Home FDA labels 514f9bec-e477-404c-8c64-27c74fdaeb44 FDA label 514f9bec-e477-404c-8c64-27c74fdaeb44 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 743ada1c-0f04-43ea-be7d-1560164e6f6e
SPL ID 514f9bec-e477-404c-8c64-27c74fdaeb44
Version 3
Effective date 2012-10-31
Source export date 2026-09-28
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/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
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warnings WARNINGS Mesalamine Rectal Suspension Enema contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but probably low. Sulfite sensitivity is seen more frequently in asthmatic or in atopic nonasthmatic persons. Epinephrine is the preferred treatment for serious allergic or emergency situations even though epinephrine injection contains sodium or potassium metabisulfite with the above-mentioned potential liabilities. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite(s) in epinephrine injection should not deter the administration of the drug for treatment of serious allergic or other emergency situations.
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adverse reactions ADVERSE REACTIONS Clinical Adverse Experience Mesalamine Rectal Suspension Enema is usually well tolerated. Most adverse effects have been mild and transient. ADVERSE REACTIONS OCCURING IN MORE THAN 0.1% OF MESALAMINE RECTAL SUSPENSION ENEMA TREATED PATIENTS (COMPARISON TO PLACEBO) Mesalamine Rectal Suspension Enema Placebo N = 815 N = 128 SYMPTOM N % N % Abdominal Pain/Cramps/Discomfort 66 8.10 10 7.81 Headache 53 6.50 16 12.50 Gas/Flatulence 50 6.13 5 3.91 Nausea 47 5.77 12 9.38 Flu 43 5.28 1 0.78 Tired/Weak/Malaise/Fatigue 28 3.44 8 6.25 Fever 26 3.19 0 0.00 Rash/Spots 23 2.82 4 3.12 Cold/Sore Throat 19 2.33 9 7.03 Diarrhea 17 2.09 5 3.91 Leg/Joint Pain 17 2.09 1 0.78 Dizziness 15 1.84 3 2.34 Bloating 12 1.47 2 1.56 Back Pain 11 1.35 1 0.78 Pain on Insertion of Enema Tip 11 1.35 1 0.78 Hemorrhoids 11 1.35 0 0.00 Itching 10 1.23 1 0.78 Rectal Pain 10 1.23 0 0.00 Constipation 8 0.98 4 3.12 Hair Loss 7 0.86 0 0.00 Peripheral Edema 5 0.61 11 8.59 UTI/Urinary Burning 5 0.61 4 3.12 Rectal Pain/Soreness/Burning 5 0.61 3 2.34 Asthenia 1 0.12 4 3.12 Insomnia 1 0.12 3 2.34 In addition, the following adverse events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice; nephrotoxicity, pancreatitis, fibrosing alveolitis and elevated liver enzymes. Cases of pancreatitis and fibrosing alveolitis have been reported as manifestations of inflammatory bowel disease as well. Published case reports and/or spontaneous post marketing surveillance have described rare instances of aplastic anemia, agranulocytosis, thrombocytopenia, eosinophilia, pancytopenia, neutropenia, oligospermia, and infertility in men. Anemia, leukocytosis, and thrombocytosis can be part of the clinical presentation of inflammatory bowel disease. Hair Loss Mild hair loss characterized by "more hair in the comb" but no withdrawal from clinical trials has been observed in 7 of 815 mesalamine patients but none of the placebo-treated patients. In the literature there are at least six additional patients with mild hair loss who received either mesalamine of sulfasalazine. Retreatment is not always associated with repeated hair loss.
adverse reactions table <table ID="_RefID0ECBAE" width="100%"> <caption>ADVERSE REACTIONS OCCURING IN MORE THAN 0.1% OF MESALAMINE RECTAL SUSPENSION ENEMA TREATED PATIENTS (COMPARISON TO PLACEBO)</caption> <col width="60%"/> <col width="5%"/> <col width="15%"/> <col width="5%"/> <col width="15%"/> <thead> <tr> <th align="left" styleCode="Toprule " valign="top"/> <th align="left" colspan="2" styleCode="Toprule " valign="top"> <content styleCode="bold">Mesalamine</content> <content styleCode="bold">Rectal</content> <content styleCode="bold">Suspension</content> <content styleCode="bold">Enema</content> </th> <th align="left" colspan="2" styleCode="Toprule " valign="bottom"> <content styleCode="bold">Placebo</content> </th> </tr> <tr> <th align="left" valign="top"/> <th align="left" colspan="2" valign="top"> <content styleCode="bold">N = 815</content> </th> <th align="left" colspan="2" valign="top"> <content styleCode="bold">N = 128</content> </th> </tr> <tr> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">SYMPTOM</content> </th> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">N</content> </th> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">%</content> </th> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">N</content> </th> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">%</content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Toprule " valign="top"> <paragraph>Abdominal Pain/Cramps/Discomfort</paragraph> </td> <td styleCode="Toprule " valign="top"> <paragraph>66</paragraph> </td> <td styleCode="Toprule " valign="top"> <paragraph>8.10</paragraph> </td> <td styleCode="Toprule " valign="top"> <paragraph>10</paragraph> </td> <td styleCode="Toprule " valign="top"> <paragraph>7.81</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Headache</paragraph> </td> <td valign="top"> <paragraph>53</paragraph> </td> <td valign="top"> <paragraph>6.50</paragraph> </td> <td valign="top"> <paragraph>16</paragraph> </td> <td valign="top"> <paragraph>12.50</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Gas/Flatulence</paragraph> </td> <td valign="top"> <paragraph>50</paragraph> </td> <td valign="top"> <paragraph>6.13</paragraph> </td> <td valign="top"> <paragraph>5</paragraph> </td> <td valign="top"> <paragraph>3.91</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Nausea</paragraph> </td> <td valign="top"> <paragraph>47</paragraph> </td> <td valign="top"> <paragraph>5.77</paragraph> </td> <td valign="top"> <paragraph>12</paragraph> </td> <td valign="top"> <paragraph>9.38</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Flu</paragraph> </td> <td valign="top"> <paragraph>43</paragraph> </td> <td valign="top"> <paragraph>5.28</paragraph> </td> <td valign="top"> <paragraph>1</paragraph> </td> <td valign="top"> <paragraph>0.78</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Tired/Weak/Malaise/Fatigue</paragraph> </td> <td valign="top"> <paragraph>28</paragraph> </td> <td valign="top"> <paragraph>3.44</paragraph> </td> <td valign="top"> <paragraph>8</paragraph> </td> <td valign="top"> <paragraph>6.25</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Fever</paragraph> </td> <td valign="top"> <paragraph>26</paragraph> </td> <td valign="top"> <paragraph>3.19</paragraph> </td> <td valign="top"> <paragraph>0</paragraph> </td> <td valign="top"> <paragraph>0.00</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Rash/Spots</paragraph> </td> <td valign="top"> <paragraph>23</paragraph> </td> <td valign="top"> <paragraph>2.82</paragraph> </td> <td valign="top"> <paragraph>4</paragraph> </td> <td valign="top"> <paragraph>3.12</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Cold/Sore Throat</paragraph> </td> <td valign="top"> <paragraph>19</paragraph> </td> <td valign="top"> <paragraph>2.33</paragraph> </td> <td valign="top"> <paragraph>9</paragraph> </td> <td valign="top"> <paragraph>7.03</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Diarrhea</paragraph> </td> <td valign="top"> <paragraph>17</paragraph> </td> <td valign="top"> <paragraph>2.09</paragraph> </td> <td valign="top"> <paragraph>5</paragraph> </td> <td valign="top"> <paragraph>3.91</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Leg/Joint Pain</paragraph> </td> <td valign="top"> <paragraph>17</paragraph> </td> <td valign="top"> <paragraph>2.09</paragraph> </td> <td valign="top"> <paragraph>1</paragraph> </td> <td valign="top"> <paragraph>0.78</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Dizziness</paragraph> </td> <td valign="top"> <paragraph>15</paragraph> </td> <td valign="top"> <paragraph>1.84</paragraph> </td> <td valign="top"> <paragraph>3</paragraph> </td> <td valign="top"> <paragraph>2.34</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Bloating</paragraph> </td> <td valign="top"> <paragraph>12</paragraph> </td> <td valign="top"> <paragraph>1.47</paragraph> </td> <td valign="top"> <paragraph>2</paragraph> </td> <td valign="top"> <paragraph>1.56</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Back Pain</paragraph> </td> <td valign="top"> <paragraph>11</paragraph> </td> <td valign="top"> <paragraph>1.35</paragraph> </td> <td valign="top"> <paragraph>1</paragraph> </td> <td valign="top"> <paragraph>0.78</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Pain on Insertion of Enema Tip</paragraph> </td> <td valign="top"> <paragraph>11</paragraph> </td> <td valign="top"> <paragraph>1.35</paragraph> </td> <td valign="top"> <paragraph>1</paragraph> </td> <td valign="top"> <paragraph>0.78</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Hemorrhoids</paragraph> </td> <td valign="top"> <paragraph>11</paragraph> </td> <td valign="top"> <paragraph>1.35</paragraph> </td> <td valign="top"> <paragraph>0</paragraph> </td> <td valign="top"> <paragraph>0.00</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Itching</paragraph> </td> <td valign="top"> <paragraph>10</paragraph> </td> <td valign="top"> <paragraph>1.23</paragraph> </td> <td valign="top"> <paragraph>1</paragraph> </td> <td valign="top"> <paragraph>0.78</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Rectal Pain</paragraph> </td> <td valign="top"> <paragraph>10</paragraph> </td> <td valign="top"> <paragraph>1.23</paragraph> </td> <td valign="top"> <paragraph>0</paragraph> </td> <td valign="top"> <paragraph>0.00</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Constipation</paragraph> </td> <td valign="top"> <paragraph>8</paragraph> </td> <td valign="top"> <paragraph>0.98</paragraph> </td> <td valign="top"> <paragraph>4</paragraph> </td> <td valign="top"> <paragraph>3.12</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Hair Loss</paragraph> </td> <td valign="top"> <paragraph>7</paragraph> </td> <td valign="top"> <paragraph>0.86</paragraph> </td> <td valign="top"> <paragraph>0</paragraph> </td> <td valign="top"> <paragraph>0.00</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Peripheral Edema</paragraph> </td> <td valign="top"> <paragraph>5</paragraph> </td> <td valign="top"> <paragraph>0.61</paragraph> </td> <td valign="top"> <paragraph>11</paragraph> </td> <td valign="top"> <paragraph>8.59</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>UTI/Urinary Burning</paragraph> </td> <td valign="top"> <paragraph>5</paragraph> </td> <td valign="top"> <paragraph>0.61</paragraph> </td> <td valign="top"> <paragraph>4</paragraph> </td> <td valign="top"> <paragraph>3.12</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Rectal Pain/Soreness/Burning</paragraph> </td> <td valign="top"> <paragraph>5</paragraph> </td> <td valign="top"> <paragraph>0.61</paragraph> </td> <td valign="top"> <paragraph>3</paragraph> </td> <td valign="top"> <paragraph>2.34</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Asthenia</paragraph> </td> <td valign="top"> <paragraph>1</paragraph> </td> <td valign="top"> <paragraph>0.12</paragraph> </td> <td valign="top"> <paragraph>4</paragraph> </td> <td valign="top"> <paragraph>3.12</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Insomnia</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>1</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>0.12</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>3</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>2.34</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.