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Sustiva (Efavirenz) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sustiva (Efavirenz) 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 (150)
Death (2)
Life Threatening Events (8)
Disability (2)

Reports by Reaction Type

Polyhydramnios (9)Lipodystrophy Acquired (8)Rash (7)Nervous System Disorder (7)Tubulointerstitial Nephritis (6)Foetal Exposure During Pregnancy (6)Cholestasis (6)Glomerulonephritis Membranous (6)Polyneuropathy (6)Adverse Event (6)Drug Resistance (6)Eosinophilia (6)

Below are a few examples of reports where side effects / adverse reactions may be related to Sustiva (Efavirenz). For a complete list or a specific selection of reports, please use the links above.

Possible Sustiva side effects in 57 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 57 year old male

Reactions: Renal Disorder, Gastrointestinal Disorder, Viral Mutation Identified

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

Truvada
    Indication: HIV Infection



Possible Sustiva side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-21

Patient: 49 year old female

Reactions: Dehydration, Orthostatic Hypotension, Oedema, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sustiva
    Dosage: 1 df, qd
    Indication: HIV Infection
    Start date: 2012-07-17
    End date: 2012-07-23

Truvada
    Dosage: 1 df, qd
    Indication: HIV Infection
    Start date: 2012-07-17
    End date: 2012-07-23



Possible Sustiva side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: 66 year old male

Reactions: Sialoadenitis, Salivary Gland Calculus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-05-01

Pravastatin
    Administration route: Oral

Sustiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-01
    End date: 2010-05-01

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-01
    End date: 2010-05-01



Possible Sustiva side effects in 58 year old male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 58 year old male

Reactions: Intestinal Malrotation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sustiva



Possible Sustiva side effects in 66 year old male

Reported by a consumer/non-health professional from France on 2012-08-13

Patient: 66 year old male

Reactions: Sialoadenitis, Salivary Gland Calculus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla
    Administration route: Oral
    Start date: 2010-05-01

Pravastatin
    Administration route: Oral

Sustiva
    Administration route: Oral
    Start date: 2008-07-01
    End date: 2010-05-01

Truvada
    Administration route: Oral
    Start date: 2008-07-01
    End date: 2010-05-01



Possible Sustiva side effects in

Reported by a physician from United States on 2012-08-10

Patient:

Reactions: Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress
    Dosage: unk
    Administration route: Oral

Sustiva
    Dosage: 400 mg, qpm
    Administration route: Oral

Ziagen
    Dosage: 300 mg, bid
    Administration route: Oral



Possible Sustiva side effects in male

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

Patient: male

Reactions: Salivary Gland Calculus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-05-01

Pravastatin Sodium
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sustiva
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-01
    End date: 2010-05-01

Truvada
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-01
    End date: 2010-05-01



Possible Sustiva side effects in male

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

Patient: male

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Emtricitabine / Tenofovir Disoproxil Fumarate
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-24
    End date: 2011-03-21

Lamivudine + Zidovudine
    Dosage: 2 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-03-21

Lopinavir / Ritonavir
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-03-21

Sustiva
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-10-01
    End date: 2011-03-21



Possible Sustiva side effects in male

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

Patient: male, weighing 2.3 kg (5.1 pounds)

Reactions: Prenatal Screening Test Abnormal, Premature Baby, Foetal Exposure During Pregnancy, Polyhydramnios

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiviral Treatment
    Start date: 2011-03-21

Kaletra
    Dosage: 6tab per day
    Indication: Antiviral Treatment
    Start date: 2011-03-21

Sustiva
    Dosage: 600mg per day
    Indication: Antiviral Treatment
    Start date: 2008-10-01
    End date: 2011-03-21

Truvada
    Dosage: 1tab per day
    Indication: Antiviral Treatment
    Start date: 2008-07-24
    End date: 2011-03-21



Possible Sustiva side effects in 18 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 18 year old female

Reactions: Polyhydramnios, Pregnancy

Drug(s) suspected as cause:
Emtricitabine / Tenofovir Disoproxil Fumarate
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-24
    End date: 2011-03-21

Lamivudine + Zidovudine
    Dosage: 2 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-03-21

Lopinavir / Ritonavir
    Dosage: 6 df, unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-03-21

Sustiva
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-10-01
    End date: 2011-03-21



Possible Sustiva side effects in male

Reported by a physician from United States on 2012-08-03

Patient: male

Reactions: Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress
    Dosage: tabs
    Administration route: Oral

Sustiva
    Dosage: dose reduced

Ziagen
    Administration route: Oral



Possible Sustiva side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-02

Patient: male

Reactions: Salivary Gland Calculus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-05-01

Pravastatin Sodium
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sustiva
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-01
    End date: 2010-05-01

Truvada
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-01
    End date: 2010-05-01



Possible Sustiva side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: male

Reactions: Adverse Event

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Atripla

Sustiva



Possible Sustiva side effects in

Reported by a physician from United States on 2012-07-31

Patient:

Reactions: Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sustiva
    Dosage: 400 mg, qd
    Indication: Product Used FOR Unknown Indication

Ziagen
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Sustiva side effects in 50 year old male

Reported by a physician from United Kingdom on 2012-07-20

Patient: 50 year old male

Reactions: Cholelithiasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sustiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-11-04

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-04-12

Other drugs received by patient: Pravastatin; Zolpidem Tartrate; Plavix; Perindopril Erbumine; Subutex; Nebivolol HCL



Possible Sustiva side effects in 50 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-07-20

Patient: 50 year old male

Reactions: Pancreatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sustiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-11-04

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-04-12

Other drugs received by patient: Nebivolol HCL; Pravastatin; Subutex; Plavix; Perindopril Erbumine; Zolpidem Tartrate



Possible Sustiva side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: male

Reactions: Liver Disorder

Adverse event resulted in: hospitalization

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

Sustiva
    Dosage: 400mg at night
    Indication: Product Used FOR Unknown Indication

Ziagen
    Dosage: 300mg twice per day
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Polypharmacy



Possible Sustiva side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-12

Patient: male

Reactions: Cholelithiasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sustiva
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2002-11-04

Truvada
    Dosage: 1 df, qd
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-04-12

Other drugs received by patient: Plavix; Coversyl / 00790702 /; Zolpidem Tartrate; Vasten / 00880402 /; Nebivolol HCL; Subutex



Possible Sustiva side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-12

Patient: male

Reactions: Pancreatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sustiva
    Dosage: 1 df, qd
    Indication: HIV Infection
    Start date: 2002-11-04

Truvada
    Dosage: 1 df, qd
    Indication: HIV Infection
    Start date: 2006-04-12

Other drugs received by patient: Nebivolol HCL; Perindopril Erbumine; Plavix; Subutex; Zolpidem Tartrate; Vasten / 00880402 /



Possible Sustiva side effects in 50 year old male

Reported by a consumer/non-health professional from France on 2012-07-11

Patient: 50 year old male

Reactions: Cholelithiasis, Pancreatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sustiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-11-04

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-04-12

Other drugs received by patient: Zolpidem Tartrate; Nebivolol HCL; Plavix; Pravastatin; Perindopril Erbumine; Subutex



Possible Sustiva side effects in 72 year old female

Reported by a consumer/non-health professional from Italy on 2012-07-09

Patient: 72 year old female

Reactions: Confusional State, Irritability, Paraesthesia Oral, Feeling Hot

Drug(s) suspected as cause:
Sustiva

Other drugs received by patient: Aspirin; Trizivir; Abacavir Sulfate / Lamivudine



Possible Sustiva side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-09

Patient:

Reactions: Product Dosage Form Confusion, Medication Error, Drug Name Confusion, Wrong Drug Administered, Intercepted Drug Dispensing Error, Drug Dispensing Error, Drug Prescribing Error

Drug(s) suspected as cause:
Intelence
    Dosage: capsule oral 200 mg
    Administration route: Oral

Sustiva
    Dosage: capsule oral 200 mg
    Administration route: Oral



Possible Sustiva side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-03

Patient: male

Reactions: Cholelithiasis, Pancreatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sustiva
    Dosage: 1 df, unk
    Indication: HIV Infection
    Start date: 2002-11-04

Truvada
    Dosage: 1 df, unk
    Indication: HIV Infection
    Start date: 2006-04-12

Other drugs received by patient: Zolpidem Tartrate; Vasten / 00880402 /; Plavix; Perindopril Erbumine; Subutex; Nebivolol HCL



Possible Sustiva side effects in 40 year old male

Reported by a consumer/non-health professional from France on 2012-06-24

Patient: 40 year old male

Reactions: Papilloma, Helicobacter Gastritis, Pancreatitis Chronic

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-01-01
    End date: 2012-03-28

Sustiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-01-01
    End date: 2012-03-28



Possible Sustiva side effects in male

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

Patient: male, weighing 56.0 kg (123.2 pounds)

Reactions: Flatulence, Mucous Stools, Constipation, Ill-Defined Disorder, Rectal Tenesmus, Abdominal Pain Upper, Hunger, Gastritis, Barrett's Oesophagus, Diarrhoea, Dyspepsia, Pancreatitis Chronic, Gastrooesophageal Reflux Disease, Oesophageal Papilloma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Dosage: 900mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-01-01
    End date: 2012-03-28

Sustiva
    Dosage: 600mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-01-01
    End date: 2012-03-28

Other drugs received by patient: Proton Pump Inhibitor; Amoxicillin; Clarithromycin



Possible Sustiva side effects in 44 year old male

Reported by a consumer/non-health professional from France on 2012-06-18

Patient: 44 year old male

Reactions: Pulmonary Embolism, Lipodystrophy Acquired, Myocardial Infarction

Drug(s) suspected as cause:
Sustiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1998-06-15

Viracept
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1998-06-15
    End date: 1999-01-22



Possible Sustiva side effects in male

Reported by a individual with unspecified qualification from United States on 2012-06-18

Patient: male

Reactions: Psychotic Disorder, Dizziness

Drug(s) suspected as cause:
Sustiva



Possible Sustiva side effects in 55 year old male

Reported by a consumer/non-health professional from United States on 2012-06-11

Patient: 55 year old male

Reactions: Renal Disorder, Hallucination

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

Truvada
    Indication: HIV Infection



Possible Sustiva side effects in

Reported by a pharmacist from United States on 2012-06-07

Patient:

Reactions: Hypersensitivity

Drug(s) suspected as cause:
Reyataz

Sustiva



Possible Sustiva side effects in 43 year old

Reported by a consumer/non-health professional from United States on 2012-06-07

Patient: 43 year old

Reactions: Drug Resistance

Drug(s) suspected as cause:
Sustiva

Other drugs received by patient: Atripla

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