This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Combivir (Lamivudine / Zidovudine) 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 (461)
Death (49)
Life Threatening Events (20)
Disability (5)
Reports by Reaction Type
Foetal Exposure During Pregnancy (173),
Maternal Exposure During Pregnancy (105),
Premature Baby (68),
Abortion Spontaneous (65),
Stillbirth (33),
Anaemia (28),
Atrial Septal Defect (25),
Foetal Growth Restriction (24),
Talipes (23),
Single Umbilical Artery (18),
Heart Disease Congenital (18),
Hydronephrosis (17)
Below are a few examples of reports where side effects / adverse reactions may be related to Combivir (Lamivudine / Zidovudine). For a complete list or a specific selection of reports, please use the links above.
Possible Combivir side effects in male
Reported by a physician from France on 2012-08-27
Patient: male
Reactions: Eyelid Oedema, Lymphadenopathy, Skin Exfoliation, Conjunctivitis, Tachycardia, Scab, Pyrexia, Cheilitis, Penile Ulceration, Face Oedema, Scrotal Oedema, Optic Disc Haemorrhage, Myocarditis, Stevens-Johnson Syndrome, Dysphagia, N-Terminal Prohormone Brain Natriuretic Peptide Increased, Troponin Increased, LIP Haemorrhage, Drug Rash With Eosinophilia and Systemic Symptoms, Anal Erosion, Mucosal Erosion, Cardiac Failure, Cytomegalovirus Chorioretinitis, Epidermal Necrosis, Electrocardiogram Abnormal, Oedema Genital, Rash Maculo-Papular
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sulfadiazine
Dosage: 6g per day
Administration route: Oral
Indication: Cerebral Toxoplasmosis
Start date: 2012-06-18
End date: 2012-07-09
Prezista
Dosage: 400mg twice per day
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-27
End date: 2012-07-04
Fluconazole
Dosage: 100mg per day
Administration route: Oral
Indication: Oesophageal Candidiasis
Start date: 2012-06-08
End date: 2012-06-30
Combivir
Dosage: 1tab twice per day
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-27
End date: 2012-07-04
Bactrim
Dosage: 1unit per day
Administration route: Oral
Indication: Antifungal Prophylaxis
Start date: 2012-06-12
End date: 2012-07-05
Norvir
Dosage: 100mg per day
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-27
End date: 2012-07-04
Other drugs received by patient: Malocide; Folinate
Possible Combivir side effects in male
Reported by a physician from France on 2012-08-27
Patient: male
Reactions: Myalgia, Burning Sensation, Amyotrophy, Decreased Appetite
Drug(s) suspected as cause:
Combivir
Dosage: 1unit twice per day
Administration route: Oral
Indication: HIV Infection
Start date: 2002-10-17
End date: 2012-06-03
Kaletra
Dosage: 2tab twice per day
Administration route: Oral
Indication: HIV Infection
Start date: 2002-10-17
End date: 2012-06-15
Possible Combivir side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient:
Reactions: Foetal Chromosome Abnormality, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Vertical Talus
Drug(s) suspected as cause:
Truvada
Dosage: 1 df, unk
Start date: 2011-07-13
End date: 2011-10-27
Reyataz
Dosage: 300 mg, qd
Start date: 2011-07-13
End date: 2011-10-27
Combivir
Dosage: 2 df, unk
Start date: 2011-11-21
Norvir
Dosage: 100 mg, qd
Start date: 2011-07-13
End date: 2011-10-27
Isentress
Dosage: 800 mg, qd
Start date: 2011-11-21
Possible Combivir side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27
Patient: male
Reactions: Haemoglobin Decreased, Drug Rash With Eosinophilia and Systemic Symptoms, Blood Sodium Decreased, Myocarditis, Blood Creatinine Increased, Stevens-Johnson Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prezista
Dosage: 2 tablets at 400 mg a day
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-27
End date: 2012-07-04
Bactrim
Dosage: 2 tablets a day
Administration route: Oral
Indication: Antifungal Prophylaxis
Start date: 2012-06-12
End date: 2012-07-05
Fluconazole
Dosage: 2 tablets a day
Administration route: Oral
Indication: Oesophageal Candidiasis
Start date: 2012-06-08
End date: 2012-06-30
Combivir
Dosage: 2 tablets a day
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-27
End date: 2012-07-04
Sulfadiazine
Dosage: 2 tablets a day
Administration route: Oral
Indication: Cerebral Toxoplasmosis
Start date: 2012-06-18
End date: 2012-07-09
Norvir
Dosage: 2 tablets a day
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-27
End date: 2012-07-04
Possible Combivir side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient:
Reactions: Ultrasound Scan Abnormal, Foetal Exposure During Pregnancy, Abortion Induced, Talipes, Meningomyelocele
Adverse event resulted in: death
Drug(s) suspected as cause:
Combivir
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
Possible Combivir side effects in male
Reported by a physician from France on 2012-08-24
Patient: male
Reactions: Dysphagia, Cytomegalovirus Chorioretinitis, Drug Hypersensitivity, Conjunctivitis, Drug Rash With Eosinophilia and Systemic Symptoms, Myocarditis, Stevens-Johnson Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bactrim
Administration route: Oral
Indication: Pneumocystis Jiroveci Pneumonia
Start date: 2012-06-12
End date: 2012-07-05
Sulfadiazine
Administration route: Oral
Indication: Cerebral Toxoplasmosis
Start date: 2012-06-18
End date: 2012-07-09
Bactrim
Indication: Prophylaxis
Combivir
Indication: HIV Infection
Start date: 2012-06-27
End date: 2012-07-04
Norvir
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-27
End date: 2012-07-04
Prezista
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-27
End date: 2012-07-04
Fluconazole
Administration route: Oral
Indication: Oesophageal Candidiasis
Start date: 2012-06-08
End date: 2012-06-30
Possible Combivir side effects in female
Reported by a physician from France on 2012-08-24
Patient: female
Reactions: Cholestasis of Pregnancy, Maternal Exposure During Pregnancy, Adverse Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kaletra
Dosage: 2tab twice per day
Administration route: Oral
Indication: Antiviral Prophylaxis
Start date: 2012-03-19
End date: 2012-05-24
Abacavir Sulfate / Lamivudine
Dosage: 1tab per day
Administration route: Oral
Indication: Antiviral Prophylaxis
Start date: 2012-03-05
End date: 2012-03-19
Combivir
Dosage: 1tab twice per day
Administration route: Oral
Indication: Antiviral Prophylaxis
Start date: 2012-03-19
End date: 2012-05-24
Possible Combivir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: male
Reactions: Foetal Exposure During Pregnancy, Congenital Anomaly
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Combivir
Indication: Maternal Exposure Timing Unspecified
Possible Combivir side effects in 58 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23
Patient: 58 year old male
Reactions: Tachycardia, Transferrin Decreased, Cerebral Toxoplasmosis, Transferrin Saturation Decreased, Eye Haemorrhage, Gamma-Glutamyltransferase Increased, Blood Sodium Decreased, Myocarditis, Electrocardiogram Repolarisation Abnormality, Stevens-Johnson Syndrome, Blood Iron Decreased, Blood Lactate Dehydrogenase Increased, Renal Cyst, Drug Rash With Eosinophilia and Systemic Symptoms, Nephrotic Syndrome, Renal Failure, Cytomegalovirus Chorioretinitis, Electrocardiogram ST Segment Elevation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bactrim
Dosage: 1 tablet, 1x/day
Administration route: Oral
Indication: Antifungal Prophylaxis
Start date: 2012-06-12
End date: 2012-07-05
Norvir
Dosage: 100 mg, 1x/day (1 df)
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-27
End date: 2012-07-04
Sulfadiazine
Dosage: 6 g, 1x/day
Administration route: Oral
Indication: Cerebral Toxoplasmosis
Start date: 2012-06-18
End date: 2012-07-09
Combivir
Dosage: 1 df, 2x/day
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-27
End date: 2012-07-04
Fluconazole
Dosage: 100 mg, 1x/day
Administration route: Oral
Indication: Oesophageal Candidiasis
Start date: 2012-06-08
End date: 2012-06-30
Prezista
Dosage: 400 mg, 1x/day
Administration route: Oral
Indication: HIV Infection
Start date: 2012-06-27
End date: 2012-07-04
Other drugs received by patient: Malocide; Malocide; Calcium Folinate; Malocide
Possible Combivir side effects in 26 year old female
Reported by a physician from United States on 2012-08-23
Patient: 26 year old female
Reactions: Prenatal Screening Test Abnormal, Maternal Exposure During Pregnancy, Abortion Induced
Drug(s) suspected as cause:
Truvada
Dosage: 1tab per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-07-13
End date: 2011-10-27
Reyataz
Dosage: 300mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-07-13
End date: 2011-10-27
Norvir
Dosage: 100mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-07-13
End date: 2011-10-27
Combivir
Dosage: 2tab per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-11-21
Raltegravir
Dosage: 800mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-11-21
Possible Combivir side effects in
Reported by a physician from United States on 2012-08-23
Patient: , weighing 1.9 kg (4.2 pounds)
Reactions: Foetal Exposure During Pregnancy, Congenital Foot Malformation
Drug(s) suspected as cause:
Norvir
Dosage: 100mgd per day
Indication: Antiretroviral Therapy
Start date: 2011-07-13
End date: 2011-10-27
Truvada
Dosage: 1tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-13
End date: 2011-10-27
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-11-21
Raltegravir
Dosage: 800mgd per day
Indication: Antiretroviral Therapy
Start date: 2011-11-21
Reyataz
Dosage: 300mgd per day
Indication: Antiretroviral Therapy
Start date: 2011-07-13
End date: 2011-10-27
Possible Combivir side effects in male
Reported by a physician from France on 2012-08-22
Patient: male
Reactions: Myalgia, Burning Sensation, Amyotrophy, Decreased Appetite
Drug(s) suspected as cause:
Combivir
Dosage: dosage form: 150/300 mg, 2 in 1 day
Administration route: Oral
Indication: HIV Infection
Start date: 2002-10-17
End date: 2012-06-03
Kaletra
Administration route: Oral
Indication: HIV Infection
Start date: 2002-10-17
End date: 2012-06-15
Possible Combivir side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient:
Reactions: Atrial Septal Defect, Jaundice, Cardiac Murmur, Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Anaemia, Ascites, Hydrops Foetalis, Talipes
Drug(s) suspected as cause:
Combivir
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
Possible Combivir side effects in 46 year old female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 46 year old female, weighing 68.0 kg (149.6 pounds)
Reactions: Renal Colic
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Combivir
Administration route: Oral
Indication: HIV Infection
Start date: 2009-10-19
Combivir
Dosage: 1 df=150/300mg,last dose:04oct2010
Administration route: Oral
Start date: 2009-10-19
Atazanavir
Dosage: last dose:04oct2010
Administration route: Oral
Indication: HIV Infection
Start date: 2010-02-18
Other drugs received by patient: Ketoprofen; Metoclopramide; Morphine; Diazepam; Ketoprofen; Orphenadrine Citrate; Scopolamine; Diazepam; Phenergan; Ketoprofen; Scopolamine; Dipirone; Orphenadrine Citrate; Caffeine + Dipyrone; Hyoscine HBR HYT; Ramipril; Metoclopramide; Hyoscine HBR HYT; Dipirone; Morphine; Phenergan; Codeine Phosphate and Acetaminophen; Caffeine + Dipyrone; Codeine Phosphate and Acetaminophen; Ciprofloxacin
Possible Combivir side effects in
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient:
Reactions: Foetal Exposure During Pregnancy, Plagiocephaly
Drug(s) suspected as cause:
Isentress
Combivir
Possible Combivir side effects in male
Reported by a consumer/non-health professional from Russian Federation on 2012-08-20
Patient: male
Reactions: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Pain
Drug(s) suspected as cause:
Efavirenz
Administration route: Oral
Indication: HIV Infection
Start date: 2012-07-01
Combivir
Administration route: Oral
Indication: HIV Infection
Start date: 2012-07-01
Possible Combivir side effects in female
Reported by a pharmacist from France on 2012-08-20
Patient: female
Reactions: Cholestasis of Pregnancy, Gestational Diabetes, Adverse Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kaletra
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-19
End date: 2012-05-24
Combivir
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-19
End date: 2012-05-24
Other drugs received by patient: Isentress; Truvada
Possible Combivir side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20
Patient:
Reactions: Ultrasound Scan Abnormal, Foetal Exposure During Pregnancy, Abortion Induced, Talipes, Meningomyelocele
Adverse event resulted in: death
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Combivir
Indication: Maternal Exposure Timing Unspecified
Possible Combivir side effects in male
Reported by a physician from United States on 2012-08-17
Patient: male, weighing 2.9 kg (6.4 pounds)
Reactions: Prenatal Screening Test Abnormal, Drug Screen Positive, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Combivir
Dosage: 2tab per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-05-10
Kaletra
Dosage: 4tab per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-05-10
Other drugs received by patient: Cocaine; Tetrahydrocannabinol
Possible Combivir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: male, weighing 2.0 kg (4.4 pounds)
Reactions: Trisomy 21, Premature Baby, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Limb Malformation, Acoustic Stimulation Tests Abnormal
Drug(s) suspected as cause:
Viramune
Dosage: 400mgd per day
Indication: Antiretroviral Therapy
Retrovir
Dosage: 2mgkh per day
Indication: Antiretroviral Therapy
Start date: 2011-10-07
End date: 2011-10-07
Zerit
Dosage: 40mgd per day
Indication: Antiretroviral Therapy
End date: 2011-07-15
Epivir
Dosage: 300mgd per day
Indication: Antiretroviral Therapy
End date: 2011-07-15
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-15
Possible Combivir side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient:
Reactions: Cytogenetic Abnormality, Brain Malformation, Spina Bifida, Abortion Induced, Vertical Talus
Adverse event resulted in: death
Drug(s) suspected as cause:
Isentress
Indication: Maternal Exposure Timing Unspecified
Norvir
Indication: Maternal Exposure Timing Unspecified
Combivir
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Possible Combivir side effects in male
Reported by a physician from United States on 2012-08-17
Patient: male, weighing 3.7 kg (8.1 pounds)
Reactions: Hydronephrosis, Foetal Exposure During Pregnancy, Congenital Megaureter, Pyelocaliectasis
Drug(s) suspected as cause:
Truvada
Dosage: 1tab per day
Indication: Antiretroviral Therapy
End date: 2011-11-10
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-11-10
End date: 2012-06-07
Norvir
Dosage: 100mgd per day
Indication: Antiretroviral Therapy
Reyataz
Dosage: 300mgd per day
Indication: Antiretroviral Therapy
Other drugs received by patient: Retrovir; Fluconazole; Terazol Cream; Retrovir; Unspecified Medication
Possible Combivir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: male, weighing 3.7 kg (8.2 pounds)
Reactions: Hydronephrosis, Foetal Exposure During Pregnancy, Congenital Megaureter, Pyelocaliectasis
Drug(s) suspected as cause:
Norvir
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Combivir
Indication: Maternal Exposure Timing Unspecified
Possible Combivir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: male
Reactions: Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Atripla
Indication: Maternal Exposure Timing Unspecified
Combivir
Indication: Maternal Exposure Timing Unspecified
Possible Combivir side effects in 32 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-16
Patient: 32 year old female, weighing 68.0 kg (149.6 pounds)
Reactions: Abortion Missed, Pregnancy
Adverse event resulted in: death
Drug(s) suspected as cause:
Efavirenz
Dosage: 600 mg, qd
Administration route: Oral
Indication: HIV Infection
Start date: 2003-05-29
Septra
Dosage: 480 mg, qd
Administration route: Oral
Indication: Antifungal Prophylaxis
Start date: 2003-04-29
End date: 2009-08-04
Acyclovir
Dosage: 800 mg
Administration route: Oral
Indication: Antiviral Prophylaxis
Start date: 2003-04-29
Combivir
Dosage: 1 df, qd
Administration route: Oral
Indication: HIV Infection
Start date: 2003-05-29
Possible Combivir side effects in
Reported by a physician from United States on 2012-08-15
Patient:
Reactions: Foetal Exposure During Pregnancy, Foetal Death, Nervous System Disorder, Heart Disease Congenital, Single Umbilical Artery
Adverse event resulted in: death
Drug(s) suspected as cause:
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Kaletra
Dosage: 4tab per day
Indication: Antiretroviral Therapy
Possible Combivir side effects in male
Reported by a physician from Japan on 2012-08-15
Patient: male
Reactions: Renal Function Test Abnormal, Hyperkalaemia
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Combivir
Administration route: Oral
Start date: 2012-01-16
Combivir
Administration route: Oral
Indication: HIV Infection
Start date: 2004-04-01
End date: 2011-12-22
Reyataz
Dosage: 300-400 mg/day
Administration route: Oral
Indication: HIV Infection
Start date: 2004-04-01
End date: 2011-12-22
Norvir
Start date: 2011-12-24
Reyataz
Dosage: 300-400 mg/day
Administration route: Oral
Start date: 2011-12-24
Norvir
Indication: HIV Infection
Start date: 2005-10-06
End date: 2011-12-22
Other drugs received by patient: Allopurinol
Possible Combivir side effects in
Reported by a physician from United States on 2012-08-15
Patient:
Reactions: Foetal Exposure During Pregnancy, Nervous System Disorder, Foetal Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Kaletra
Dosage: 4tab per day
Indication: Antiretroviral Therapy
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Possible Combivir side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15
Patient:
Reactions: Congenital Aortic Stenosis, Dandy-Walker Syndrome, Premature Baby, Foetal Exposure During Pregnancy, Congenital Pulmonary Artery Anomaly, Sepsis, Foetal Heart Rate Abnormal, Heart Disease Congenital, Talipes
Adverse event resulted in: death
Drug(s) suspected as cause:
Kaletra
Dosage: 4tab per day
Indication: HIV Infection
Start date: 2010-08-30
Combivir
Dosage: 2tab per day
Indication: HIV Infection
Start date: 2010-08-30
Possible Combivir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15
Patient: male
Reactions: Premature Baby, Hypotonia Neonatal, Foetal Exposure During Pregnancy, Congenital Myopathy
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Combivir
Indication: Maternal Exposure Timing Unspecified
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