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),
Nephrotic Syndrome (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 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 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 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 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 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 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
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 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 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 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 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: 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 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 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
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 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 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 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 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 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 health professional (non-physician/pharmacist) from United States on 2012-06-07
Patient:
Reactions: Drug Screen Positive
Drug(s) suspected as cause:
Sustiva
Possible Sustiva side effects in
Reported by a consumer/non-health professional from United States on 2012-06-07
Patient:
Reactions: Rash
Drug(s) suspected as cause:
Sustiva
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