INGENOL MEBUTATE for Hyperkeratosis: Side Effects & Safety Data
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There are 16 adverse event reports in the FDA FAERS database where INGENOL MEBUTATE was used for Hyperkeratosis.
Most Reported Side Effects for INGENOL MEBUTATE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Application site erythema | 1,373 | 45.4% | 0 | 12 |
| Application site pain | 1,012 | 33.5% | 0 | 13 |
| Application site vesicles | 843 | 27.9% | 0 | 4 |
| Application site exfoliation | 586 | 19.4% | 0 | 4 |
| Drug administered at inappropriate site | 500 | 16.5% | 0 | 7 |
| Application site swelling | 489 | 16.2% | 0 | 7 |
| Application site scab | 451 | 14.9% | 0 | 5 |
| Application site dryness | 365 | 12.1% | 0 | 0 |
| Incorrect drug administration duration | 339 | 11.2% | 0 | 9 |
| Application site pruritus | 291 | 9.6% | 0 | 2 |
| Inappropriate schedule of drug administration | 250 | 8.3% | 0 | 3 |
| Drug administration error | 214 | 7.1% | 0 | 3 |
| Incorrect dose administered | 214 | 7.1% | 0 | 1 |
| Eye swelling | 198 | 6.6% | 1 | 7 |
| Application site discharge | 188 | 6.2% | 0 | 0 |
Other Indications for INGENOL MEBUTATE
Actinic keratosis (1,751)
Product used for unknown indication (582)
Precancerous skin lesion (416)
Solar lentigo (77)
Actinic cheilitis (43)
Skin cancer (38)
Squamous cell carcinoma (19)
Basal cell carcinoma (18)
Precancerous cells present (12)
Skin discolouration (10)
Other Drugs Used for Hyperkeratosis
SALICYLIC ACID (151)
FLUOROURACIL (52)
SCHOLLS CORN REMOVERS (32)
SCHOLL'S ONE STEP CORN REMOVERS (21)
IMIQUIMOD (17)
SCHOLLS CALLUS REMOVERS (11)
SCHOLLS EXTRA THICK CALLUS REMOVERS (10)
SCHOLL'S LIQUID CORN/CALLUS REMOVER (9)
DUPILUMAB (8)
SCHOLL'S CALLUS REMOVERS (8)