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Ablavar (Gadofosveset Trisodium) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience

Anaphylaxis and anaphylactoid reactions were the most common serious reactions observed following Ablavar injection administration [ see Warnings and Precautions (5.2) ].

In all clinical trials evaluating Ablavar with MRA, a total of 1,676 (1379 patients and 297 healthy subjects) were exposed to various doses Ablavar. The mean age of the 1379 patients who received Ablavar was 63 years (range 18 to 91 years); 66% (903) were men and 34% (476) were women. In this population, there were 80% (1100) Caucasian, 8% (107) Black, 12% (159) Hispanic, 1% (7) Asian, and < 1% (6) patients of other racial or ethnic groups. Table 2 shows the most common adverse reactions (≥1%) experienced by subjects receiving Ablavar at a dose of 0.03 mmol/kg.

Table 2 Common Adverse Reactions in 802 Subjects Receiving Ablavar at 0.03 mmol/kg
Preferred Term n (%)
Pruritis 42 (5)
Headache 33 (4)
Nausea 33 (4)
Vasodilatation 26 (3)
Paresthesia 25 (3)
Injection site bruising 19 (2)
Dysgeusia 18 (2)
Burning sensation 17 (2)
Venipuncture site bruise 17 (2)
Hypertension 11 (1)
Dizziness (excluding vertigo) 8 (1)
Feeling cold 7 (1)

Post-marketing Experience

Because post-marketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The profile of adverse reactions identified during the post-marketing experience outside the United States was similar to that observed during the clinical studies experience.



REPORTS OF SUSPECTED ABLAVAR SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Ablavar. The information is not vetted and should not be considered as verified clinical evidence.

Possible Ablavar side effects / adverse reactions in 26 year old female

Reported by a physician from United States on 2011-12-16

Patient: 26 year old female weighing 52.7 kg (116.0 pounds)

Reactions: Vomiting, Syncope, Nausea

Suspect drug(s):
Dilaudid
    Dosage: (2 dosage forms),intravenous
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-22
    End date: 2011-11-22

Ablavar
    Dosage: via power injector (7 ml),intravenous
    Indication: Renal Aneurysm
    Start date: 2011-11-22
    End date: 2011-11-22

Ablavar
    Dosage: via power injector (7 ml),intravenous
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2011-11-22
    End date: 2011-11-22



See index of all Ablavar side effect reports >>

Drug label data at the top of this Page last updated: 2010-07-01

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