What the label lists and what reports show
Risedronate side effects
Risedronate's FDA label: “Most common adverse reactions reported in greater than 10% of patients treated with Risedronate Sodium and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia ( 6.1 ) Hypersensitivity reactions (angioedema …” FAERS holds 30,906 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is arthralgia (3,876 reports).
- Generic listed
Check it at the source: the risedronate FDA label on DailyMed (effective February 12, 2026, Mylan Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Risedronate Sodium ?Risedronate Sodium may cause serious side effects: See “What is the most important information I should know about Risedronate Sodium ?” The most common side effects of Risedronate Sodium are: pain, including back and joint pain stomach area (abdominal) pain heartburn You may get allergic reactions, such as hives, swelling of your face, lips, tongue, or throat. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Risedronate Sodium. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, NDA020835 (Apil), as published by Mylan Pharmaceuticals, Inc., effective February 12, 2026 (SPL set f715718a-407d-4e2a-9834-74a8f1361d03), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions reported in greater than 10% of patients treated with Risedronate Sodium and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia ( 6.1 ) Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely
Table 1 Adverse Events Occurring at a Frequency greater than or equal to 5% in Either…
| Body System | Placebo N = 1619 % | 5 mg Risedronate Sodium N = 1613 % |
|---|---|---|
| Infection | 29.9 | 31.1 |
| Back Pain | 26.1 | 28.0 |
| Accidental Injury | 16.8 | 16.9 |
| Pain | 14.0 | 14.1 |
| Abdominal Pain | 9.9 | 12.2 |
| Flu Syndrome | 11.6 | 10.5 |
| Headache | 10.8 | 9.9 |
| Asthenia | 4.5 | 5.4 |
| Neck Pain | 4.7 | 5.4 |
| Chest Pain | 5.1 | 5.0 |
| Allergic Reaction | 5.9 | 3.8 |
| Hypertension | 9.8 | 10.5 |
| Constipation | 12.6 | 12.9 |
| Diarrhea | 10.0 | 10.8 |
| Dyspepsia | 10.6 | 10.8 |
| Nausea | 11.2 | 10.5 |
| Peripheral Edema | 8.8 | 7.7 |
| Arthralgia | 22.1 | 23.7 |
| Arthritis | 10.1 | 9.6 |
| Traumatic Bone Fracture | 12.3 | 9.3 |
| Joint Disorder | 5.3 | 7.0 |
| Myalgia | 6.2 | 6.7 |
| Bone Pain | 4.8 | 5.3 |
| Dizziness | 5.7 | 7.1 |
| Depression | 6.1 | 6.8 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse drug reactions are described elsewhere in the labeling: Drug Products with the Same Active Ingredient [see Warnings and Precautions (5.1) ] Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.2) ] Mineral Metabolism [see Warnings and Precautions (5.3) ] Jaw Osteonecrosis [see Warnings and Precautions (5.4) ] Musculoskeletal Pain [see Warnings and Precautions (5.5) ] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions (5.6) ] Renal Impairment [see Warnings and Precautions (5.7) ] Glucocorticoid-Induced Osteoporosis [see Warnings and Precautions (5.8) ] Laboratory Test Interactions [see Warnings and Precautions (5.9) ] Most common adverse reactions reported in greater than 10% of patients treated with Risedronate Sodium and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia ( 6.1 ) Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, NDA020835 (Apil), as published by Mylan Pharmaceuticals, Inc., effective February 12, 2026 (SPL set f715718a-407d-4e2a-9834-74a8f1361d03), via openFDA; the full label on DailyMed
What do FAERS reports show?
30,906 reports list risedronate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,904 are coded as a death and 12,402 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Risedronate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions