 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2000-10-02

Epivir
    Dosage: tabs
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-05-15
    End date: 2008-09-19

Invirase
    Dosage: inter:03/18/00-05/24/00,caps 800mg:19jun99-18mar2000.divided dse:24may00-24dec2000,19jun1999-24dc00
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 2001-03-31

Kaletra
    Dosage: 1df,25dec2000-24apr2004:1217 days
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-12-25
    End date: 2004-04-24

Norvir
    Dosage: 31mar2001(interrupted).caps 800mg:19jun99-31oct-99.divided dose:01nov99-24dec2000.25apr2004
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 2008-09-19

Videx
    Dosage: 250,300,400mg12/19/94-3/7/97,3/07/97-7/21/01,7/21/01,125mg,19dc94-7mar97(810d),7mr97-21jl01(1598d)
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1994-12-19
    End date: 2001-07-21

Videx EC
    Dosage: divided dose
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2001-07-21
    End date: 2004-05-14

Zerit
    Dosage: 60 mg 8/25/97-27/2/98, 80 mg 2/27-8/3/98, 11/9/98 -6/19/99 and 12/25/00-10/20/01
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1997-08-25
    End date: 2001-10-20

Ziagen
    Dosage: interrupted from 07/25/00 to 10/20/01 tabs24jul-25jul2000.20oct2001-27oct2001.
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2001-10-27

Other drugs received by patient: Cross Eight M



Possible Crixivan side effects in

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

Patient:

Reactions: Therapeutic Response Decreased, Drug Interaction

Drug(s) suspected as cause:
Crixivan

Other drugs received by patient possibly interacting with the suspect drug:
Venlafaxine Hydrocholride
    Dosage: 150 mg, qd
    Indication: Major Depression

Other drugs received by patient: Lamivudine + Zidovudine



Possible Crixivan side effects in

Reported by a individual with unspecified qualification on 2012-07-11

Patient: , weighing 2.3 kg (5.1 pounds)

Reactions: Cleft LIP, Maternal Drugs Affecting Foetus, Polydactyly

Drug(s) suspected as cause:
Crixivan
    Dosage: 800 mg/day, transplacental
    Indication: Antiviral Treatment
    Start date: 2006-02-24
    End date: 2011-08-10

Kaletra
    Dosage: 4 tab/caps, transplacental
    Indication: Antiviral Treatment
    Start date: 2011-08-10

Kaletra
    Dosage: 4 tab/caps, transplacental
    Indication: Antiviral Treatment
    Start date: 2011-08-10

Lamivudine
    Dosage: 300 mg/day, transplacental
    Indication: Antiviral Treatment
    Start date: 2002-10-25

Norvir
    Dosage: 200 mg/day, transplacental
    Indication: Antiviral Treatment
    Start date: 2006-02-24
    End date: 2011-08-10

Videx
    Dosage: 250 mg/day, transplacental
    Indication: Antiviral Treatment
    Start date: 2006-02-24
    End date: 2011-08-10

Zidovudine
    Dosage: 400 mg/day, transplacental
    Indication: Antiviral Treatment
    Start date: 2011-08-10

Other drugs received by patient: Folate (Folic Acid)



Possible Crixivan side effects in 31 year old male

Reported by a physician from United States on 2012-06-20

Patient: 31 year old male

Reactions: Death, T-Lymphocyte Count Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Crixivan
    Administration route: Oral
    Indication: Acquired Immunodeficiency Syndrome

Isentress
    Administration route: Oral
    Indication: Acquired Immunodeficiency Syndrome



Possible Crixivan side effects in 31 year old male

Reported by a physician from United States on 2012-06-13

Patient: 31 year old male

Reactions: Death, T-Lymphocyte Count Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Crixivan
    Administration route: Oral
    Indication: Acquired Immunodeficiency Syndrome

Isentress
    Administration route: Oral
    Indication: Acquired Immunodeficiency Syndrome



Possible Crixivan side effects in 49 year old female

Reported by a physician from Italy on 2012-04-02

Patient: 49 year old female

Reactions: Ischaemia, Immune Reconstitution Syndrome, Dementia, Central Nervous System Lesion, Hypoaesthesia, Pyrexia, Hemiparesis, Pupils Unequal, Decreased Vibratory Sense, Rhodococcus Infection, Cerebellar Syndrome, Convulsion, Diarrhoea, Nervous System Disorder, Abscess, Thrombocytopenia, Cough

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Crixivan
    Administration route: Oral
    Start date: 2002-06-01

Crixivan
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2001-10-01
    End date: 2002-05-01

Didanosine
    Start date: 2002-06-01

Didanosine
    Indication: HIV Infection
    Start date: 2001-10-01
    End date: 2002-05-01

Lamivudine
    Indication: HIV Infection
    Start date: 2001-10-01
    End date: 2002-05-01

Lamivudine
    Start date: 2002-06-01

Other drugs received by patient: Prednisone



Possible Crixivan side effects in 54 year old male

Reported by a consumer/non-health professional from Canada on 2012-02-22

Patient: 54 year old male

Reactions: Diplopia, Dysphagia, Mitochondrial Toxicity, Progressive External Ophthalmoplegia, Eyelid Ptosis, Lipodystrophy Acquired, Blood Lactic Acid Increased

Drug(s) suspected as cause:
Crixivan
    Administration route: Oral

Fuzeon

Kaletra

Lamivudine

Lamivudine

Lamivudine

Reyataz

Reyataz

Ritonavir

Saquinavir

Videx

Videx

Videx

Viramune

Viramune

Viramune

Viread

Zerit

Ziagen

Zidovudine



Possible Crixivan side effects in 24 year old male

Reported by a consumer/non-health professional from United States on 2011-12-07

Patient: 24 year old male

Reactions: Pulmonary Hypertension, Palpitations, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Dizziness

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Crixivan
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-03-18
    End date: 2000-05-24

Efavirenz
    Dosage: 24-25jul00(2d)-600mg 25sep00-02oct00(8d)
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2000-10-02

Epivir
    Dosage: tab
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-05-15
    End date: 2008-09-19

Invirase
    Dosage: caps; 19jun99-18mar00(274d) 24may00-24dec00(215d)800mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 2000-12-24

Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-12-25
    End date: 2004-04-24

Norvir
    Dosage: 19jun-31oct99;400mg 01nov99-24dec00;420d 100mg/d 24apr05-19sep08;1244d 200mg/d 20sep08-cont
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19

Videx
    Dosage: 19dec94-7mar97(125mg)810d 8mar97-21jul01(300mg)1597d 22jul-14may04(400mg)1028d
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1994-11-19
    End date: 2004-05-14

Zerit
    Dosage: 25aug97-27feb98(187d) 27feb-03aug98(158) 3aug-9nov(99) 9nov98-19jn99(223) 25dc00-20oc01(300d)
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1997-08-25
    End date: 2001-10-20

Ziagen
    Dosage: 24jul-25jul00(2d)600mg 20oct-27oct01(8d)600mg interrupted on 25jul00
    Administration route: Oral
    Start date: 2000-07-24
    End date: 2001-10-27

Other drugs received by patient: Cross Eight M



Possible Crixivan side effects in 24 year old male

Reported by a individual with unspecified qualification from Japan on 2011-12-06

Patient: 24 year old male

Reactions: Pulmonary Hypertension, Palpitations, Dizziness, Apparent Life Threatening Event

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Crixivan
    Dosage: 800 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-03-18
    End date: 2000-05-24

Efavirenz
    Dosage: 600 mg/daily po ; 600 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-09-25
    End date: 2000-10-02

Efavirenz
    Dosage: 600 mg/daily po ; 600 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2000-07-25

Invirase
    Dosage: 400 mg/bid po ; 800 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 2000-03-18

Invirase
    Dosage: 400 mg/bid po ; 800 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-05-24
    End date: 2000-12-24

Kaletra
    Dosage: 6 dose/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-12-25
    End date: 2004-04-24

Lamivudine
    Dosage: 300 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-05-15
    End date: 2008-09-19

Norvir
    Dosage: 400 mg/bid po ; 800 mg/daily po ; 100 mg/daily po ; 200 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 1999-10-31

Norvir
    Dosage: 400 mg/bid po ; 800 mg/daily po ; 100 mg/daily po ; 200 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-09-20

Norvir
    Dosage: 400 mg/bid po ; 800 mg/daily po ; 100 mg/daily po ; 200 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-04-25
    End date: 2008-09-19

Norvir
    Dosage: 400 mg/bid po ; 800 mg/daily po ; 100 mg/daily po ; 200 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-11-01
    End date: 2000-12-24

Videx
    Dosage: 400 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2001-07-21
    End date: 2004-05-14

Videx
    Dosage: 125 mg/bid po ; 300 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1994-12-19
    End date: 1997-03-07

Videx
    Dosage: 125 mg/bid po ; 300 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1997-03-07
    End date: 2001-07-21

Zerit
    Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1998-02-27
    End date: 1998-08-03

Zerit
    Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1997-08-25
    End date: 1998-02-27

Zerit
    Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1998-08-03
    End date: 1998-11-09

Zerit
    Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1998-11-09
    End date: 1999-06-19

Zerit
    Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-12-25
    End date: 2001-10-20

Ziagen
    Dosage: 600 mg/daily po ; 600 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2000-07-25

Ziagen
    Dosage: 600 mg/daily po ; 600 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2001-10-20
    End date: 2001-10-27

Other drugs received by patient: Antihemophilic Factor (Human)



Possible Crixivan side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2011-12-05

Patient: male

Reactions: Hydronephrosis, Pain

Drug(s) suspected as cause:
Crixivan

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