Home FDA labels 7513d082-baad-4623-9944-56efa7e2517f FDA label 7513d082-baad-4623-9944-56efa7e2517f 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 34a30bb0-143b-4624-a8ee-f88c2aefa470
SPL ID 7513d082-baad-4623-9944-56efa7e2517f
Version 5
Effective date 2013-02-04
Source export date 2026-10-12
Source partition 6
Source file https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:49:47 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
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warnings WARNINGS Mesalamine rectal suspension 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.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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adverse reactions ADVERSE REACTIONS Clinical Adverse Experience Mesalamine rectal suspension is usually well tolerated. Most adverse effects have been mild and transient. ADVERSE REACTIONS OCCURRING IN MORE THAN 0.1% OF MESALAMINE RECTAL SUSPENSION TREATED PATIENTS (COMPARISON TO PLACEBO) SYMPTOM MESALAMINE N = 815 N % PLACEBO N = 128 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 postmarketing 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 or sulfasalazine. Retreatment is not always associated with repeated hair loss.
adverse reactions table <table border="1" width="427" ID="id_8a7adc09-0b37-468e-9656-947bb183cea1"> <caption ID="id_b0ae8430-c452-46ab-975e-1d4669bfebcb">ADVERSE REACTIONS OCCURRING IN MORE THAN 0.1% OF MESALAMINE RECTAL SUSPENSION TREATED PATIENTS (COMPARISON TO PLACEBO)</caption> <col width="48.0%"/> <col width="12.2%"/> <col width="15.2%"/> <col width="13.8%"/> <col width="10.8%"/> <tbody> <tr ID="id_4f9bc9e7-487b-4710-9d03-aa5a779c66ca"> <td align="left" valign="middle" styleCode="Botrule Toprule Rrule Lrule"> <content styleCode="bold">SYMPTOM</content> </td> <td align="center" valign="middle" styleCode="Botrule Rrule"> <content styleCode="bold">MESALAMINE </content> <content styleCode="bold">N = 815 N</content> </td> <td align="center" valign="middle" styleCode="Botrule Rrule"> <content styleCode="bold">%</content> </td> <td align="center" valign="middle" styleCode="Botrule Rrule"> <content styleCode="bold">PLACEBO</content> <content styleCode="bold">N = 128 N</content> </td> <td align="center" valign="middle" styleCode="Botrule Rrule"> <content styleCode="bold"> </content> <content styleCode="bold">%</content> </td> </tr> <tr ID="id_faa508fa-4194-4722-8311-3953e4e3663e"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Abdominal Pain/Cramps/Discomfort</td> <td align="center" valign="middle" styleCode="Botrule Rrule">66</td> <td align="center" valign="middle" styleCode="Botrule Rrule">8.10</td> <td align="center" valign="middle" styleCode="Botrule Rrule">10</td> <td align="center" valign="middle" styleCode="Botrule Rrule">7.81</td> </tr> <tr ID="id_7439aa06-07f4-4b7d-bfbc-4817bc970f17"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Headache</td> <td align="center" valign="middle" styleCode="Botrule Rrule">53</td> <td align="center" valign="middle" styleCode="Botrule Rrule">6.50</td> <td align="center" valign="middle" styleCode="Botrule Rrule">16</td> <td align="center" valign="middle" styleCode="Botrule Rrule">12.50</td> </tr> <tr ID="id_a010edec-73c2-40f0-bdb0-7351f6f75026"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Gas/Flatulence</td> <td align="center" valign="middle" styleCode="Botrule Rrule">50</td> <td align="center" valign="middle" styleCode="Botrule Rrule">6.13</td> <td align="center" valign="middle" styleCode="Botrule Rrule">5</td> <td align="center" valign="middle" styleCode="Botrule Rrule">3.91</td> </tr> <tr ID="id_d310e746-bad4-4a7c-ad3b-6c90a356a3b0"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Nausea</td> <td align="center" valign="middle" styleCode="Botrule Rrule">47</td> <td align="center" valign="middle" styleCode="Botrule Rrule">5.77</td> <td align="center" valign="middle" styleCode="Botrule Rrule">12</td> <td align="center" valign="middle" styleCode="Botrule Rrule">9.38</td> </tr> <tr ID="id_35878534-7a4d-44c5-bf73-2b44ee264c8e"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Flu</td> <td align="center" valign="middle" styleCode="Botrule Rrule">43</td> <td align="center" valign="middle" styleCode="Botrule Rrule">5.28</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.78</td> </tr> <tr ID="id_6b263548-6f25-4366-bb93-1e6df04d1be4"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Tired/Weak/Malaise/Fatigue</td> <td align="center" valign="middle" styleCode="Botrule Rrule">28</td> <td align="center" valign="middle" styleCode="Botrule Rrule">3.44</td> <td align="center" valign="middle" styleCode="Botrule Rrule">8</td> <td align="center" valign="middle" styleCode="Botrule Rrule">6.25</td> </tr> <tr ID="id_fa662c91-7964-4d3a-bb19-74fd8edd2d37"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Fever</td> <td align="center" valign="middle" styleCode="Botrule Rrule">26</td> <td align="center" valign="middle" styleCode="Botrule Rrule">3.19</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.00</td> </tr> <tr ID="id_9fd0a8e6-7003-4a40-95ca-335f228f6551"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Rash/Spots</td> <td align="center" valign="middle" styleCode="Botrule Rrule">23</td> <td align="center" valign="middle" styleCode="Botrule Rrule">2.82</td> <td align="center" valign="middle" styleCode="Botrule Rrule">4</td> <td align="center" valign="middle" styleCode="Botrule Rrule">3.12</td> </tr> <tr ID="id_f3d4c2c6-d97b-4abb-a8ad-446cc5350f88"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Cold/Sore Throat</td> <td align="center" valign="middle" styleCode="Botrule Rrule">19</td> <td align="center" valign="middle" styleCode="Botrule Rrule">2.33</td> <td align="center" valign="middle" styleCode="Botrule Rrule">9</td> <td align="center" valign="middle" styleCode="Botrule Rrule">7.03</td> </tr> <tr ID="id_dba9a219-0f19-45ea-81cc-39c1b6202b52"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Diarrhea</td> <td align="center" valign="middle" styleCode="Botrule Rrule">17</td> <td align="center" valign="middle" styleCode="Botrule Rrule">2.09</td> <td align="center" valign="middle" styleCode="Botrule Rrule">5</td> <td align="center" valign="middle" styleCode="Botrule Rrule">3.91</td> </tr> <tr ID="id_f8841e42-23a6-4759-877c-6da6747458c6"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Leg/Joint Pain</td> <td align="center" valign="middle" styleCode="Botrule Rrule">17</td> <td align="center" valign="middle" styleCode="Botrule Rrule">2.09</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.78</td> </tr> <tr ID="id_df6e9679-d845-49f1-baf1-c296301fc317"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Dizziness</td> <td align="center" valign="middle" styleCode="Botrule Rrule">15</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1.84</td> <td align="center" valign="middle" styleCode="Botrule Rrule">3</td> <td align="center" valign="middle" styleCode="Botrule Rrule">2.34</td> </tr> <tr ID="id_3bf466b0-39f4-4880-8565-404e0ec40040"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Bloating</td> <td align="center" valign="middle" styleCode="Botrule Rrule">12</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1.47</td> <td align="center" valign="middle" styleCode="Botrule Rrule">2</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1.56</td> </tr> <tr ID="id_cfc4b47b-c48b-4788-a14e-c32e60be128d"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Back Pain</td> <td align="center" valign="middle" styleCode="Botrule Rrule">11</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1.35</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.78</td> </tr> <tr ID="id_5a948828-d7a1-4acc-89cc-8befe73ad3ee"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Pain on Insertion of Enema Tip</td> <td align="center" valign="middle" styleCode="Botrule Rrule">11</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1.35</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.78</td> </tr> <tr ID="id_6a8212cf-eae0-4dc2-9948-d285b927cad8"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Hemorrhoids</td> <td align="center" valign="middle" styleCode="Botrule Rrule">11</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1.35</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.00</td> </tr> <tr ID="id_1908277b-012b-43d3-9d3b-985b9f0f5638"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Itching</td> <td align="center" valign="middle" styleCode="Botrule Rrule">10</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1.23</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.78</td> </tr> <tr ID="id_629f21bf-fcb5-4518-b88c-eb852f8f0c30"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Rectal Pain</td> <td align="center" valign="middle" styleCode="Botrule Rrule">10</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1.23</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.00</td> </tr> <tr ID="id_4c99922c-d5d1-48e5-aa24-bce5a28ab39f"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Constipation</td> <td align="center" valign="middle" styleCode="Botrule Rrule">8</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.98</td> <td align="center" valign="middle" styleCode="Botrule Rrule">4</td> <td align="center" valign="middle" styleCode="Botrule Rrule">3.12</td> </tr> <tr ID="id_9f316111-4b33-4e77-93d0-d9a8192da9fc"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Hair Loss</td> <td align="center" valign="middle" styleCode="Botrule Rrule">7</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.86</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.00</td> </tr> <tr ID="id_faf8fd2f-1174-4c9f-a27c-0e1a656f294a"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Peripheral Edema</td> <td align="center" valign="middle" styleCode="Botrule Rrule">5</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.61</td> <td align="center" valign="middle" styleCode="Botrule Rrule">11</td> <td align="center" valign="middle" styleCode="Botrule Rrule">8.59</td> </tr> <tr ID="id_6f953da3-0e58-463e-9fb6-c61f19d19995"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">UTI/Urinary Burning</td> <td align="center" valign="middle" styleCode="Botrule Rrule">5</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.61</td> <td align="center" valign="middle" styleCode="Botrule Rrule">4</td> <td align="center" valign="middle" styleCode="Botrule Rrule">3.12</td> </tr> <tr ID="id_bab824db-70c9-490e-a7c9-98438d1b51f2"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Rectal Pain/Soreness/Burning</td> <td align="center" valign="middle" styleCode="Botrule Rrule">5</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.61</td> <td align="center" valign="middle" styleCode="Botrule Rrule">3</td> <td align="center" valign="middle" styleCode="Botrule Rrule">2.34</td> </tr> <tr ID="id_b15c0712-6196-45fb-8b04-128f6d71d85f"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Asthenia</td> <td align="center" valign="middle" styleCode="Botrule Rrule">1</td> <td align="center" valign="middle" styleCode="Botrule Rrule">0.12</td> <td align="center" valign="middle" styleCode="Botrule Rrule">4</td> <td align="center" valign="middle" styleCode="Botrule Rrule">3.12</td> </tr> <tr ID="id_9696d42f-a0e2-4ef7-b584-42ba7e787566"> <td align="left" valign="middle" styleCode="Lrule Botrule Rrule">Insomnia</td> <td align="center" valign="middle" styleCode="Rrule">1</td> <td align="center" valign="middle" styleCode="Rrule">0.12</td> <td align="center" valign="middle" styleCode="Rrule">3</td> <td align="center" valign="middle" styleCode="Botrule Rrule">2.34</td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.