Arestin Side Effects
Please note - some side effects for Arestin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Arestin - for the consumer
Arestin Microspheres
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Arestin Microspheres:
Seek medical attention right away if any of these SEVERE side effects occur when using Arestin Microspheres:Flu-like symptoms; headache; stomach upset.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding or discharge from the gums; fever; pain, redness, itching, or swelling of the gums or mouth; painful sores in the mouth; severe diarrhea; severe or persistent headache; stomach pain or cramps.
For the professional
Arestin
The most frequently reported nondental treatment-emergent adverse events in the 3 multicenter US trials were headache, infection, flu syndrome, and pain.
| SRP Alone N=250 |
SRP + Vehicle N=249 |
SRP + Arestin N=423 |
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| Number (%) of Patients Treatment-emergent AEs |
62.4% | 71.9% | 68.1% |
| Total Number of AEs | 543 | 589 | 987 |
| Periodontitis | 25.6% | 28.1% | 16.3% |
| Tooth Disorder | 12.0% | 13.7% | 12.3% |
| Tooth Caries | 9.2% | 11.2% | 9.9% |
| Dental Pain | 8.8% | 8.8% | 9.9% |
| Gingivitis | 7.2% | 8.8% | 9.2% |
| Headache | 7.2% | 11.6% | 9.0% |
| Infection | 8.0% | 9.6% | 7.6% |
| Stomatitis | 8.4% | 6.8% | 6.4% |
| Mouth Ulceration | 1.6% | 3.2% | 5.0% |
| Flu Syndrome | 3.2% | 6.4% | 5.0% |
| Pharyngitis | 3.2% | 1.6% | 4.3% |
| Pain | 4.0% | 1.2% | 4.3% |
| Dyspepsia | 2.0% | 0 | 4.0% |
| Infection Dental | 4.0% | 3.6% | 3.8% |
| Mucous Membrane Disorder | 2.4% | 0.8% | 3.3% |
The change in clinical attachment levels was similar across all study arms, suggesting that neither the vehicle nor Arestin compromise clinical attachment.
TopMore resources:
Arestin Dental - Includes detailed dosage instructions.
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