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Ultiva Adverse Events Reported to the FDA Over Time

How are Ultiva adverse event reports trending over time?

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

Most Common Ultiva Adverse Events Reported to the FDA

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

Hypotension
58 (2.22%)
Anaphylactic Shock
49 (1.88%)
Cardiac Arrest
48 (1.84%)
Apnoea
40 (1.53%)
Drug Interaction
38 (1.46%)
Bradycardia
37 (1.42%)
Drug Rash With Eosinophilia And Sys...
37 (1.42%)
Hypoxia
35 (1.34%)
Renal Failure Acute
34 (1.3%)
Delayed Recovery From Anaesthesia
30 (1.15%)
Circulatory Collapse
29 (1.11%)
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Blood Pressure Decreased
28 (1.07%)
Bronchospasm
27 (1.04%)
Respiratory Depression
27 (1.04%)
Generalised Erythema
24 (.92%)
Oliguria
24 (.92%)
Serotonin Syndrome
24 (.92%)
Agitation
23 (.88%)
Lymphopenia
23 (.88%)
Tachycardia
23 (.88%)
Drug Exposure During Pregnancy
22 (.84%)
Anaphylactic Reaction
21 (.81%)
Vomiting
21 (.81%)
Mydriasis
20 (.77%)
Haematuria
19 (.73%)
Hypertension
19 (.73%)
Myoclonus
19 (.73%)
Oxygen Saturation Decreased
19 (.73%)
Heart Rate Increased
18 (.69%)
Stress Cardiomyopathy
18 (.69%)
Blood Pressure Increased
17 (.65%)
Coma
17 (.65%)
Hyperreflexia
17 (.65%)
Pulmonary Oedema
17 (.65%)
Premature Baby
16 (.61%)
Pupillary Reflex Impaired
16 (.61%)
Restlessness
16 (.61%)
Staring
16 (.61%)
Erythema
15 (.58%)
Rash
15 (.58%)
Respiratory Arrest
15 (.58%)
Blood Phosphorus Increased
14 (.54%)
Heart Rate Decreased
14 (.54%)
Speech Disorder
14 (.54%)
Anaesthetic Complication
13 (.5%)
Hyperthermia Malignant
13 (.5%)
Post Procedural Complication
13 (.5%)
Urticaria
13 (.5%)
Akathisia
12 (.46%)
Alanine Aminotransferase Increased
12 (.46%)
Caesarean Section
12 (.46%)
Cerebral Haematoma
12 (.46%)
Muscle Rigidity
12 (.46%)
Sedation
12 (.46%)
Shock
12 (.46%)
Arteriospasm Coronary
11 (.42%)
Blood Calcium Increased
11 (.42%)
Drug Toxicity
11 (.42%)
Electrocardiogram St Segment Elevat...
11 (.42%)
Stevens-johnson Syndrome
11 (.42%)
White Blood Cell Count Increased
11 (.42%)
Blood Creatinine Increased
10 (.38%)
C-reactive Protein Increased
10 (.38%)
Convulsion
10 (.38%)
Drug Ineffective
10 (.38%)
Electrocardiogram St Segment Depres...
10 (.38%)
Extensor Plantar Response
10 (.38%)
Loss Of Consciousness
10 (.38%)
Off Label Use
10 (.38%)
Overdose
10 (.38%)
Anaphylactoid Shock
9 (.35%)
Cerebral Haemorrhage
9 (.35%)
Chills
9 (.35%)
Cyanosis
9 (.35%)
Drug Withdrawal Syndrome
9 (.35%)
Glasgow Coma Scale Abnormal
9 (.35%)
Procedural Complication
9 (.35%)
Respiratory Acidosis
9 (.35%)
Rhabdomyolysis
9 (.35%)
Aspartate Aminotransferase Increase...
8 (.31%)
Blood Alkaline Phosphatase Increase...
8 (.31%)
Diarrhoea
8 (.31%)
Drug Withdrawal Syndrome Neonatal
8 (.31%)
Feeding Disorder
8 (.31%)
Hyperaesthesia
8 (.31%)
Irritability
8 (.31%)
Maternal Drugs Affecting Foetus
8 (.31%)
Po2 Decreased
8 (.31%)
Premature Labour
8 (.31%)
Product Quality Issue
8 (.31%)
Thrombocytopenia
8 (.31%)
Torsade De Pointes
8 (.31%)
Transient Tachypnoea Of The Newborn
8 (.31%)
Ventricular Fibrillation
8 (.31%)
Ventricular Tachycardia
8 (.31%)
Vocal Cord Disorder
8 (.31%)
Abdominal Pain
7 (.27%)
Altered State Of Consciousness
7 (.27%)
Drug Prescribing Error
7 (.27%)
Electromechanical Dissociation
7 (.27%)
Eye Movement Disorder
7 (.27%)

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

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

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

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

Anaesthesia
203
General Anaesthesia
142
Maintenance Of Anaesthesia
128
Induction Of Anaesthesia
92
Induction And Maintenance Of Anaest...
50
Analgesic Therapy
50
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Drug Use For Unknown Indication
49
Product Used For Unknown Indication
47
Sedation
36
Anaesthesia Procedure
21
Analgesic Effect
16
Pain
11
Stupor
9
Analgesia
9
Ill-defined Disorder
8
Foetal Exposure During Pregnancy
8
Drug Exposure During Pregnancy
7
Sedative Therapy
7
Prophylaxis
6
Surgery
4
Postoperative Analgesia
4
Cerebral Disorder
4
Accidental Overdose
4
Rhinoplasty
3
Head And Neck Cancer
2
Off Label Use
2
Maternal Drugs Affecting Foetus
2
Nephroureterectomy
2
Neuromuscular Blockade
2
Intubation
2
Vascular Operation
2
Maternal Exposure During Pregnancy
2
Sensory Disturbance
2
Nasal Septal Operation
2
Agitation
2
Thyroglossal Cyst Excision
1
Phlebectomy
1
Parotid Cyst Excision
1
Pathological Fracture
1
Nerve Block
1
Drug Abuse
1
Intraoperative Care
1
Drug Toxicity
1
Pneumonia Fungal
1
Intentional Drug Misuse
1
Labour Pain
1
Overdose
1
Glaucoma Surgery
1
Maternal Exposure Timing Unspecifie...
1
Female Genital Operation
1
Pain Management
1

Drug Labels

LabelLabelerEffective
UltivaMylan Institutional LLC20-JUL-11

Ultiva Case Reports

What Ultiva 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 Ultiva. 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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