"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
Candin Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Candin (Candida albicans) Skin Test Antigen is a DTH skin test used to evaluate cellular immune response to Candida albicans. Common side effects of Candin include swelling, itching, pain, blistering, and inflammation at the site of the skin test.
The recommended dose of Candin is 0.1 mL. Candin must be administered under a doctor's supervision. Corticosteroids may interact with Candin. Tell your doctor all medications you take. Caution should be taken not to inject Candin into a blood vessel. If you are pregnant only take Candin if clearly needed. Caution should be exercised if you take Candin while breastfeeding.
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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Candin FDA Prescribing Information: Side Effects
Local reactions to CANDIN® (candida albicans) have included swelling, pruritus and vesiculation. Reactions involving necrosis and ulceration have not been observed, but such reactions are theoretically possible and might occur in persons with exquisite cellular hypersensitivity to the antigen. Local reactions may be treated with a cold compress and topical steroids. Severe local reactions may require additional measures as appropriate.
In a published study (13) of 479 HIV positive adults tested with CANDIN® (candida albicans) , adverse local reactions were observed in six subjects as follows: pruritus (three), swelling at the test site (one), vesiculation (one) and vesiculation with weeping edema (one). Pruritus and swelling cleared within 48 hours; vesiculation with edema required approximately 1 wee k to resolve (15).
In two studies involving 171 persons discussed under CLINICAL PHARMACOLOGY in Tables 1, 2, 3, and text, one adverse reaction was observed. This reaction consisted of induration 22 x 55 mm at 48 hours which resolved within 1 week (15).
Testing of CANDIN® (candida albicans) for consistency of potency is performed in healthy human subjects who are known to be skin-test positive to the antigen. In 58 subjects tested to-date, there have been no cases of Type 1 allergy manifested as either generalized or adverse local reactions. One subject had induration with a central vesicle which subsided within a few da ys (15).
Severe local reactions, including rash, vesiculation, bullae, dermal exfoliation and cellulitis, have been reported to MedWatch for unstandardized allergenic extracts of Candida albicans used for anergy testing (17).
Systemic reactions to CANDIN® (candida albicans) have not been observed. However, all foreign antigens have the remote possibility of causing Type 1 anaphylaxis (14) and even death when injected intradermally. Systemic reactions usually occur within 30 minutes after the injection o f antigen and may include the following symptoms: sneezing, coughing, itching, shortness of breath, abdominal cramps , vomiting, diarrhea, tachycardia, hypotension and respiratory failure in severe cases. Systemic allergic reactions including anaphylaxis must be immediately treated with Epinephrine HCL 1:1,000. Additional measures may be required, depending upon the severity of the reaction.
Immediate Hypersensitivity reactions to CANDIN® (candida albicans) occur in some individuals. These reactions are characterized by the presence of an edematous hive surrounded by a zone of erythema. They occur approximately 15 - 20 minutes after the intradermal injection of the antigen. The size of the immediate reaction varies depending upon the sensitivity of the individual. Immediate hypersensitivity reactions were observed in the control and HIV-infected (AIDS and HIV positive) subjects reported in Table 2 as follows: HIV-infected subjects (20% with erythema of 10 - 21 mm in diameter; 13% with erythema of 5 - 9 mm). Control subjects (22% with erythema of 10 - 15 mm; 5% with erythema of 8.5 mm). Cancer subjects (Group 1, Table 3), 17% with erythema of 10 - 24 mm and 11% with erythema of 6 - 9 mm.
Read the entire FDA prescribing information for Candin (Candida Albicans)
Additional Candin 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.
Find out what women really need.