warnings
WARNINGS Discontinue use if hypersensitivity occurs.
FDA label 69e4bafb-01ba-41e1-88cd-a3fb6494ef14
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
- SPL set ID
- 48cf9e89-d84d-f94d-93fe-e720b4486ad3
- SPL ID
- 69e4bafb-01ba-41e1-88cd-a3fb6494ef14
- Version
- 6
- Effective date
- 2012-06-06
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:32:16
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 69e4bafb-01ba-41e1-88cd-a3fb6494ef14 | id | |
| spl set id | 48cf9e89-d84d-f94d-93fe-e720b4486ad3 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Adverse events reported for most body systems occurred at similar frequencies in VANIQA (eflornithine hydrochloride) Cream, 13.9% and vehicle-control groups, The most frequent adverse events related to treatment with VANIQA were skin-related, The following table notes the percentage of adverse events associated with the use of VANIQA or its vehicle that occurred at greater than 1% in both the vehicle controlled studies and the open-label safety studies up to 1 year of continuous use. Adverse Event Term Vehicle-Controlled Studies Vehicle-Controlled and Open-Label Studies VANIQA (n=393) Vehicle (n=201) VANIQA (n=1373) Acne 21.3 21.4 10,8 Pseudofolliculitis Barbae 16.3 15.4 4.9 Stinging Skin 7.9 2.5 4.1 Headache 3.8 5.0 4.0 Burning Skin 4.3 2.0 3.5 Dry Skin 1.8 3.0 3.3 Pruritus (itching) 3.8 4.0 3.1 Erythema (redness) 1.3 0.0 2.5 Tingling Skin 3.6 1.5 2.2 Dyspepsia 2.5 2.0 1.9 Skin Irritation 1.0 1.0 1.8 Rash 2.8 0.0 1.5 Alopecia 1.5 2.5 1.3 Dizziness 1.5 1.5 1.3 Folliculitis 0.5 0.0 1.0 Hair Ingrown 0.3 2.0 0.9 Facial Edema 0.3 3.0 0.7 Anorexia 1.0 2.0 0.7 Nausea 0.5 1.0 0.7 Asthenia 0.0 1.0 0.3 Vertigo 0.3 1.0 0.1 Treatment-related skin adverse events that occurred in less than 1% of the subjects treated with VANIQA are: bleeding skin, cheililis, contact dermatitis, swelling of lips, herpes simplex, numbness and rosacea. Adverse events were primarily mild in intensity and generally resolved without medical treatment or discontinuation of VANIQA. Only 2% of subjects discontinued studies due to an adverse event related to use of VANIQA. Laboratory Test Abnormalities No laboratory test abnormalities have been consistently found to be associated with VANIQA. In an open-label study, some patients showed an increase in their transaminases; however, the clinical significance of these findings is not known.
adverse reactions table
<table border="1" cellpadding="0" width="60%"> <colgroup> <col/> <col align="center" width="20%"/> <col align="center" width="20%"/> <col align="center" width="20%"/> </colgroup> <tbody> <tr> <td align="center" rowspan="2" styleCode="Botrule Lrule Rrule Toprule" valign="bottom"> <paragraph> <content styleCode="bold">Adverse Event Term</content> </paragraph> <paragraph> </paragraph> </td> <td align="center" colspan="2" styleCode="Botrule Lrule Rrule Toprule" valign="bottom"> <paragraph> <content styleCode="bold">Vehicle-Controlled Studies</content> </paragraph> <paragraph> </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="bottom"> <paragraph> <content styleCode="bold">Vehicle-Controlled and Open-Label Studies</content> </paragraph> </td> </tr> <tr> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph> <content styleCode="italics">VANIQA</content> </paragraph> <paragraph> <content styleCode="italics">(n=393)</content> </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph> <content styleCode="italics">Vehicle</content> </paragraph> <paragraph> <content styleCode="italics">(n=201)</content> </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph> <content styleCode="italics">VANIQA</content> </paragraph> <paragraph> <content styleCode="italics">(n=1373)</content> </paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Acne</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>21.3</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>21.4</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>10,8</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Pseudofolliculitis Barbae</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>16.3</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>15.4</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>4.9</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Stinging Skin </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>7.9</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>2.5</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>4.1</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Headache </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>3.8</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>5.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>4.0</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Burning Skin </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>4.3</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>2.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>3.5</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Dry Skin</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.8</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>3.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>3.3</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Pruritus (itching)</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>3.8</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>4.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>3.1</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Erythema (redness) </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.3</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>2.5</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Tingling Skin </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>3.6</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.5</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>2.2</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Dyspepsia </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>2.5</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>2.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.9</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Skin Irritation </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.8</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Rash </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>2.8</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.5</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Alopecia </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.5</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>2.5</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.3</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Dizziness </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.5</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.5</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.3</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Folliculitis </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.5</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.0</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Hair Ingrown </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.3</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>2.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.9</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Facial Edema </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.3</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>3.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.7</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Anorexia </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>2.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.7</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Nausea </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.5</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.7</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Asthenia </paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.3</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>Vertigo</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.3</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>1.0</paragraph> </td> <td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"> <paragraph>0.1</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.