Note: This document contains side effect information about risedronate. Some dosage forms listed on this page may not apply to the brand name Atelvia.

Applies to risedronate: oral tablet, oral tablet delayed release.

Serious side effects of Atelvia

Along with its needed effects, risedronate (the active ingredient contained in Atelvia) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking risedronate:

More common

• Abdominal or stomach pain
• skin rash

Less common

• Abdominal or stomach pain (severe)
• belching
• bone pain
• cramping of the stomach
• trouble swallowing

Rare

• Red, sore eyes

Incidence not known

• Bone, joint, or muscle pain, severe and occasionally incapacitating
• chest pain
• heartburn
• pain or burning in the throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur while taking risedronate:

Symptoms of overdose

• Confusion
• convulsions
• difficulty with breathing
• irregular heartbeats
• muscle cramps in the hands, arms, feet, legs, or face
• numbness and tingling around the mouth, fingertips, or feet
• shortness of breath
• tremor

Other side effects of Atelvia

Some side effects of risedronate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• cough or hoarseness
• diarrhea
• fever or chills
• headache
• joint pain
• lower back or side pain
• painful or difficult urination

Less common

• Acid or sour stomach
• bladder pain
• bloody or cloudy urine
• blurred vision or change in vision
• body aches or pains
• congestion
• constipation
• difficult, burning, or painful urination
• difficulty with moving
• dizziness
• dry eyes
• dryness or soreness of the throat
• frequent urge to urinate
• general feeling of discomfort or illness
• indigestion
• leg cramps
• muscle pain or stiffness
• nausea
• nervousness
• pain, swelling, or redness in the joints
• pounding in the ears
• ringing in the ears
• runny nose
• slow or fast heartbeat
• stomach discomfort or upset
• swelling of the feet or lower legs
• tender swollen glands in the neck
• voice changes
• weakness

Rare

• Fainting
• fear
• itching skin
• loss of appetite
• pale skin
• passing of gas
• redness, swelling, or soreness of the tongue
• sneezing
• stomach fullness
• tightness in the chest
• troubled breathing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• wheezing

Incidence not known

• Eye pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle pain
• redness of the eye
• sensitivity of the eye to light
• skin blisters
• tearing

For Healthcare Professionals

Applies to risedronate: oral delayed release tablet, oral tablet.

General

Abdominal and musculoskeletal pain were commonly reported adverse effects.^[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 10.5%)

Common (1% to 10%): Arrhythmia (2%) in men with osteoporosis

Frequency not reported: Syncope, vasodilation^[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 12.9%), diarrhea (up to 10.8%), dyspepsia (up to 10.8%), nausea (up to 10.5%)

Common (1% to 10%): Abdominal pain, vomiting, abdominal upper pain, gastritis, gastroesophageal reflux disease, gastroenteritis

Uncommon (0.1% to 1%): Duodenitis, glossitis

Rare (less than 0.1%): Esophageal stricture

Postmarketing reports: Esophagitis, esophageal or gastric ulcers^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 11.1%)

Common (1% to 10%): Nocturia (1.6%), cystitis, hemorrhoids, Hiatus hernia, urinary disorders, reproductive system and breast disorders^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 23.7%)

Common (1% to 10%): Back pain, pain in extremity, musculoskeletal pain, bone pain, muscle spasms, myalgia, neck pain, arthritis, traumatic bone fracture, join disorder, leg cramps, myasthenia (1.6%), osteoarthritis, tendonitis

Rare (less than 0.1%): Severe or incapacitating bone, join, or muscle pain; osteonecrosis of the jaw (ONJ); atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)

Frequency not reported: Muscle spasms^[Ref]

Other

Very common (10% or more): Accidental injury (up to 16.9%), pain (up to 14.1%), flu syndrome (up to 11.6%)

Common (1% to 10%): Tinnitus (1.6%), asthenia, peripheral edema, contusion, herpes zoster (1% to 2.6%), ear and labyrinth disorders, vertigo^[Ref]

Respiratory

Very common (10% or more): Bronchitis (up to 10%)

Common (1% to 10%): Influenza, upper respiratory infection, chest pain, sinusitis, rhinitis, pharyngitis, increased cough, apnea (1.6%)

Postmarketing reports: Asthma exacerbations^[Ref]

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Pruritus^[Ref]

Endocrine

Common (1% to 10%): Elevated levels of parathyroid hormone (PTH), endocrine disorders^[Ref]

Hematologic

Common (1% to 10%): Anemia (1% to 2.6%), blood and lymphatic system disorders^[Ref]

Hepatic

In most of the postmarketing reported cases the patients were also treated with other products known to cause hepatic disorders.^[Ref]

Common (1% to 10%): Colitis (1.6%), hepatobiliary disorders

Rare (less than 0.1%): Abnormal liver function test

Postmarketing reports: Serious hepatic disorders^[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reactions

Postmarketing reports: Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis, anaphylactic reactions^[Ref]

Immunologic

Common (1% to 10%): Immune system disorders^[Ref]

Metabolic

Transient decreases from baseline in serum calcium (less than 1%) and serum phosphate (less than 3%) were observed within 6 months in patients in osteoporosis clinical trials treated with doses of 5 mg daily immediate-release.^[Ref]

Common (1% to 10%): Decreased weight, hypocalcemia (1.6%), transient decreases from baseline of serum calcium and phosphate, hypercholesterolemia^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, insomnia, sciatica (0.6% to 2.3%)^[Ref]

Ocular

Common (1% to 10%): Cataract; amblyopia, corneal lesion and dry eye (1.6%)

Uncommon (0.1% to 1%): Iritis

Rare (less than 0.1%): Eye inflammation including uveitis^[Ref]

Oncologic

Common (1% to 10%): Benign prostatic hyperplasia (5%) in men with osteoporosis; neoplasms benign, malignant and unspecified (including cysts and polyps)^[Ref]

Psychiatric

Common (1% to 10%): Depression, psychiatric disorders^[Ref]

Renal

Common (1% to 10%): Nephrolithiasis (3%) in men with osteoporosis, renal disorders^[Ref]