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DIDANOSINE

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Didanosine Adverse Events Reported to the FDA Over Time

How are Didanosine adverse event reports trending over time?

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

Most Common Didanosine Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
170 (2.15%)
Portal Hypertension
140 (1.77%)
Lactic Acidosis
117 (1.48%)
Lipodystrophy Acquired
116 (1.47%)
Vomiting
96 (1.22%)
Eyelid Ptosis
89 (1.13%)
Drug Ineffective
81 (1.03%)
Nausea
76 (.96%)
Mitochondrial Toxicity
74 (.94%)
Ascites
71 (.9%)
Pyrexia
71 (.9%)
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Abortion Spontaneous
69 (.87%)
Pancreatitis
67 (.85%)
Nodular Regenerative Hyperplasia
62 (.79%)
Anaemia
61 (.77%)
Hepatic Failure
61 (.77%)
Pregnancy
61 (.77%)
Immune Reconstitution Syndrome
60 (.76%)
Weight Decreased
59 (.75%)
Drug Toxicity
56 (.71%)
Renal Impairment
56 (.71%)
Drug Resistance
55 (.7%)
Diplopia
53 (.67%)
Drug Interaction
53 (.67%)
Progressive External Ophthalmoplegi...
53 (.67%)
Varices Oesophageal
53 (.67%)
Lymphadenopathy
52 (.66%)
Abdominal Pain
51 (.65%)
Aspartate Aminotransferase Increase...
51 (.65%)
Hypertension
50 (.63%)
Alanine Aminotransferase Increased
48 (.61%)
Hepatic Encephalopathy
47 (.6%)
Hyperlipidaemia
47 (.6%)
Hepatitis
45 (.57%)
Rash
45 (.57%)
Cholestasis
44 (.56%)
Hepatomegaly
44 (.56%)
Cachexia
43 (.54%)
Osteonecrosis
43 (.54%)
Renal Failure Acute
41 (.52%)
Fatigue
40 (.51%)
Portal Hypertensive Gastropathy
40 (.51%)
Myopathy
39 (.49%)
Hepatic Function Abnormal
38 (.48%)
Hepatic Steatosis
38 (.48%)
Portal Vein Thrombosis
38 (.48%)
Premature Baby
38 (.48%)
Viral Mutation Identified
38 (.48%)
Neuropathy Peripheral
37 (.47%)
Acute Hepatic Failure
36 (.46%)
Gamma-glutamyltransferase Increased
36 (.46%)
Hepatic Fibrosis
36 (.46%)
Liver Disorder
36 (.46%)
Metabolic Acidosis
35 (.44%)
Oesophageal Varices Haemorrhage
35 (.44%)
Blood Amylase Increased
33 (.42%)
Graft Dysfunction
33 (.42%)
Intra-uterine Death
33 (.42%)
Liver Function Test Abnormal
33 (.42%)
Renal Failure
33 (.42%)
Stillbirth
33 (.42%)
Pharyngitis
32 (.41%)
Splenomegaly
32 (.41%)
Diarrhoea
31 (.39%)
Hypertriglyceridaemia
31 (.39%)
Lipase Increased
31 (.39%)
Umbilical Cord Abnormality
31 (.39%)
Dyspnoea
30 (.38%)
General Physical Health Deteriorati...
30 (.38%)
Headache
30 (.38%)
Myalgia
30 (.38%)
Placental Infarction
30 (.38%)
Transplant Rejection
30 (.38%)
Asthenia
29 (.37%)
Blood Creatinine Increased
29 (.37%)
Jaundice
29 (.37%)
Liver Transplant
29 (.37%)
Pneumonia
27 (.34%)
Blood Creatine Phosphokinase Increa...
26 (.33%)
Cytolytic Hepatitis
26 (.33%)
Caesarean Section
25 (.32%)
Encephalopathy
24 (.3%)
Maternal Drugs Affecting Foetus
24 (.3%)
Thrombocytopenia
24 (.3%)
Death
23 (.29%)
Hiv Infection
23 (.29%)
Cd4 Lymphocytes Decreased
22 (.28%)
Disease Recurrence
22 (.28%)
Hypokalaemia
22 (.28%)
Renal Tubular Disorder
22 (.28%)
Sepsis
22 (.28%)
Abdominal Distension
21 (.27%)
Blood Lactic Acid Increased
21 (.27%)
Fanconi Syndrome
21 (.27%)
Hepatic Cirrhosis
21 (.27%)
Hepatic Necrosis
21 (.27%)
Tachypnoea
21 (.27%)
Atrioventricular Block Complete
20 (.25%)
Blood Bilirubin Increased
20 (.25%)
Ophthalmoplegia
20 (.25%)
Anorexia
19 (.24%)

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This graph shows the top adverse events submitted to the FDA for Didanosine, 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 Didanosine 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 Didanosine

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

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This graph shows the top categories of adverse events submitted to the FDA for Didanosine, 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 Didanosine 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 Didanosine According to Those Reporting Adverse Events

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

Hiv Infection
2061
Drug Use For Unknown Indication
121
Antiretroviral Therapy
108
Drug Exposure During Pregnancy
90
Acquired Immunodeficiency Syndrome
58
Hiv Test Positive
30
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Human Immunodeficiency Virus Transm...
26
Retroviral Infection
25
Systemic Antiviral Treatment
23
Prophylaxis
17
Antiviral Prophylaxis
13
Product Used For Unknown Indication
11
Prophylaxis Against Hiv Infection
10
Maternal Exposure During Pregnancy
6
Hiv Infection Cdc Category C3
5
Antiviral Treatment
4
Urticaria
4
Hiv Infection Cdc Category A1
3
Hepatitis C
3
Cd4 Lymphocytes Decreased
3
Vertical Infection Transmission
3
Hepatitis C Virus Test
3
End Stage Aids
2
Unevaluable Event
2
Drug Resistance
2
Ill-defined Disorder
2
Paternal Drugs Affecting Foetus
2
Pneumocystis Jiroveci Infection
2
Adverse Event
2
Maternal Exposure Timing Unspecifie...
2
Pneumocystis Jiroveci Pneumonia
1
Pregnancy
1
Kaposis Sarcoma
1
Pulmonary Tuberculosis
1
Progressive Multifocal Leukoencepha...
1
Hiv Infection Cdc Category A3
1
Anti-infective Therapy
1
Hiv Antibody Positive
1
Infection
1
Hiv Infection Cdc Category B3
1

Drug Labels

LabelLabelerEffective
DidanosineAmerican Health Packaging08-DEC-09
DidanosineAmerican Health Packaging08-DEC-09
DidanosineState of Florida DOH Central Pharmacy11-AUG-10
DidanosineAurobindo Pharma Limited13-JAN-12
DidanosineMylan Pharmaceuticals Inc.24-FEB-12
Videx EcPhysicians Total Care, Inc.01-MAY-12
DidanosinePhysicians Total Care, Inc.02-MAY-12
DidanosineBarr Laboratories Inc.10-AUG-12
DidanosineAurobindo Pharma Limited16-AUG-12
VidexBristol-Myers Squibb Company01-DEC-12
Videx EcBristol-Myers Squibb Company01-DEC-12
DidanosineAurobindo Pharma Limited19-MAR-13

Didanosine Case Reports

What Didanosine 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 Didanosine. 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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