Home FDA labels fe2c1882-a890-4afa-92f0-ab309e25de94 FDA label fe2c1882-a890-4afa-92f0-ab309e25de94 openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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SPL set ID 2c718fc7-2921-4d02-b273-784e513f8299
SPL ID fe2c1882-a890-4afa-92f0-ab309e25de94
Version 12
Effective date 2016-09-07
Source export date 2026-10-12
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Source file https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
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Import run 20261013T011858Z
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warnings WARNINGS THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF EIGHT YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH. This adverse reaction is more common during long-term use of the drugs, but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, OR IN PREGNANT WOMEN, UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy, the patient should be apprised of the potential hazard to the fetus. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking doxycycline or other tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs.
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adverse reactions ADVERSE REACTIONS In clinical trials involving a total of 1436 patients, adverse experiences from all causalities were monitored across treatment groups. In the Circulatory System category, 10 subjects (1.6%) in the ATRIDOX ® group were reported as having "unspecified essential hypertension." Only 1 subject (0.2%) in the Vehicle group, and none in the Scaling and Root Planing or Oral Hygiene groups were reported to have "unspecified essential hypertension." In all cases, the event occurred anywhere from 13 to 134 days post treatment. There is no known association of oral administration of doxycycline with essential hypertension. Two patients in the polymer vehicle group and none in the ATRIDOX ® group (0.2% for both groups combined) reported adverse events consistent with a localized allergic response. Sex, age, race and smoking status did not appear to be correlated with adverse events. The following table lists the incidence of treatment-emergent adverse events from all causalities, across all treatment groups, occurring in ≥1% of the entire study population. Body System Doxycycline Vehicle OH SRP Verbatim Terms n=609 n=413 n=204 n=210 Circulatory High blood pressure 1.6% 0.2% 0.0% 0.0% Digestive Gum discomfort, pain or soreness; loss of attachment; increased pocket depth 18.1% 23.0% 20.1% 21.0% Toothache, pressure sensitivity 14.3% 14.3% 10.3% 18.1% Periodontal abscess, exudate, infection, drainage, extreme mobility, suppuration 9.9% 10.9% 10.3% 8.6% Thermal tooth sensitivity 7.7% 8.5% 4.4% 6.7% Gum inflammation, swelling, sensitivity 4.1% 5.8% 5.4% 5.7% Soft tissue erythema, sore mouth, unspecified pain 4.3% 5.3% 2.7% 6.2% Indigestion, upset stomach, stomachache 3.6% 4.1% 2.9% 3.8% Diarrhea 3.3% 2.4% 1.0% 1.0% Tooth mobility, bone loss 2.0% 0.7% 0.5% 2.4% Periapical abscess, lesion 1.5% 1.9% 1.0% 0.5% Aphthous ulcer, canker sores 0.7% 1.7% 1.0% 1.4% Fistula 0.8% 1.5% 1.5% 1.0% Endodontic abscess, pulpitis 1.5% 1.5% 0.0% 0.5% Jaw pain 1.1% 0.5% 1.0% 1.9% Tooth loss 0.8% 1.5% 1.5% 0.0% Bleeding gums 1.0% 0.7% 0.0% 2.4% Genitourinary Premenstrual tension syndrome 4.4% 3.1% 2.5% 3.3% Ill-Defined Conditions Headache 27.3% 28.1% 23.5% 23.8% Cough 3.6% 6.1% 2.9% 2.4% Sleeplessness 3.4% 1.5% 2.0% 2.9% Body aches, soreness 1.6% 1.2% 1.5% 1.4% Nausea and vomiting 1.8% 0.7% 2.5% 0.5% Fever 1.0% 1.9% 1.0% 1.9% Injury & Poisoning Broken tooth 5.1% 4.1% 4.9% 5.7% Mental Tension headache 1.8% 0.7% 0.0% 1.0% Musculoskeletal Muscle aches 6.4% 4.6% 4.9% 3.3% Backache 3.6% 5.3% 2.5% 6.2% Pain in arms or legs 1.5% 2.2% 2.0% 2.4% Lower back pain 1.6% 1.7% 0.5% 2.9% Neck pain 1.3% 1.7% 1.0% 1.9% Shoulder pain 1.0% 1.0% 1.5% 1.0% Nervous System Ear infection 1.6% 1.9% 2.0% 0.0% Respiratory Common cold 25.5% 25.2% 18.1% 16.7% Flu, respiratory 6.1% 9.0% 3.9% 6.7% Stuffy head, post nasal drip, congestion 5.6% 7.7% 2.9% 4.8% Sore throat 5.7% 6.5% 2.0% 3.3% Sinus infection 5.3% 2.7% 1.0% 1.9% Flu 2.8% 2.9% 2.9% 3.3% Bronchitis 2.3% 1.9% 1.5% 1.0% Allergies 1.0% 1.0% 1.0% 1.9% Skin & Subcutaneous Tissue Skin infection or inflammation 1.3% 1.0% 1.0% 1.0%
adverse reactions table <table> <col/> <col/> <col/> <col/> <col/> <thead> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Body System</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Doxycycline</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Vehicle</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> OH</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> SRP</td> </tr> </thead> <tbody> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Verbatim Terms</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> n=609</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> n=413</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> n=204</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> n=210</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold"> <content styleCode="underline">Circulatory</content> </content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> High blood pressure</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.6%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.2%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.0%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold"> <content styleCode="underline">Digestive</content> </content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Gum discomfort, pain or soreness; loss of attachment; increased pocket depth</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 18.1%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 23.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 20.1%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 21.0%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Toothache, pressure sensitivity</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 14.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 14.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 10.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 18.1%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Periodontal abscess, exudate, infection, drainage, extreme mobility, suppuration</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 9.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 10.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 10.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 8.6%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Thermal tooth sensitivity</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 7.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 8.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 4.4%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 6.7%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Gum inflammation, swelling, sensitivity</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 4.1%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 5.8%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 5.4%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 5.7%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Soft tissue erythema, sore mouth, unspecified pain</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 4.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 5.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 6.2%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Indigestion, upset stomach, stomachache</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 3.6%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 4.1%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 3.8%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Diarrhea</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 3.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.4%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Tooth mobility, bone loss</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.4%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Periapical abscess, lesion</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.5%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Aphthous ulcer, canker sores</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.4%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Fistula</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.8%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Endodontic abscess, pulpitis</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.5%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Jaw pain</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.1%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.9%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Tooth loss</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.8%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.0%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Bleeding gums</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.4%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold"> <content styleCode="underline">Genitourinary</content> </content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Premenstrual tension syndrome</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 4.4%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 3.1%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 3.3%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold"> <content styleCode="underline">Ill-Defined Conditions</content> </content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Headache</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 27.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 28.1%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 23.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 23.8%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Cough</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 3.6%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 6.1%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.4%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Sleeplessness</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 3.4%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.9%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Body aches, soreness</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.6%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.2%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.4%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Nausea and vomiting</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.8%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.5%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Fever</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.9%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold"> <content styleCode="underline">Injury & Poisoning</content> </content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Broken tooth</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 5.1%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 4.1%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 4.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 5.7%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold"> <content styleCode="underline">Mental</content> </content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Tension headache</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.8%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold"> <content styleCode="underline">Musculoskeletal</content> </content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Muscle aches</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 6.4%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 4.6%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 4.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 3.3%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Backache</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 3.6%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 5.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 6.2%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Pain in arms or legs</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.2%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.4%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Lower back pain</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.6%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.9%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Neck pain</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.9%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Shoulder pain</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold"> <content styleCode="underline">Nervous System</content> </content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Ear infection</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.6%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 0.0%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold"> <content styleCode="underline">Respiratory</content> </content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Common cold</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 25.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 25.2%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 18.1%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 16.7%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Flu, respiratory</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 6.1%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 9.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 3.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 6.7%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Stuffy head, post nasal drip, congestion</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 5.6%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 7.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 4.8%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Sore throat</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 5.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 6.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 3.3%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Sinus infection</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 5.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.7%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.9%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Flu</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.8%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 3.3%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Bronchitis</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 2.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.9%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.5%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Allergies</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.9%</td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold"> <content styleCode="underline">Skin & Subcutaneous Tissue</content> </content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> </td> </tr> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule Rrule "> Skin infection or inflammation</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.3%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> 1.0%</td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.