What the label lists and what reports show
Romosozumab side effects
Romosozumab's FDA label: “The most common adverse reactions (≥ 5%) reported with EVENITY in clinical trials were arthralgia and headache.” FAERS holds 13,496 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fall (795 reports).
- No generic listed
- Boxed warning
Check it at the source: the romosozumab FDA label on DailyMed (effective July 16, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of EVENITY ?EVENITY may cause serious side effects, including: See “What is the most important information I should know about EVENITY ?” Serious allergic reactions. Serious allergic reactions have happened in people who receive EVENITY. Call your healthcare provider or go to the nearest emergency room right away if you have any symptoms of a serious allergic reaction. Symptoms of a serious allergic reaction may include: ○ rash ○ hives ○ swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing or breathing Low calcium levels in your blood (hypocalcemia). EVENITY may lower the calcium levels in your blood. Your low blood calcium should be treated before you receive EVENITY. […]
Source: FDA drug label, Amgen, Inc, effective July 16, 2026 (SPL set 471baba2-7154-4488-9891-0db2f46791e7), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 5%) reported with EVENITY in clinical trials were arthralgia and headache.
Table 1. Adverse Reactions Occurring in ≥ 2% of EVENITY-Treated Women in at Least One Study (Studies 1 and 2)
| Preferred Term | Placebo (N = 3576) n (%) | EVENITY (N = 3581) n (%) | Alendronate (N = 2014) n (%) | EVENITY (N = 2040) n (%) |
|---|---|---|---|---|
| Arthralgia | 434 (12.1) | 468 (13.1) | 194 (9.6) | 166 (8.1) |
| Headache | 208 (5.8) | 235 (6.6) | 110 (5.5) | 106 (5.2) |
| Muscle spasms | 140 (3.9) | 163 (4.6) | 81 (4.0) | 70 (3.4) |
| Edema peripheral | 67 (1.9) | 86 (2.4) | 38 (1.9) | 34 (1.7) |
| Asthenia | 79 (2.2) | 84 (2.3) | 53 (2.6) | 50 (2.5) |
| Neck pain | 54 (1.5) | 80 (2.2) | 42 (2.1) | 34 (1.7) |
| Insomnia | 68 (1.9) | 72 (2.0) | 36 (1.8) | 34 (1.7) |
| Paresthesia | 62 (1.7) | 72 (2.0) | 34 (1.7) | 29 (1.4) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the label: Major adverse cardiac events [see Boxed Warning and Warnings and Precautions (5.1) ] Hypersensitivity [see Contraindications (4) and Warnings and Precautions (5.2) ] Hypocalcemia [see Contraindications (4) and Warnings and Precautions (5.3) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Subtrochanteric and Diaphyseal Femoral Fractures [see Warnings and Precautions (5.5) ] The most common adverse reactions (≥ 5%) reported with EVENITY in clinical trials were arthralgia and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of EVENITY for the treatment of postmenopausal osteoporosis was evaluated in a multicenter, randomized, double-blind, placebo-controlled study (Study 1, NCT01575834) of 7180 postmenopausal women aged 55 to 90 years (mean age of 71 years). …
Source: FDA drug label, Amgen, Inc, effective July 16, 2026 (SPL set 471baba2-7154-4488-9891-0db2f46791e7), via openFDA; the full label on DailyMed
What do FAERS reports show?
13,496 reports list romosozumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 724 are coded as a death and 3,264 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Romosozumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions