Ablavar
Ablavar Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Ablavar in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- urinating less than usual or not at all;
- drowsiness, confusion, mood changes, increased thirst, loss of appetite;
- swelling, weight gain, feeling short of breath; or
- fast, uneven heart rate.
Less serious side effects may include:
- mild itching;
- headache, dizziness;
- nausea, unusual or unpleasant taste in your mouth;
- warmth, redness, burning, or tingly feeling under your skin;
- cold feeling, warmth, pain, bruising, or burning where the injection was given; or
- numbness or tingling in your hands or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Ablavar (Gadofosveset Trisodium Injection) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ablavar FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
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].
In all clinical trials evaluating ABLAVAR (gadofosveset trisodium injection) with MRA, a total of 1,676 (1379 patients and 297 healthy subjects) were exposed to various doses ABLAVAR (gadofosveset trisodium injection) . The mean age of the 1379 patients who received ABLAVAR (gadofosveset trisodium injection) 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 (gadofosveset trisodium injection) at a dose of 0.03 mmol/kg.
Table 2 : Common Adverse Reactions in 802 Subjects Receiving
ABLAVAR (gadofosveset trisodium injection) 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.
Read the entire FDA prescribing information for Ablavar (Gadofosveset Trisodium Injection) »
Additional Ablavar Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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