Actonel 35mg Tablets (pack)

Risedronate is a bisphosphonate that inhibits osteoclast-mediated bone resorption. It binds to hydroxyapatite crystals in bone and inhibits the activity of osteoclasts, thereby decreasing the rate of bone turnover and increasing bone mineral density. This leads to a reduction in the incidence of vertebral and non-vertebral fractures.

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Black, tarry, or bloody stools
Chest pain
Coughing up blood
Vomiting blood or material that looks like coffee grounds
Heartburn
Difficulty swallowing
Severe pain when swallowing
Sore throat
New or unusual pain in the groin, hip, or thigh area
Changes in eyesight, eye pain, or severe eye irritation
Trouble urinating
Pain while urinating

Jawbone Problems

This medication may increase the risk of jawbone problems, particularly with long-term use or in people with certain medical conditions, such as cancer, dental problems, or blood clotting disorders. Other factors that may increase the risk include ill-fitting dentures, anemia, infection, dental work, chemotherapy, radiation, or taking other medications that may cause jawbone problems. If you have any concerns or questions, discuss them with your doctor. If you experience jaw swelling or pain, contact your doctor immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild symptoms. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Bone, joint, or muscle pain
Feeling dizzy, tired, or weak
Headache
Flu-like symptoms

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Certain health conditions, including:
+ Esophageal problems
+ Difficulty swallowing
+ Low calcium levels
+ Kidney disease
If you are unable to stand or sit upright for at least 30 minutes
If you are currently taking any of the following medications:
+ Cimetidine
+ Dexlansoprazole
+ Esomeprazole
+ Famotidine
+ Lansoprazole
+ Nizatidine
+ Omeprazole
+ Pantoprazole
+ Rabeprazole
+ Ranitidine
* If you are taking another medication that contains the same active ingredient as this drug

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

This drug can cause severe esophageal problems, such as irritation, swelling, ulcers, and bleeding. Be sure to discuss these potential risks with your doctor.

If you have asthma, you should be aware that medications like this one can worsen asthma symptoms. Consult with your doctor to discuss any concerns.

There is a potential increased risk of fractures, particularly in the legs, associated with this medication. Talk to your doctor about this risk and any measures you can take to minimize it.

As directed by your doctor, have your blood work and bone density checked regularly to monitor any potential effects of this medication.

It is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests.

To maximize the effectiveness of this drug, it is recommended to use it in conjunction with calcium and vitamin D supplements, as well as engage in weight-bearing exercises, such as walking or physical therapy.

Before starting this medication, schedule a dental exam to ensure your teeth and mouth are healthy. Additionally, practice good oral hygiene and visit your dentist regularly for check-ups.

If you plan to consume alcohol, discuss this with your doctor first. Similarly, if you smoke, consult with your doctor about the potential risks and benefits of continuing to smoke while taking this medication.

A rare but severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can cause severe health problems, permanent damage, and even death. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin, with or without fever, red or irritated eyes, or sores in your mouth, throat, nose, or eyes.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.

• Antacids (calcium, magnesium, aluminum-containing): Significantly reduce risedronate absorption.
• Calcium supplements: Significantly reduce risedronate absorption.
• Iron supplements: Significantly reduce risedronate absorption.
• Magnesium supplements: Significantly reduce risedronate absorption.

• NSAIDs (Nonsteroidal Anti-inflammatory Drugs): Concurrent use may increase the risk of gastrointestinal irritation/ulcers.
• H2-receptor antagonists/Proton pump inhibitors: May increase gastric pH, potentially affecting risedronate absorption, though clinical significance is debated.

• Dysphagia
• Esophagitis
• Esophageal ulceration
• Chest pain
• Heartburn (new or worsening)
• Difficulty swallowing
• Severe musculoskeletal pain
• Jaw pain or swelling
• Numbness or heavy sensation in the jaw
• Unusual thigh, hip, or groin pain (potential atypical femoral fracture)

Risedronate is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Bisphosphonates are incorporated into the bone matrix and are gradually released over years. The extent of fetal exposure is unknown.

It is not known whether risedronate is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants from bisphosphonates, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients. Use is not recommended.

No overall differences in efficacy or safety were observed between elderly and younger patients. No dosage adjustment is necessary based on age alone, but renal function should be monitored as elderly patients are more likely to have decreased renal function.

• Patient adherence to dosing instructions (taking with plain water, remaining upright, avoiding food/other meds) is crucial for efficacy and to minimize esophageal adverse events.
• Ensure patients have adequate calcium and vitamin D intake, as these are essential for bone health and to prevent hypocalcemia.
• Consider a 'drug holiday' after 3-5 years of bisphosphonate therapy in low-risk patients to reduce the risk of rare but serious adverse events like ONJ and atypical femoral fractures, after discussion with the patient.
• Educate patients on symptoms of esophageal irritation (chest pain, dysphagia, worsening heartburn) and atypical femoral fractures (new thigh/groin pain) and to report them immediately.
• A dental examination should be considered prior to initiating bisphosphonate therapy, especially in patients with risk factors for osteonecrosis of the jaw (e.g., cancer, chemotherapy, corticosteroids, poor oral hygiene).

• Other oral bisphosphonates (e.g., Alendronate, Ibandronate)
• Intravenous bisphosphonates (e.g., Zoledronic acid)
• Denosumab (Prolia)
• Teriparatide (Forteo)
• Abaloparatide (Tymlos)
• Romosozumab (Evenity)
• Selective Estrogen Receptor Modulators (SERMs) (e.g., Raloxifene)
• Calcitonin

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.