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FDA label c21cfbda-8878-4586-b356-77ba949bd877

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SPL set ID
6f94f6e7-3218-4271-86b5-2265b68d920d
SPL ID
c21cfbda-8878-4586-b356-77ba949bd877
Version
1
Effective date
2009-08-09
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:34:33

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 Patients*Vehicle-Controlled(6 weeks) Pediatric Patients* Open-Label (20 weeks) Pediatric Patients* Vehicle-Controlled(1 year) Adult Active 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 ID="i80faf4f0-fb4a-432d-873d-61f00ee2659e"> <caption>Treatment Emergent Adverse Events (&#x2265; 1%) in Elidel<sup>&#xAE;</sup> Treatment Groups</caption> <col width="122"/> <col width="64"/> <col width="98"/> <col width="108"/> <col width="17"/> <col width="77"/> <col width="100"/> <col width="106"/> <tbody> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " colspan="2" valign="bottom"> <content styleCode="bold">Pediatric Patients*Vehicle-Controlled(6 weeks)</content> </td> <td styleCode="Toprule Lrule Rrule " valign="bottom"> <content styleCode="bold">Pediatric Patients* Open-Label (20 weeks)</content> </td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " colspan="2" valign="bottom"> <content styleCode="bold">Pediatric Patients* Vehicle-Controlled(1 year)</content> </td> <td styleCode="Toprule Lrule Rrule " valign="bottom"> <content styleCode="bold">Adult Active</content> <content styleCode="bold"> Comparator (1 year)</content> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">Elidel&#xAE; Cream (N=267) N (%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">Vehicle(N=136) N (%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">Elidel&#xAE; Cream (N=335) N (%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">Elidel&#xAE; Cream (N=272) N (%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">Vehicle(N=75) N (%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">Elidel&#xAE; Cream(N=328)N (%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">At least 1 AE</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">182 (68.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">97 (71.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">240 (72.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">230 (84.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">56 (74.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">256 (78.0%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " colspan="8" valign="bottom"> <content styleCode="bold">Infections and Infestations</content> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Upper Respiratory Tract Infection NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">38 (14.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">18 (13.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">65 (19.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">13 (4.8%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (8.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">14 (4.3%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Nasopharyngitis</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">27 (10.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">10 (7.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">32 (19.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">72 (26.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">16 (21.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">25 (7.6%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Skin Infection NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (3.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">9 (5.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">18 (5.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (4.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">21 (6.4%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Influenza</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (3.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">22 (6.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">36 (13.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (4.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">32 (9.8%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Ear Infection NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">19 (5.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">9 (3.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Otitis Media</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">10 (3.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (2.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (5.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Impetigo</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">12 (3.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">11 (4.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (5.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (2.4%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Bacterial Infection</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (1.8%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Folliculitis</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (0.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (4.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">20 (6.1%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Sinusitis </td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">11 (3.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Pneumonia NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Pharyngitis NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (0.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">22 (8.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (2.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (0.9%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Pharyngitis Streptococcal</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">10 (3.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Molluscum Contagiosum</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.8%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Staphylococcal Infection</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (3.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">7 (2.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (0.9%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Bronchitis NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">29 (10.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (8.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (2.4%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Herpes Simplex</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">9 (3.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (2.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">13 (4.0%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Tonsillitis NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (0.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">17 (6.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Viral Infection NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">18 (6.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Gastroenteritis NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">20 (7.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (2.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (1.8%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Chickenpox</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (0.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (2.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (4.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Skin Papilloma</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">9 (3.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Tonsillitis Acute NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">7 (2.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Upper Respiratory Tract Infection Viral NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (0.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Herpes Simplex Dermatitis</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Bronchitis Acute NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Eye Infection NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " colspan="8" valign="bottom"> <content styleCode="bold">General Disorders and Administration Site Conditions</content> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Application Site Burning</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">28 (10.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">17 (12.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">23 (8.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (6.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">85 (25.9%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Pyrexia</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">20 (7.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">12 (8.8%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">41 (12.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">34 (12.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (5.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.2%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Application Site Reaction NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (3.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">7 (5.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">7 (2.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">9 (3.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (2.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">48 (14.6%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Application Site Irritation</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (3.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (5.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (0.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (4.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">21 (6.4%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Influenza Like Illness</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.8%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (2.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (1.8%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Application Site Erythema</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">7 (2.1%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Application Site Pruritus</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.8%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">18 (5.5%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " colspan="8" valign="bottom"> <content styleCode="bold">Respiratory, Thoracic and Mediastinal Disorders</content> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Cough</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">31 (11.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">11 (8.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">31 (9.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">43 (15.8%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (10.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (2.4%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Nasal Congestion</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">7 (2.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (1.8%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Rhinorrhea</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (0.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Asthma Aggravated</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">13 (3.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Sinus Congestion</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (0.9%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Rhinitis</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">12 (4.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (6.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">7 (2.1%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Wheezing</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Asthma NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">11 (3.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">10 (3.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (2.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (2.4%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Epistaxis</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">9 (3.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Dyspnea NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.8%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " colspan="8" valign="bottom"> <content styleCode="bold">Gastrointestinal Disorders</content> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Abdominal Pain Upper</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">11 (4.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (4.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">10 (3.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">15 (5.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (6.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Sore Throat</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">9 (3.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (3.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">15 (5.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">22 (8.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (5.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">12 (3.7%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Vomiting NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (3.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (4.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">14 (4.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">18 (6.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (8.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Diarrhea NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">21 (7.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (5.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">7 (2.1%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Nausea </td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">11 (4.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (6.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (1.8%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Abdominal Pain NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">12 (4.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (4.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Toothache</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">7 (2.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Constipation</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.6%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">10 (3.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Loose Stools</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " colspan="8" valign="bottom"> <content styleCode="bold">Reproductive System and Breast Disorders</content> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Dysmenorrhea</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.2%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom"> <content styleCode="bold">Eye Disorders</content> </td> <td styleCode="Toprule Lrule Rrule " valign="bottom"> </td> <td styleCode="Toprule Lrule Rrule " valign="bottom"> </td> <td styleCode="Toprule Lrule Rrule " valign="bottom"> </td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom"> </td> <td styleCode="Toprule Lrule Rrule " valign="bottom"> </td> <td styleCode="Toprule Lrule Rrule " valign="bottom"> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Conjunctivitis NEC</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">7 (2.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (2.2%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (4.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">10 (3.0%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " colspan="8" valign="bottom"> <content styleCode="bold">Skin &amp; Subcutaneous Tissue Disorders</content> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Urticaria</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (0.9%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Acne NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">4 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (1.8%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " colspan="8" valign="bottom"> <content styleCode="bold">Immune System Disorders</content> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Hypersensitivity NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">11 (4.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (4.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">16 (4.8%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">14 (5.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">11 (3.4%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " colspan="8" valign="bottom"> <content styleCode="bold">Injury and Poisoning</content> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Accident NOS</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Laceration</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " colspan="8" valign="bottom"> <content styleCode="bold">Musculoskeletal, Connective Tissue and Bone Disorders</content> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Back Pain</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (1.5%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">&lt;1%</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">6 (1.8%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Arthralgias</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">3 (1.1%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (1.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">5 (1.5%)</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " colspan="8" valign="bottom"> <content styleCode="bold">Ear and Labyrinth Disorders</content> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Earache</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">1 (0.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">8 (2.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">2 (2.7%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">0</td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " colspan="8" valign="bottom"> <content styleCode="bold">Nervous System Disorders</content> </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " valign="bottom">Headache</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">37 (13.9%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">12 (8.8%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">38 (11.3%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom"/> <td styleCode="Toprule Lrule Rrule " valign="bottom">69 (25.4%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">12 (16.0%)</td> <td styleCode="Toprule Lrule Rrule " valign="bottom">23 (7.0%)</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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