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FDA label eef3b028-5260-4be4-89c7-c47bad4f3592

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SPL set ID
d8b4ec77-5f93-4a4f-9a4c-ee0767ac6ac5
SPL ID
eef3b028-5260-4be4-89c7-c47bad4f3592
Version
9
Effective date
2010-08-01
Source export date
2026-10-12
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/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:04:04

Boxed warning cross-check#

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boxed warning

WARNING Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream. Therefore: Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. ELIDEL Cream is not indicated for use in children less than 2 years of age.

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warnings

WARNINGS WARNING Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream. Therefore: Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. ELIDEL Cream is not indicated for use in children less than 2 years of age. Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression. Based on this information and the mechanism of action, there is a concern about a potential risk with the use of topical calcineurin inhibitors, including ELIDEL Cream. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream. Therefore: ELIDEL Cream should not be used in immunocompromised adults and children. If signs and symptoms of atopic dermatitis do not improve within 6 weeks, patients should be re-examined by their healthcare provider and their diagnosis be confirmed (see PRECAUTIONS). The safety of ELIDEL Cream has not been established beyond one year of non-continuous use. (See CLINICAL PHARMACOLOGY, WARNINGS, boxed WARNING, PRECAUTIONS, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION. )

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adverse reactions

ADVERSE REACTIONS No phototoxicity and no photoallergenicity were detected in clinical studies with 24 and 33 normal volunteers, respectively. In human dermal safety studies, ELIDEL ® (pimecrolimus) Cream 1% did not induce contact sensitization or cumulative irritation. In a one-year safety study in pediatric patients age 2-17 years old involving sequential use of ELIDEL Cream and a topical corticosteroid, 43% of ELIDEL patients and 68% of vehicle patients used corticosteroids during the study. Corticosteroids were used for more than 7 days by 34% of ELIDEL patients and 54% of vehicle patients. An increased incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis, and urticaria were found in the patients that had used ELIDEL Cream and topical corticosteroid sequentially as compared to ELIDEL Cream alone. In 3 randomized, double-blind vehicle-controlled pediatric studies and one active-controlled adult study, 843 and 328 patients respectively, were treated with ELIDEL Cream. In these clinical trials, 48 (4%) of the 1,171 ELIDEL patients and 13 (3%) of 408 vehicle-treated patients discontinued therapy due to adverse events. Discontinuations for AEs were primarily due to application site reactions, and cutaneous infections. The most common application site reaction was application site burning, which occurred in 8%-26% of patients treated with ELIDEL Cream. The following table depicts the incidence of adverse events pooled across the 2 identically designed 6-week studies with their open label extensions and the 1-year safety study for pediatric patients ages 2-17. Data from the adult active-controlled study is also included in this table. Adverse events are listed regardless of relationship to study drug. Treatment Emergent Adverse Events ( ≥1%) in Elidel ® Treatment Groups Pediatric P atients* Vehicle-Controlled (6 weeks) Pediatric Patients* Open-Label (20 weeks) Pediatric Patients* Vehicle-Controlled (1 year) Adult A ctive Comparator (1 year) Elidel ® Cream (N=267) N (%) Vehicle (N=136) N (%) Elidel ® Cream (N=335) N (%) Elidel ® Cream (N=272) N (%) Vehicle (N=75) N (%) Elidel ® Cream (N=328) N (%) At least 1 AE 182 (68.2%) 97 (71.3%) 240 (72.0%) 230 (84.6%) 56 (74.7%) 256 (78.0%) Infections and Infestations Upper Respiratory Tract Infection NOS 38 (14.2%) 18 (13.2%) 65 (19.4%) 13 (4.8%) 6 (8.0%) 14 (4.3%) Nasopharyngitis 27 (10.1%) 10 (7.4%) 32 (19.6%) 72 (26.5%) 16 (21.3%) 25 (7.6%) Skin Infection NOS 8 (3.0%) 9 (5.1%) 18 (5.4%) 6 (2.2%) 3 (4.0%) 21 (6.4%) Influenza 8 (3.0%) 1 (0.7%) 22 (6.6%) 36 (13.2%) 3 (4.0%) 32 (9.8%) Ear Infection NOS 6 (2.2%) 2 (1.5%) 19 (5.7%) 9 (3.3%) 1 (1.3%) 2 (0.6%) Otitis Media 6 (2.2%) 1 (0.7%) 10 (3.0%) 8 (2.9%) 4 (5.3%) 2 (0.6%) Impetigo 5 (1.9%) 3 (2.2%) 12 (3.6%) 11 (4.0%) 4 (5.3%) 8 (2.4%) Bacterial Infection 4 (1.5%) 3 (2.2%) 4 (1.2%) 3 (1.1%) 0 6 (1.8%) Folliculitis 3 (1.1%) 1 (0.7%) 3 (0.9%) 6 (2.2%) 3 (4.0%) 20 (6.1%) Sinusitis 3 (1.1%) 1 (0.7%) 11 (3.3%) 6 (2.2%) 1 (1.3%) 2 (0.6%) Pneumonia NOS 3 (1.1%) 1 (0.7%) 5 (1.5%) 0 1 (1.3%) 1 (0.3%) Pharyngitis NOS 2 (0.7%) 2 (1.5%) 3 (0.9%) 22 (8.1%) 2 (2.7%) 3 (0.9%) Pharyngitis Streptococcal 2 (0.7%) 2 (1.5%) 10 (3.0%) 0 <1% 0 Molluscum Contagiosum 2 (0.7%) 0 4 (1.2%) 5 (1.8%) 0 0 Staphylococcal Infection 1 (0.4%) 5 (3.7%) 7 (2.1%) 0 <1% 3 (0.9%) Bronchitis NOS 1 (0.4%) 3 (2.2%) 4 (1.2%) 29 (10.7%) 6 (8.0%) 8 (2.4%) Herpes Simplex 1 (0.4%) 0 4 (1.2%) 9 (3.3%) 2 (2.7%) 13 (4.0%) Tonsillitis NOS 1 (0.4%) 0 3 (0.9%) 17 (6.3%) 0 2 (0.6%) Viral Infection NOS 2 (0.7%) 1 (0.7%) 1 (0.3%) 18 (6.6%) 1 (1.3%) 0 Gastroenteritis NOS 0 3 (2.2%) 2 (0.6%) 20 (7.4%) 2 (2.7%) 6 (1.8%) Chickenpox 2 (0.7%) 0 3 (0.9%) 8 (2.9%) 3 (4.0%) 1 (0.3%) Skin Papilloma 1 (0.4%) 0 2 (0.6%) 9 (3.3%) <1% 0 Tonsillitis Acute NOS 0 0 0 7 (2.6%) 0 0 Upper Respiratory Tract Infection Viral NOS 1 (0.4%) 0 3 (0.9%) 4 (1.5%) 0 1 (0.3%) Herpes Simplex Dermatitis 0 0 1 (0.3%) 4 (1.5%) 0 2 (0.6%) Bronchitis Acute NOS 0 0 0 4 (1.5%) 0 0 Eye Infection NOS 0 0 0 3 (1.1%) <1% 1 (0.3%) General Disorders and Administration Site Conditions Application Site Burning 28 (10.4%) 17 (12.5%) 5 (1.5%) 23 (8.5%) 5 (6.7%) 85 (25.9%) Pyrexia 20 (7.5%) 12 (8.8%) 41 (12.2%) 34 (12.5%) 4 (5.3%) 4 (1.2%) Application Site Reaction NOS 8 (3.0%) 7 (5.1%) 7 (2.1%) 9 (3.3%) 2 (2.7%) 48 (14.6%) Application Site Irritation 8 (3.0%) 8 (5.9%) 3 (0.9%) 1 (0.4%) 3 (4.0%) 21 (6.4%) Influenza Like Illness 1 (0.4%) 0 2 (0.6%) 5 (1.8%) 2 (2.7%) 6 (1.8%) Application Site Erythema 1 (0.4%) 0 0 6 (2.2%) 0 7 (2.1%) Application Site Pruritus 3 (1.1%) 2 (1.5%) 2 (0.6%) 5 (1.8%) 0 18 (5.5%) Respiratory, Thoracic and Mediastinal Disorders Cough 31 (11.6%) 11 (8.1%) 31 (9.3%) 43 (15.8%) 8 (10.7%) 8 (2.4%) Nasal Congestion 7 (2.6%) 2 (1.5%) 6 (1.8%) 4 (1.5%) 1 (1.3%) 2 (0.6%) Rhinorrhea 5 (1.9%) 1 (0.7%) 3 (0.9%) 1 (0.4%) 1 (1.3%) 0 Asthma Aggravated 4 (1.5%) 3 (2.2%) 13 (3.9%) 3 (1.1%) 1 (1.3%) 0 Sinus Congestion 3 (1.1%) 1 (0.7%) 2 (0.6%) <1% <1% 3 (0.9%) Rhinitis 1 (0.4%) 0 5 (1.5%) 12 (4.4%) 5 (6.7%) 7 (2.1%) Wheezing 1 (0.4%) 1 (0.7%) 4 (1.2%) 2 (0.7%) <1% 0 Asthma NOS 2 (0.7%) 1 (0.7%) 11 (3.3%) 10 (3.7%) 2 (2.7%) 8 (2.4%) Epistaxis 0 1 (0.7%) 0 9 (3.3%) 1 (1.3%) 1 (0.3%) Dyspnea NOS 0 0 0 5 (1.8%) 1 (1.3%) 2 (0.6%) Gastrointestinal Disorders Abdominal Pain Upper 11 (4.1%) 6 (4.4%) 10 (3.0%) 15 (5.5%) 5 (6.7%) 1 (0.3%) Sore Throat 9 (3.4%) 5 (3.7%) 15 (5.4%) 22 (8.1%) 4 (5.3%) 12 (3.7%) Vomiting NOS 8 (3.0%) 6 (4.4%) 14 (4.2%) 18 (6.6%) 6 (8.0%) 2 (0.6%) Diarrhea NOS 3 (1.1%) 1 (0.7%) 2 (0.6%) 21 (7.7%) 4 (5.3%) 7 (2.1%) Nausea 1 (0.4%) 3 (2.2%) 4 (1.2%) 11 (4.0%) 5 (6.7%) 6 (1.8%) Abdominal Pain NOS 1 (0.4%) 1 (0.7%) 5 (1.5%) 12 (4.4%) 3 (4.0%) 1 (0.3%) Toothache 1 (0.4%) 1 (0.7%) 2 (0.6%) 7 (2.6%) 1 (1.3%) 2 (0.6%) Constipation 1 (0.4%) 0 2 (0.6%) 10 (3.7%) <1% 0 Loose Stools 0 1 (0.7%) 4 (1.2%) <1% <1% 0 Reproductive System and Breast Disorders Dysmenorrhea 3 (1.1%) 0 5 (1.5%) 3 (1.1%) 1 (1.3%) 4 (1.2%) Eye Disorders Conjunctivitis NEC 2 (0.7%) 1 (0.7%) 7 (2.1%) 6 (2.2%) 3 (4.0%) 10 (3.0%) Skin & Subcutaneous Tissue Disorders Urticaria 3 (1.1%) 0 1 (0.3%) 1 (0.4%) <1% 3 (0.9%) Acne NOS 0 1 (0.7%) 1 (0.3%) 4 (1.5%) <1% 6 (1.8%) Immune System Disorders Hypersensitivity NOS 11 (4.1%) 6 (4.4%) 16 (4.8%) 14 (5.1%) 1 (1.3%) 11 (3.4%) Injury and Poisoning Accident NOS 3 (1.1%) 1 (0.7%) 1 (0.3%) <1% 1 (1.3%) 0 Laceration 2 (0.7%) 1 (0.7%) 5 (1.5%) <1% <1% 0 Musculoskeletal, Connective Tissue and Bone Disorders Back Pain 1 (0.4%) 2 (1.5%) 1 (0.3%) <1% 0 6 (1.8%) Arthralgias 0 0 1 (0.3%) 3 (1.1%) 1 (1.3%) 5 (1.5%) Ear and Labyrinth Disorders Earache 2 (0.7%) 1 (0.7%) 0 8 (2.9%) 2 (2.7%) 0 Nervous System Disorders Headache 37 (13.9%) 12 (8.8%) 38 (11.3%) 69 (25.4%) 12 (16.0%) 23 (7.0%) *Ages 2-17 years Two cases of septic arthritis have been reported in infants less than one year of age in clinical trials conducted with ELIDEL Cream (n = 2,443). Causality has not been established.

adverse reactions table

<table> <caption>Treatment Emergent Adverse Events ( &#x2265;1%) in Elidel<sup>&#xAE;</sup> Treatment Groups</caption> <col width="141"/> <col width="62"/> <col width="62"/> <col width="114"/> <col width="21"/> <col width="73"/> <col width="62"/> <col width="104"/> <tbody> <tr> <td valign="bottom"/> <td colspan="2" valign="bottom" align="center"> <content styleCode="bold">Pediatric</content> <content styleCode="bold"> P</content> <content styleCode="bold">atients*</content> <content styleCode="bold"> </content> <content styleCode="bold">Vehicle-Controlled</content> <content styleCode="bold"> </content> <content styleCode="bold">(6 weeks)</content> </td> <td valign="bottom" align="center"> <content styleCode="bold">Pediatric</content> <content styleCode="bold"> </content> <content styleCode="bold">Patients*</content> <content styleCode="bold"> </content> <content styleCode="bold">Open-Label</content> <content styleCode="bold">(20 weeks)</content> </td> <td valign="bottom" align="center"/> <td colspan="2" valign="bottom" align="center"> <content styleCode="bold">Pediatric Patients*</content> <content styleCode="bold"> </content> <content styleCode="bold">Vehicle-Controlled</content> <content styleCode="bold"> </content> <content styleCode="bold">(1 year)</content> </td> <td valign="bottom" align="center"> <content styleCode="bold">Adult A</content> <content styleCode="bold">ctive</content> <content styleCode="bold"> </content> <content styleCode="bold">Comparator</content> <content styleCode="bold">(1 year)</content> </td> </tr> <tr> <td styleCode="Toprule " valign="bottom"/> <td styleCode="Toprule " valign="bottom" align="center">Elidel<sup>&#xAE;</sup> Cream (N=267) N (%)</td> <td styleCode="Toprule " valign="bottom" align="center">Vehicle (N=136) N (%)</td> <td styleCode="Toprule " valign="bottom" align="center">Elidel<sup>&#xAE;</sup> Cream (N=335) N (%)</td> <td styleCode="Toprule " valign="bottom" align="center"/> <td styleCode="Toprule " valign="bottom" align="center">Elidel<sup>&#xAE;</sup> Cream (N=272) N (%)</td> <td styleCode="Toprule " valign="bottom" align="center">Vehicle (N=75) N (%)</td> <td styleCode="Toprule " valign="bottom" align="center">Elidel<sup>&#xAE;</sup> Cream (N=328) N (%)</td> </tr> <tr> <td styleCode="Toprule " valign="bottom">At least 1 AE</td> <td styleCode="Toprule " valign="bottom" align="center">182 (68.2%)</td> <td styleCode="Toprule " valign="bottom" align="center">97 (71.3%)</td> <td styleCode="Toprule " valign="bottom" align="center">240 (72.0%)</td> <td styleCode="Toprule " valign="bottom" align="center"/> <td styleCode="Toprule " valign="bottom" align="center">230 (84.6%)</td> <td styleCode="Toprule " valign="bottom" align="center">56 (74.7%)</td> <td styleCode="Toprule " valign="bottom" align="center">256 (78.0%)</td> </tr> <tr> <td styleCode="Toprule " colspan="8" valign="bottom"> <content styleCode="bold">Infections and Infestations</content> </td> </tr> <tr> <td valign="bottom">Upper Respiratory Tract Infection NOS</td> <td valign="bottom" align="center">38 (14.2%)</td> <td valign="bottom" align="center">18 (13.2%)</td> <td valign="bottom" align="center">65 (19.4%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">13 (4.8%)</td> <td valign="bottom" align="center">6 (8.0%)</td> <td valign="bottom" align="center">14 (4.3%)</td> </tr> <tr> <td valign="bottom">Nasopharyngitis</td> <td valign="bottom" align="center">27 (10.1%)</td> <td valign="bottom" align="center">10 (7.4%)</td> <td valign="bottom" align="center">32 (19.6%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">72 (26.5%)</td> <td valign="bottom" align="center">16 (21.3%)</td> <td valign="bottom" align="center">25 (7.6%)</td> </tr> <tr> <td valign="bottom">Skin Infection NOS</td> <td valign="bottom" align="center">8 (3.0%)</td> <td valign="bottom" align="center">9 (5.1%)</td> <td valign="bottom" align="center">18 (5.4%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">6 (2.2%)</td> <td valign="bottom" align="center">3 (4.0%)</td> <td valign="bottom" align="center">21 (6.4%)</td> </tr> <tr> <td valign="bottom">Influenza</td> <td valign="bottom" align="center">8 (3.0%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">22 (6.6%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">36 (13.2%)</td> <td valign="bottom" align="center">3 (4.0%)</td> <td valign="bottom" align="center">32 (9.8%)</td> </tr> <tr> <td valign="bottom">Ear Infection NOS</td> <td valign="bottom" align="center">6 (2.2%)</td> <td valign="bottom" align="center">2 (1.5%)</td> <td valign="bottom" align="center">19 (5.7%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">9 (3.3%)</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">2 (0.6%)</td> </tr> <tr> <td valign="bottom">Otitis Media</td> <td valign="bottom" align="center">6 (2.2%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">10 (3.0%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">8 (2.9%)</td> <td valign="bottom" align="center">4 (5.3%)</td> <td valign="bottom" align="center">2 (0.6%)</td> </tr> <tr> <td valign="bottom">Impetigo</td> <td valign="bottom" align="center">5 (1.9%)</td> <td valign="bottom" align="center">3 (2.2%)</td> <td valign="bottom" align="center">12 (3.6%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">11 (4.0%)</td> <td valign="bottom" align="center">4 (5.3%)</td> <td valign="bottom" align="center">8 (2.4%)</td> </tr> <tr> <td valign="bottom">Bacterial Infection</td> <td valign="bottom" align="center">4 (1.5%)</td> <td valign="bottom" align="center">3 (2.2%)</td> <td valign="bottom" align="center">4 (1.2%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">6 (1.8%)</td> </tr> <tr> <td valign="bottom">Folliculitis</td> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">3 (0.9%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">6 (2.2%)</td> <td valign="bottom" align="center">3 (4.0%)</td> <td valign="bottom" align="center">20 (6.1%)</td> </tr> <tr> <td valign="bottom">Sinusitis </td> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">11 (3.3%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">6 (2.2%)</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">2 (0.6%)</td> </tr> <tr> <td valign="bottom">Pneumonia NOS</td> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">5 (1.5%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">1 (0.3%)</td> </tr> <tr> <td valign="bottom">Pharyngitis NOS</td> <td valign="bottom" align="center">2 (0.7%)</td> <td valign="bottom" align="center">2 (1.5%)</td> <td valign="bottom" align="center">3 (0.9%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">22 (8.1%)</td> <td valign="bottom" align="center">2 (2.7%)</td> <td valign="bottom" align="center">3 (0.9%)</td> </tr> <tr> <td valign="bottom">Pharyngitis Streptococcal</td> <td valign="bottom" align="center">2 (0.7%)</td> <td valign="bottom" align="center">2 (1.5%)</td> <td valign="bottom" align="center">10 (3.0%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td valign="bottom">Molluscum Contagiosum</td> <td valign="bottom" align="center">2 (0.7%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">4 (1.2%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">5 (1.8%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td valign="bottom">Staphylococcal Infection</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">5 (3.7%)</td> <td valign="bottom" align="center">7 (2.1%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">3 (0.9%)</td> </tr> <tr> <td valign="bottom">Bronchitis NOS</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">3 (2.2%)</td> <td valign="bottom" align="center">4 (1.2%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">29 (10.7%)</td> <td valign="bottom" align="center">6 (8.0%)</td> <td valign="bottom" align="center">8 (2.4%)</td> </tr> <tr> <td valign="bottom">Herpes Simplex</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">4 (1.2%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">9 (3.3%)</td> <td valign="bottom" align="center">2 (2.7%)</td> <td valign="bottom" align="center">13 (4.0%)</td> </tr> <tr> <td valign="bottom">Tonsillitis NOS</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">3 (0.9%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">17 (6.3%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">2 (0.6%)</td> </tr> <tr> <td valign="bottom">Viral Infection NOS</td> <td valign="bottom" align="center">2 (0.7%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">1 (0.3%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">18 (6.6%)</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td valign="bottom">Gastroenteritis NOS</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">3 (2.2%)</td> <td valign="bottom" align="center">2 (0.6%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">20 (7.4%)</td> <td valign="bottom" align="center">2 (2.7%)</td> <td valign="bottom" align="center">6 (1.8%)</td> </tr> <tr> <td valign="bottom">Chickenpox</td> <td valign="bottom" align="center">2 (0.7%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">3 (0.9%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">8 (2.9%)</td> <td valign="bottom" align="center">3 (4.0%)</td> <td valign="bottom" align="center">1 (0.3%)</td> </tr> <tr> <td valign="bottom">Skin Papilloma</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">2 (0.6%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">9 (3.3%)</td> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td valign="bottom">Tonsillitis Acute NOS</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">7 (2.6%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td valign="bottom">Upper Respiratory Tract Infection Viral NOS</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">3 (0.9%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">4 (1.5%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">1 (0.3%)</td> </tr> <tr> <td valign="bottom">Herpes Simplex Dermatitis</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">1 (0.3%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">4 (1.5%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">2 (0.6%)</td> </tr> <tr> <td valign="bottom">Bronchitis Acute NOS</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">4 (1.5%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td valign="bottom">Eye Infection NOS</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">1 (0.3%)</td> </tr> <tr> <td styleCode="Toprule " colspan="8" valign="bottom"> <content styleCode="bold">General Disorders </content> <content styleCode="bold">and Administration Site Conditions</content> </td> </tr> <tr> <td valign="bottom">Application Site Burning</td> <td valign="bottom" align="center">28 (10.4%)</td> <td valign="bottom" align="center">17 (12.5%)</td> <td valign="bottom" align="center">5 (1.5%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">23 (8.5%)</td> <td valign="bottom" align="center">5 (6.7%)</td> <td valign="bottom" align="center">85 (25.9%)</td> </tr> <tr> <td valign="bottom">Pyrexia</td> <td valign="bottom" align="center">20 (7.5%)</td> <td valign="bottom" align="center">12 (8.8%)</td> <td valign="bottom" align="center">41 (12.2%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">34 (12.5%)</td> <td valign="bottom" align="center">4 (5.3%)</td> <td valign="bottom" align="center">4 (1.2%)</td> </tr> <tr> <td valign="bottom">Application Site Reaction NOS</td> <td valign="bottom" align="center">8 (3.0%)</td> <td valign="bottom" align="center">7 (5.1%)</td> <td valign="bottom" align="center">7 (2.1%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">9 (3.3%)</td> <td valign="bottom" align="center">2 (2.7%)</td> <td valign="bottom" align="center">48 (14.6%)</td> </tr> <tr> <td valign="bottom">Application Site Irritation</td> <td valign="bottom" align="center">8 (3.0%)</td> <td valign="bottom" align="center">8 (5.9%)</td> <td valign="bottom" align="center">3 (0.9%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">3 (4.0%)</td> <td valign="bottom" align="center">21 (6.4%)</td> </tr> <tr> <td valign="bottom">Influenza Like Illness</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">2 (0.6%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">5 (1.8%)</td> <td valign="bottom" align="center">2 (2.7%)</td> <td valign="bottom" align="center">6 (1.8%)</td> </tr> <tr> <td valign="bottom">Application Site Erythema</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">6 (2.2%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">7 (2.1%)</td> </tr> <tr> <td valign="bottom">Application Site Pruritus</td> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">2 (1.5%)</td> <td valign="bottom" align="center">2 (0.6%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">5 (1.8%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">18 (5.5%)</td> </tr> <tr> <td styleCode="Toprule " colspan="8" valign="bottom"> <content styleCode="bold">Respiratory, Thoracic and </content> <content styleCode="bold">Mediastinal Disorders</content> </td> </tr> <tr> <td valign="bottom">Cough</td> <td valign="bottom" align="center">31 (11.6%)</td> <td valign="bottom" align="center">11 (8.1%)</td> <td valign="bottom" align="center">31 (9.3%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">43 (15.8%)</td> <td valign="bottom" align="center">8 (10.7%)</td> <td valign="bottom" align="center">8 (2.4%)</td> </tr> <tr> <td valign="bottom">Nasal Congestion</td> <td valign="bottom" align="center">7 (2.6%)</td> <td valign="bottom" align="center">2 (1.5%)</td> <td valign="bottom" align="center">6 (1.8%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">4 (1.5%)</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">2 (0.6%)</td> </tr> <tr> <td valign="bottom">Rhinorrhea</td> <td valign="bottom" align="center">5 (1.9%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">3 (0.9%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td valign="bottom">Asthma Aggravated</td> <td valign="bottom" align="center">4 (1.5%)</td> <td valign="bottom" align="center">3 (2.2%)</td> <td valign="bottom" align="center">13 (3.9%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td valign="bottom">Sinus Congestion</td> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">2 (0.6%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">3 (0.9%)</td> </tr> <tr> <td valign="bottom">Rhinitis</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">5 (1.5%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">12 (4.4%)</td> <td valign="bottom" align="center">5 (6.7%)</td> <td valign="bottom" align="center">7 (2.1%)</td> </tr> <tr> <td valign="bottom">Wheezing</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">4 (1.2%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">2 (0.7%)</td> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td valign="bottom">Asthma NOS</td> <td valign="bottom" align="center">2 (0.7%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">11 (3.3%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">10 (3.7%)</td> <td valign="bottom" align="center">2 (2.7%)</td> <td valign="bottom" align="center">8 (2.4%)</td> </tr> <tr> <td valign="bottom">Epistaxis</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">9 (3.3%)</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">1 (0.3%)</td> </tr> <tr> <td valign="bottom">Dyspnea NOS</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">5 (1.8%)</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">2 (0.6%)</td> </tr> <tr> <td styleCode="Toprule " colspan="8" valign="bottom"> <content styleCode="bold">Gastrointestinal Disorders</content> </td> </tr> <tr> <td valign="bottom">Abdominal Pain Upper</td> <td valign="bottom" align="center">11 (4.1%)</td> <td valign="bottom" align="center">6 (4.4%)</td> <td valign="bottom" align="center">10 (3.0%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">15 (5.5%)</td> <td valign="bottom" align="center">5 (6.7%)</td> <td valign="bottom" align="center">1 (0.3%)</td> </tr> <tr> <td valign="bottom">Sore Throat</td> <td valign="bottom" align="center">9 (3.4%)</td> <td valign="bottom" align="center">5 (3.7%)</td> <td valign="bottom" align="center">15 (5.4%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">22 (8.1%)</td> <td valign="bottom" align="center">4 (5.3%)</td> <td valign="bottom" align="center">12 (3.7%)</td> </tr> <tr> <td valign="bottom">Vomiting NOS</td> <td valign="bottom" align="center">8 (3.0%)</td> <td valign="bottom" align="center">6 (4.4%)</td> <td valign="bottom" align="center">14 (4.2%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">18 (6.6%)</td> <td valign="bottom" align="center">6 (8.0%)</td> <td valign="bottom" align="center">2 (0.6%)</td> </tr> <tr> <td valign="bottom">Diarrhea NOS</td> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">2 (0.6%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">21 (7.7%)</td> <td valign="bottom" align="center">4 (5.3%)</td> <td valign="bottom" align="center">7 (2.1%)</td> </tr> <tr> <td valign="bottom">Nausea </td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">3 (2.2%)</td> <td valign="bottom" align="center">4 (1.2%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">11 (4.0%)</td> <td valign="bottom" align="center">5 (6.7%)</td> <td valign="bottom" align="center">6 (1.8%)</td> </tr> <tr> <td valign="bottom">Abdominal Pain NOS</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">5 (1.5%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">12 (4.4%)</td> <td valign="bottom" align="center">3 (4.0%)</td> <td valign="bottom" align="center">1 (0.3%)</td> </tr> <tr> <td valign="bottom">Toothache</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">2 (0.6%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">7 (2.6%)</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">2 (0.6%)</td> </tr> <tr> <td valign="bottom">Constipation</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">2 (0.6%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">10 (3.7%)</td> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td valign="bottom">Loose Stools</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">4 (1.2%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td styleCode="Toprule " colspan="8" valign="bottom"> <content styleCode="bold">Reproductive System and Breast Disorders</content> </td> </tr> <tr> <td valign="bottom">Dysmenorrhea</td> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">5 (1.5%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">4 (1.2%)</td> </tr> <tr> <td styleCode="Toprule " colspan="8" valign="bottom"> <content styleCode="bold">Eye Disorders</content> </td> </tr> <tr> <td valign="bottom">Conjunctivitis NEC</td> <td valign="bottom" align="center">2 (0.7%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">7 (2.1%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">6 (2.2%)</td> <td valign="bottom" align="center">3 (4.0%)</td> <td valign="bottom" align="center">10 (3.0%)</td> </tr> <tr> <td styleCode="Toprule " colspan="8" valign="bottom"> <content styleCode="bold">Skin &amp; Subcutaneous Tissue Disorders</content> </td> </tr> <tr> <td valign="bottom">Urticaria</td> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">1 (0.3%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">3 (0.9%)</td> </tr> <tr> <td valign="bottom">Acne NOS</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">1 (0.3%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">4 (1.5%)</td> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">6 (1.8%)</td> </tr> <tr> <td styleCode="Toprule " colspan="8" valign="bottom"> <content styleCode="bold">Immune System Disorders</content> </td> </tr> <tr> <td valign="bottom">Hypersensitivity NOS</td> <td valign="bottom" align="center">11 (4.1%)</td> <td valign="bottom" align="center">6 (4.4%)</td> <td valign="bottom" align="center">16 (4.8%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">14 (5.1%)</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">11 (3.4%)</td> </tr> <tr> <td styleCode="Toprule " colspan="8" valign="bottom"> <content styleCode="bold">Injury and Poisoning</content> </td> </tr> <tr> <td valign="bottom">Accident NOS</td> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">1 (0.3%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td valign="bottom">Laceration</td> <td valign="bottom" align="center">2 (0.7%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">5 (1.5%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td styleCode="Toprule " colspan="8" valign="bottom"> <content styleCode="bold">Musculoskeletal, Connective</content> <content styleCode="bold"> Tissue and Bone Disorders</content> </td> </tr> <tr> <td valign="bottom">Back Pain</td> <td valign="bottom" align="center">1 (0.4%)</td> <td valign="bottom" align="center">2 (1.5%)</td> <td valign="bottom" align="center">1 (0.3%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">&lt;1%</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">6 (1.8%)</td> </tr> <tr> <td valign="bottom">Arthralgias</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center">1 (0.3%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">3 (1.1%)</td> <td valign="bottom" align="center">1 (1.3%)</td> <td valign="bottom" align="center">5 (1.5%)</td> </tr> <tr> <td styleCode="Toprule " colspan="8" valign="bottom"> <content styleCode="bold">Ear and Labyrinth Disorders</content> </td> </tr> <tr> <td valign="bottom">Earache</td> <td valign="bottom" align="center">2 (0.7%)</td> <td valign="bottom" align="center">1 (0.7%)</td> <td valign="bottom" align="center">0</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">8 (2.9%)</td> <td valign="bottom" align="center">2 (2.7%)</td> <td valign="bottom" align="center">0</td> </tr> <tr> <td styleCode="Toprule " colspan="8" valign="bottom"> <content styleCode="bold">Nervous System Disorders</content> </td> </tr> <tr> <td valign="bottom">Headache</td> <td valign="bottom" align="center">37 (13.9%)</td> <td valign="bottom" align="center">12 (8.8%)</td> <td valign="bottom" align="center">38 (11.3%)</td> <td valign="bottom" align="center"/> <td valign="bottom" align="center">69 (25.4%)</td> <td valign="bottom" align="center">12 (16.0%)</td> <td valign="bottom" align="center">23 (7.0%)</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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