What are the most common side effects of DENOSUMAB?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for DENOSUMAB. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is DENOSUMAB the same as CONEXXENCE?

CONEXXENCE is a brand name for DENOSUMAB. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

DENOSUMAB

Q: What is DENOSUMAB used for?

DENOSUMAB (brand name CONEXXENCE) is a RANKL Inhibitor indicated for defined as a history of osteoporotic fracture, or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis.

Q: How does DENOSUMAB work?

DENOSUMAB works through the following mechanism: 12.1 Mechanism of Action Denosumab products bind to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab products prevent RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone..

RANKL Inhibitor

Brand names: CONEXXENCE, Prolia, Xgeva

Subcutaneous

Mechanism of Action

12.1 Mechanism of Action Denosumab products bind to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab products prevent RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.

Indications

defined as a history of osteoporotic fracture

or multiple risk factors for fracture

or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis

denosumab reduces the incidence of vertebral

nonvertebral

defined as a history of osteoporotic fracture

Contraindications

• facial swelling
• and urticaria [see Warnings and Precautions ( 5.3 )
• Adverse Reactions ( 6.2 )] . Hypocalcemia ( 4
• 5.1 ) Pregnancy ( 4
• 8.1 ) Known hypersensitivity to denosumab products ( 4

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating Conexxence
Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk
6 ) Serious infections including skin infections: May occur, including those leading to hospitalization
1 Severe Hypocalcemia and Mineral Metabolism Changes Denosumab products can cause severe hypocalcemia and fatal cases have been reported

Known Side Effects

10 documented side effects by frequency

Joint Pain

1-10%

Fatigue

1-10%

Limb Pain

1-10%

Back Pain

1-10%

Nausea

0.1-1%

Diarrhea

0.1-1%

Falls

0.1-1%

Rash

0.1-1%

Muscle Pain

0.1-1%

Weakness

0.1-1%

Community Discussions

7 Reddit threads analysed for DENOSUMAB

Overall Sentiment

Mixed

Comparison Threads

Avg Post Score

3 upvotes

Most discussed side effects in community

Anxiety (2)

Nausea (1)

Diarrhea (1)

Fatigue (1)

Stomach Pain (1)

Patient Experiences (r/pharmacy, r/AskDocs & more)

Questions about tumor removal & spinal fusion surgery scheduled for next week - C7toT3 (ish?)

(Caucasian Female, 28,168 cm, 58kg, no other conditions) I have recently been diagnosed with a Giant Cell Tumor that essentially took out my T2. To avoid permanent damage to the spinal cord, doctors are planning to operate next week, taking out the tumor and fusing C7 through T3. Are there any alter

r/AskDocs8111y ago

My mother has osteoporosis and is scared of having another DEXA scan

* Age - 79 * Sex - female * Height - 4'8" * Weight - 65kg * Race - white * Duration of complaint - 10 years + * Location (Geographic and on body) - spine * Any existing relevant medical issues (if any) - osteoporosis * Current medications (if any) - codeine, Prolia (denosumab), Adcal (vit d and calc

r/AskDocs413y ago

Anxiety

62 yo female, 5'2", 104 lbs, rising amylase and lipase - worried about pancreatic cancer

Hello, any advise/input would be helpful and greatly appreciated! I received worrisome labs on Friday. I am a 62-year-old Caucasian female, 5'2", 104lbs, with a history of osteoporosis, diverticulitis (resection done 6 years ago), and anxiety. Current medications include Zoloft 25 mg daily, and I a

r/AskDocs342y ago

Nausea

Diarrhea

Fatigue

Giant Cell Tumor of Soft Tissue

The patient in question is a 23 year old white male. 5'8, 200lbs. Patient began having trouble with his left leg in November of 2015. He was diagnosed with a Giant Cell Tumor of the Bone in his tibia. He underwent surgery to remove it. By May of 2016, the tumor had recurred and the patient had anoth

r/AskDocs207y ago

My 79 year old mothers body temp was 35c, on checking again 35.6c, should I be worried?

* Age - 79 * Sex - female * Height - 4'8" * Weight - 65kg * Race - white * Duration of complaint - one week, she's mentioned low temp and I didn't pick up on it a few days back * Location (Geographic and on body) - spine * Any existing relevant medical issues (if any) - osteoporosis * Current medi

r/AskDocs113y ago

Chromogranin A

Hi! Can someone tell me if I should be worried about my mom labs? Today I found out she has Chromogranin A at 104 ng/ml (lab says normal is less than 100) She has no symptoms at all! Information: 54 years old Female She has osteoarthritis, osteoporosis and hyperlipidemia (controlled), for what s

r/AskDocs111y ago

Punch Biopsy Accuracy

Age 36 Male 260 lbs Never a smoker Barely drink So, long story short - back in Oct 2019 I had a punch biopsy into my sacrum for suspected cancer, but it came back inconclusive, so it was repeated and was then confirmed to be a Giant Cell Tumor. I recently had an operation to remove the tumor via

r/AskDocs115y ago

Community discussions are sourced from public Reddit threads. Content reflects individual opinions and is not medical advice.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → DENOSUMAB openFDA label JSON → DENOSUMAB FAERS adverse-event reports → DENOSUMAB ClinicalTrials.gov → completed Phase 2+ trials of DENOSUMAB

Compare With

7 available comparisons

Formulations

Dosage Forms

Tablet

Route

Subcutaneous