Sotradecol
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Sotradecol
Sotradecol 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.
Sotradecol in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; sneezing, runny nose, difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- pain or swelling in one or both legs;
- chest pain, sudden cough, wheezing, rapid breathing, fast heart rate; or
- pain, itching, peeling, skin sores, or skin changes where the medicine was injected.
Less serious side effects may include:
- mild headache;
- nausea, vomiting; or
- discolored skin along the treated vein (may be permanent).
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 Sotradecol (Sodium Tetradecyl) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Sotradecol FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Local reactions consisting of pain, urticaria or ulceration may occur at the site of injection. A permanent discoloration may remain along the path of the sclerosed vein segment. Sloughing and necrosis of tissue may occur following extravasation of the drug. (See WARNINGS section).
Allergic reactions such as hives, asthma, hay fever and anaphylactic shock have been reported. Mild systemic reactions that have been reported include headache, nausea and vomiting. (See WARNINGS section).
At least six deaths have been reported with the use of Sotradecol® (sodium tetradecyl) . Four cases of anaphylactic shock leading to death have been reported in patients who received Sotradecol® (sodium tetradecyl) . One of these four patients reported a history of asthma, a contraindication to the administration of Sotradecol®. (See WARNINGS section).
One death has been reported in a patient who received Sotradecol® (sodium tetradecyl) and who had been receiving an an ovulatory agent. Another death (fatal pulmonary embolism) has been reported in a 36-year-old female treated with sodium tetradecyl acetate and who was not taking oral contraceptives.
Read the entire FDA prescribing information for Sotradecol (Sodium Tetradecyl) »
Additional Sotradecol 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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