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STAVUDINE

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Stavudine Adverse Events Reported to the FDA Over Time

How are Stavudine adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Stavudine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Stavudine is flagged as the suspect drug causing the adverse event.

Most Common Stavudine Adverse Events Reported to the FDA

What are the most common Stavudine adverse events reported to the FDA?

Immune Reconstitution Syndrome
275 (3.16%)
Lactic Acidosis
182 (2.09%)
Vomiting
148 (1.7%)
Lipodystrophy Acquired
137 (1.57%)
Pyrexia
104 (1.19%)
Nausea
102 (1.17%)
Drug Exposure During Pregnancy
97 (1.11%)
Anaemia
85 (.98%)
Mitochondrial Toxicity
85 (.98%)
Eyelid Ptosis
84 (.97%)
Abdominal Pain
76 (.87%)
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Diarrhoea
73 (.84%)
Pancreatitis
70 (.8%)
Neuropathy Peripheral
66 (.76%)
Portal Hypertension
66 (.76%)
Drug Ineffective
64 (.74%)
Drug Resistance
63 (.72%)
Hyperlactacidaemia
63 (.72%)
Dyspnoea
59 (.68%)
Pregnancy
59 (.68%)
Aspartate Aminotransferase Increase...
58 (.67%)
Diplopia
53 (.61%)
Progressive External Ophthalmoplegi...
53 (.61%)
Alanine Aminotransferase Increased
52 (.6%)
Death
50 (.57%)
Hepatic Steatosis
50 (.57%)
Ascites
45 (.52%)
Asthenia
45 (.52%)
Gamma-glutamyltransferase Increased
45 (.52%)
Hepatotoxicity
45 (.52%)
Malaise
45 (.52%)
Lymphadenopathy
43 (.49%)
Weight Decreased
43 (.49%)
Tuberculosis
42 (.48%)
Fatigue
41 (.47%)
Lipoatrophy
41 (.47%)
General Physical Health Deteriorati...
40 (.46%)
Drug Interaction
39 (.45%)
Headache
39 (.45%)
Osteonecrosis
39 (.45%)
Dehydration
38 (.44%)
Hepatomegaly
38 (.44%)
Rash
38 (.44%)
Viral Mutation Identified
37 (.43%)
Abortion Spontaneous
36 (.41%)
Blood Alkaline Phosphatase Increase...
35 (.4%)
Hepatic Failure
35 (.4%)
Muscular Weakness
35 (.4%)
Hepatic Fibrosis
34 (.39%)
Neutropenia
34 (.39%)
Portal Hypertensive Gastropathy
34 (.39%)
Progressive Multifocal Leukoencepha...
32 (.37%)
Anorexia
31 (.36%)
Condition Aggravated
31 (.36%)
Metabolic Acidosis
31 (.36%)
Oesophageal Varices Haemorrhage
31 (.36%)
Blood Bilirubin Increased
30 (.34%)
Chest Pain
30 (.34%)
Hypertriglyceridaemia
30 (.34%)
Pulmonary Tuberculosis
30 (.34%)
Drug Toxicity
29 (.33%)
Premature Baby
29 (.33%)
Blood Triglycerides Increased
28 (.32%)
Hepatitis
28 (.32%)
Jaundice
28 (.32%)
Meningitis Cryptococcal
28 (.32%)
Pneumonia
28 (.32%)
Splenomegaly
28 (.32%)
Thrombocytopenia
28 (.32%)
Gastritis
27 (.31%)
Hepatic Cirrhosis
27 (.31%)
Varices Oesophageal
27 (.31%)
Cough
26 (.3%)
Myalgia
26 (.3%)
Renal Failure
26 (.3%)
Blood Lactic Acid Increased
25 (.29%)
Portal Vein Thrombosis
25 (.29%)
Tachypnoea
25 (.29%)
Facial Wasting
24 (.28%)
Nodular Regenerative Hyperplasia
24 (.28%)
Respiratory Distress
24 (.28%)
Stillbirth
24 (.28%)
Confusional State
23 (.26%)
Liver Disorder
23 (.26%)
White Blood Cell Count Decreased
23 (.26%)
Depression
22 (.25%)
Hyperbilirubinaemia
22 (.25%)
Cardiac Failure
21 (.24%)
Haemoglobin Decreased
21 (.24%)
Hyperglycaemia
21 (.24%)
Sepsis
21 (.24%)
Skin Lesion
21 (.24%)
Cachexia
20 (.23%)
Hyperlipidaemia
20 (.23%)
Hypertension
20 (.23%)
Renal Failure Acute
20 (.23%)
Tachycardia
20 (.23%)
Convulsion
19 (.22%)
Cryptococcosis
19 (.22%)
Hepatic Function Abnormal
19 (.22%)
Ophthalmoplegia
19 (.22%)

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This graph shows the top adverse events submitted to the FDA for Stavudine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Stavudine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Stavudine

What are the most common Stavudine adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Stavudine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Stavudine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Stavudine According to Those Reporting Adverse Events

Why are people taking Stavudine, according to those reporting adverse events to the FDA?

Hiv Infection
2396
Antiretroviral Therapy
139
Drug Use For Unknown Indication
97
Acquired Immunodeficiency Syndrome
71
Drug Exposure During Pregnancy
43
Hiv Test Positive
32
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Antiviral Prophylaxis
30
Systemic Antiviral Treatment
23
Prophylaxis Against Hiv Infection
18
Retroviral Infection
18
Product Used For Unknown Indication
17
Hepatitis B
16
Human Immunodeficiency Virus Transm...
15
Prophylaxis
13
Ill-defined Disorder
6
Kaposis Sarcoma Aids Related
6
Hepatic Cirrhosis
5
Hiv Infection Cdc Category C3
5
Hepatitis C
4
Acute Hiv Infection
4
Adverse Event
3
Hiv Infection Who Clinical Stage I
3
Hiv Infection Who Clinical Stage Ii
2
Pneumocystis Jiroveci Infection
2
End Stage Aids
2
Urticaria
2
Infection Prophylaxis
2
Vertical Infection Transmission
2
Hiv Infection Cdc Group Iii
2
Antiviral Treatment
2
Suicide Attempt
2
Drug Exposure Via Breast Milk
1
Psoriasis
1
Hepatitis B Virus Test
1
Kaposis Sarcoma
1
Maternal Exposure During Pregnancy
1
Hiv Infection Cdc Group I
1
Pancreatitis
1
Hiv Infection Cdc Category A3
1
Hiv Infection Cdc Category B2
1
Paternal Drugs Affecting Foetus
1
Intentional Self-injury
1
Hiv Antibody Positive
1
Tuberculosis
1
Hiv Infection Cdc Category B3
1
Hiv Infection Who Clinical Stage Iv
1

Drug Labels

LabelLabelerEffective
StavudineCamber Pharmaceuticals, Inc.20-JUL-09
StavudineGreenstone LLC03-FEB-10
StavudineKAISER FOUNDATION HOSPITALS08-MAR-10
StavudineState of Florida DOH Central Pharmacy08-JUN-10
StavudineState of Florida DOH Central Pharmacy08-JUN-10
ZeritState of Florida DOH Central Pharmacy12-AUG-10
StavudineREMEDYREPACK INC. 11-NOV-10
StavudineCipla Limited08-DEC-11
StavudineMylan Pharmaceuticals Inc.05-JAN-12
StavudineAurobindo Pharma Limited12-JAN-12
StavudineEdenbridge Pharmaceuticals, LLC01-APR-12
StavudineBoca Pharmacal Inc.24-MAY-12
StavudineAurobindo Pharma Limited12-NOV-12
ZeritE.R. Squibb & Sons, L.L.C.01-DEC-12

Stavudine Case Reports

What Stavudine safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Stavudine. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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