Short answer: In the label's 1-year study against immediate-release risedronate 5 mg daily, the most common Atelvia side effects were diarrhea (8.8% vs 4.9%), influenza (7.2% vs 6.2%), arthralgia (6.8% vs 7.8%), back pain (6.8% vs 5.9%) and abdominal pain (5.2% vs 2.9%). Warnings cover esophagus irritation, low calcium, jaw bone death, severe pain and unusual thigh fractures. There is no boxed warning.
What Atelvia is approved for: Atelvia is a delayed-release form of the bisphosphonate risedronate, the same active ingredient as Actonel. It is approved to treat osteoporosis in postmenopausal women (section 1.1). Its safety and effectiveness rest on one year of clinical data; 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 1.2).
Source
ATELVIA (risedronate sodium) delayed-release tablets, for oral use, prescribing information and Medication Guide. Allergan (AbbVie). DailyMed, version published May 20, 2026. DailyMed setid c8b9ab88-1a26-46c3-80ec-4eaa45202021
No. The current Atelvia 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 Atelvia.
| Adverse reaction | Atelvia 35 mg weekly (N=307) | Risedronate 5 mg immediate-release daily (N=307) |
|---|---|---|
| Diarrhea | 8.8 | 4.9 |
| Abdominal pain | 5.2 | 2.9 |
| Constipation | 4.9 | 2.9 |
| Vomiting | 4.9 | 1.6 |
| Dyspepsia | 3.9 | 3.9 |
| Nausea | 3.6 | 3.9 |
| Abdominal pain upper | 2.9 | 2.3 |
| Influenza | 7.2 | 6.2 |
| Bronchitis | 3.9 | 4.2 |
| Upper respiratory tract infection | 3.6 | 2.6 |
| Arthralgia | 6.8 | 7.8 |
| Back pain | 6.8 | 5.9 |
| Pain in extremity | 3.9 | 2.3 |
| Musculoskeletal pain | 2.0 | 1.6 |
| Muscle spasms | 1.0 | 2.3 |
| Dizziness | 2.6 | 3.3 |
| Headache | 2.6 | 4.9 |
1-year double-blind study in postmenopausal women 50 and older, Atelvia 35 mg once a week taken right after breakfast vs immediate-release risedronate 5 mg daily; there was no placebo group. Values are percent of patients, shown without attribution of causality. All women took calcium and vitamin D.
All-cause deaths were 0.0% on Atelvia and 0.3% on daily risedronate; serious adverse reactions 6.5% vs 7.2%; stopping because of adverse reactions 9.1% vs 8.1%.
Acute phase reaction (flu-like symptoms within 3 days of the first dose): 2.3% on Atelvia vs 1.3% on daily risedronate. Upper digestive reactions overall: 16% vs 15%; stopping because of abdominal pain 1.3% vs 0.7%.
Taking Atelvia before breakfast while fasting gave a significantly higher rate of abdominal pain, which is why it is taken right after breakfast.
At week 52, parathyroid hormone above 65 pg/mL was seen in 9% on Atelvia vs 8% on daily risedronate, and above 97 pg/mL in 2% vs none.
Taken with the PPI esomeprazole, risedronate peak levels rose 60 percent and total exposure 22 percent; the label does not recommend Atelvia with H2 blockers or PPIs.
Reported after approval: allergic and skin reactions including angioedema, Stevens-Johnson syndrome and toxic epidermal necrolysis; esophagus and stomach ulcers; rare severe bone, joint or muscle pain; unusual thigh and other fractures; eye inflammation; 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 with known hypersensitivity to any part of the product.
Same active ingredient. Atelvia has the same active ingredient as Actonel, so a person being treated with Actonel does not also receive Atelvia.
Esophagus and stomach irritation. Oral bisphosphonates can irritate the upper digestive tract; esophagus inflammation, ulcers and erosions, sometimes with bleeding and rarely narrowing or a tear, have been reported. The risk appears greater in people who lie down after a dose, skip the 4 ounces of water, or keep taking it after symptoms start.
Low blood calcium. Low calcium has been reported with Atelvia. Low calcium and other bone mineral problems are treated before starting, and calcium and vitamin D are taken if diet is not enough.
Osteonecrosis of the jaw. Jaw bone death has been reported with bisphosphonates, 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. Atelvia is not recommended when creatinine clearance is under 30 mL/min, because of lack of clinical experience.
From the Medication Guide that comes with Atelvia:
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.