FDA label 60a460f5-0755-78a5-e053-2a91aa0af235

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
b8fadaec-9985-4f17-9b2f-b2f6a28cae1c
SPL ID
60a460f5-0755-78a5-e053-2a91aa0af235
Version
2
Effective date
2017-12-18
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:13:34

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS PERSONS WHO ARE ON DRUGS WHICH SUPPRESS THE IMMUNE SYSTEM ARE MORE SUSCEPTIBLE TO INFECTIONS THAN HEALTHY INDIVIDUALS. CHICKENPOX AND MEASLES, FOR EXAMPLE, CAN HAVE A MORE SERIOUS OR EVEN FATAL COURSE IN NON-IMMUNE CHILDREN OR ADULTS ON CORTICOSTEROIDS. iN SUCH CHILDREN OR ADULTS WHO HAVE NOT HAD THESE DISEASES, PARTICULAR CARE SHOULD BE TAKEN TO AVOID EXPOSURE. HOW THE DOSE, ROUTE AND DURATION OF CORTICOSTEROID ADMINISTRATION AFFECTS THE RISK OF DEVELOPING A DISSEMINATED INFECTION IS NOT KNOWN. THE CONTRIBUTION OF THE UNDERLYING DISEASE AND/OR PRIOR CORTICOSTEROID TREATMENT TO THE RISK IS ALSO NOT KNOWN. IF EXPOSED TO THE CHICKEN POX, PROPHYLAXIS WITH VARICELLA ZOSTER IMMUNE GLOBULIN (VZIG) MAY BE INDICATED. IF EXPOSED TO MEASLES, PROPHYLAXIS WITH POOLED INTRAMUSCULAR IMMUNOGLOBULIN (IG) MAY BE INDICATED. (SEE THE RESPECTIVE PACKAGE INSERTS FOR COMPLETE VZIG AND IG PRESCRIBING INFORMATION.) IF CHICKENPOX DEVELOPS, TREATMENT WITH ANTIVIRAL AGENTS MAY BE CONSIDERED. IN PATIENTS ON CORTICOSTEROID THERAPY SUBJECTED TO UNUSUAL STRESS INCREASED DOSAGE OF RAPIDLY ACTING CORTICOSTEROIDS BEFORE, DURING, AND AFTER THE STRESSFUL SITUATION IS INDICATED. CORTICOSTEROIDS MAY MASK SOME SIGNS OF INFECTION, AND NEW INFECTIONS MAY APPEAR DURING THEIR USE. THERE MAY BE DECREASED RESISTANCE AND INABILITY TO LOCALIZE INFECTION WHEN CORTICOSTEROIDS ARE USED. PROLONGED USE OF CORTICOSTEROIDS MAY PRODUCE POSTERIOR SUBCAPSULAR CATARACTS, GLAUCOMA WITH POSSIBLE DAMAGE TO THE OPTIC NERVES, AND MAY ENHANCE THE ESTABLISHMENT OF SECONDARY OCULAR INFECTIONS DUE TO FUNGI OR VIRUSES.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS FLUID AND ELECTROLYTE DISTURBANCES SODIUM RETENTION. FLUID RETENTION. CONGESTIVE HEART FAILURE IN SUSCEPTIBLE PATIENTS. POTASSIUM LOSS. HYPOKALEMIC ALKALOSIS. HYPERTENSION. MUSCULOSKELETAL MUSCLE WEAKNESS. STEROID MYOPATHY. LOSS OF MUSCLE MASS. OSTEOPOROSIS. VERTEBRAL COMPRESSION FRACTURES. ASEPTIC NECROSIS OF FEMORAL AND HUMERAL HEADS. PATHOLOGIC FRACTURE OF LONG BONES. GASTROINTESTINAL PEPTIC ULCER WITH POSSIBLE PERFORATION AND HEMORRHAGE. PANCREATITIS. ABDOMINAL DISTENTION. ULCERATIVE ESOPHAGITIS. DERMATOLOGIC IMPAIRED WOUND HEALING. THIN FRAGILE SKIN. PETECHIAE AND SCCHYMOSES. FACIAL ERYTHEMA. INCREASED SWEATING. MAY SUPRESS REACTIONS TO SKIN TESTS. NEUROLOGICAL CONVULSIONS. INCREASED INTERCRANIAL PRESSURE WITH PAPILLEDEMA (PSEUDOTUMOR CEREBRI) USUALLY AFTER TREATMENT. VERTIGO. HEADACHE. ENDOCRINE MENSTRUAL IRREGULARITIES. DEVELOPMENT OF CUSHINGOID STATE. SUPPRESSION OF GROWTH IN CHILDREN. SECONDARY ADRENOCORTICAL AND PITUITARY UNRESPONSIVENESS, PARTICULARLY IN TIMES OF STRESS, AS IN TRAUMA, SURGERY, OR ILLNESS. DECREASED CARBOHYDRATE TOLERANCE. MANIFESTATIONS OF LATENT DIABETES MELITUS. INCREASED REQUIREMENTS FOR INSULIN OR ORAL HYPOGLYCEMIC AGENTS IN DIABETES. OPHTHALMIC POSTERIOR SUBCAPSULAR CATARACTS. INCREASED INTRAOCULAR PRESSURE. GLAUCOMA. EXOPHTHALMOS. METABOLIC NEGATIVE NITROGEN BALANCE DUE TO PROTEIN CATABOLISM.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.