Short answer: The Actonel label lists back pain, joint pain (arthralgia), abdominal pain and dyspepsia as the most common side effects, each over 10% and higher than placebo. In the 3-year treatment trials, back pain was 28.0% on Actonel 5 mg vs 26.1% on placebo and abdominal pain 12.2% vs 9.9%. Warnings cover esophagus irritation, low calcium, jaw bone death and unusual thigh fractures. There is no boxed warning.
What Actonel is approved for: Actonel is a bisphosphonate approved to treat and prevent osteoporosis in postmenopausal women, to increase bone mass in men with osteoporosis, to treat and prevent steroid (glucocorticoid)-induced osteoporosis in people taking 7.5 mg or more of prednisone or equivalent a day, and to treat Paget's disease of bone (sections 1.1 to 1.4). The best length of use has not been set, and people at low fracture risk may be considered for stopping after 3 to 5 years (section 1.5).
Source
ACTONEL (risedronate sodium) tablets, for oral use, prescribing information and Medication Guide. Allergan (AbbVie). DailyMed, version published May 11, 2026. DailyMed setid 24ed00e0-25e2-49a8-97fc-66c1b417dc0b
No. The current Actonel label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Actonel.
| Adverse event | Placebo (N=1619) | Actonel 5 mg (N=1613) |
|---|---|---|
| Infection | 29.9 | 31.1 |
| Back pain | 26.1 | 28.0 |
| Arthralgia | 22.1 | 23.7 |
| Accidental injury | 16.8 | 16.9 |
| Constipation | 12.6 | 12.9 |
| Abdominal pain | 9.9 | 12.2 |
| Urinary tract infection | 10.4 | 11.1 |
| Diarrhea | 10.0 | 10.8 |
| Dyspepsia | 10.6 | 10.8 |
| Hypertension | 9.8 | 10.5 |
| Nausea | 11.2 | 10.5 |
| Headache | 10.8 | 9.9 |
| Rash | 7.1 | 7.9 |
| Dizziness | 5.7 | 7.1 |
| Joint disorder | 5.3 | 7.0 |
| Myalgia | 6.2 | 6.7 |
| Bone pain | 4.8 | 5.3 |
Four placebo-controlled trials of up to 3 years in 3232 women. Values are percent of patients, shown without attribution of causality. All-cause deaths were 2.0% on placebo and 1.7% on Actonel; stopping because of adverse events was 15.6% vs 14.8%.
| Adverse event | Actonel 30 mg/day x 2 months (N=61) | Didronel 400 mg/day x 6 months (N=61) |
|---|---|---|
| Flu syndrome | 9.8 | 1.6 |
| Chest pain | 6.6 | 3.3 |
| Diarrhea | 19.7 | 14.8 |
| Abdominal pain | 11.5 | 8.2 |
| Nausea | 9.8 | 9.8 |
| Constipation | 6.6 | 8.2 |
| Peripheral edema | 8.2 | 6.6 |
| Arthralgia | 32.8 | 29.5 |
| Headache | 18.0 | 16.4 |
| Dizziness | 6.6 | 4.9 |
| Rash | 11.5 | 8.2 |
Actonel 30 mg a day for 2 months compared with Didronel (etidronate) 400 mg a day for 6 months. Values are percent of patients; events were considered possibly or probably related in at least one patient.
Weekly 35 mg vs daily 5 mg (1 year): dyspepsia 7.6% vs 6.9%, abdominal pain 7.6% vs 7.3%, arthralgia 14.2% vs 11.5%, myalgia 6.2% vs 4.6%. The label says the two had similar safety.
Acute phase reaction (flu-like symptoms after the first dose): 7.6% on 75 mg two days a month vs 3.6% on 5 mg daily, and 5.2% on 150 mg monthly vs 1.1% on 5 mg daily.
Diarrhea was 8.2% on 150 mg monthly vs 4.7% on 5 mg daily. Low calcium at the end of the first month was 4.5% on 75 mg two days a month vs 3.0% on daily dosing, then about 2% on both.
Men with osteoporosis (35 mg weekly, 2 years): benign prostatic hyperplasia 5% vs 3% on placebo, kidney stones 3% vs 0%, arrhythmia 2% vs 0%.
Steroid-induced osteoporosis (5 mg daily, 1 year): back pain 17.8% vs 8.8% on placebo, arthralgia 24.7% vs 14.7%.
Reported after approval: allergic and skin reactions including angioedema, Stevens-Johnson syndrome and toxic epidermal necrolysis; esophagitis and esophageal or stomach ulcers; rare severe bone, joint or muscle pain; unusual thigh and other fractures; eye inflammation (iritis, uveitis); jaw osteonecrosis; and asthma flare-ups.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. People with esophagus problems that slow emptying, such as a narrowing or achalasia; people who cannot stand or sit upright for at least 30 minutes; people with low blood calcium; and anyone allergic to Actonel or its ingredients.
Same active ingredient. Actonel has the same active ingredient as Atelvia, so a person taking Atelvia does not also take Actonel.
Esophagus and stomach irritation. Actonel can irritate the upper digestive tract. Esophagus inflammation, ulcers and erosions, sometimes with bleeding and rarely narrowing or a tear, have been reported with oral bisphosphonates. The risk appears greater in people who lie down after a dose, skip the full glass of water, or keep taking it after symptoms start. It is stopped for trouble or pain swallowing, chest pain or new or worse heartburn.
Low blood calcium. Low calcium and other bone mineral problems are treated before starting. Calcium and vitamin D are taken if diet is not enough, especially in Paget's disease.
Osteonecrosis of the jaw. Jaw bone death has been reported, usually with tooth extraction or local infection with slow healing. Risk factors include invasive dental work, cancer, chemotherapy, steroids and poor mouth care, and the risk may grow with longer use.
Bone, joint and muscle pain. Severe, sometimes disabling pain has been reported, starting from one day to several months after starting. Most people improved after stopping, and stopping is considered if severe symptoms develop.
Unusual thigh and other fractures. Low-trauma fractures of the thigh bone shaft and other bones have been reported, sometimes on both sides, often after weeks to months of dull, aching thigh pain. New thigh or groin pain is checked for a fracture, and pausing the bisphosphonate is considered.
Kidney impairment. Actonel is not recommended when creatinine clearance is under 30 mL/min.
From the Medication Guide that comes with Actonel:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.