What the label lists and what reports show
Elinzanetant side effects
Elinzanetant's FDA label: “The most frequently reported (≥5%) adverse reactions were headache, fatigue, dizziness and somnolence.” FAERS holds 251 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 somnolence (48 reports).
- No generic listed
Check it at the source: the elinzanetant FDA label on DailyMed (effective June 16, 2026, Bayer HealthCare Pharmaceuticals Inc.); 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 LYNKUET?LYNKUET can cause serious side effects, including: Central nervous system (CNS) effects and daytime impairment. LYNKUET can cause difficulty staying awake (somnolence) and other nervous system effects including fatigue, having a spinning feeling (vertigo), dizziness, and feeling faint (presyncope). If you experience these effects, you should not drive or do hazardous activities until these effects go away. Increased liver blood test values. LYNKUET may cause increased liver enzymes. Your healthcare provider will do a blood test to check your liver before you start and 3 months after taking LYNKUET. […]
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective June 16, 2026 (SPL set f42884ff-7dff-419c-8a0c-affe2ed73818), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequently reported (≥5%) adverse reactions were headache, fatigue, dizziness and somnolence.
Table 2: Common Adverse Reactions Reported in ≥ 2% in LYNKUET and Greater than Placebo, Weeks 1-52 (OASIS 3)
| Adverse Reaction | LYNKUET N=313 n (%) | Placebo N=314 n (%) |
|---|---|---|
| Headache | 30 (9.6) | 22 (7.0) |
| Fatigue Includes asthenia. | 23 (7.3) | 9 (2.9) |
| Dizziness Includes balance disorder, presyncope, vertigo, vertigo CNS origin, vertigo… | 19 (6.1) | 6 (1.9) |
| Somnolence Includes lethargy. | 16 (5.1) | 4 (1.3) |
| Abdominal pain Includes abdominal discomfort, abdominal pain lower/upper. | 14 (4.5) | 8 (2.5) |
| Rash Includes dermatitis, urticaria. | 13 (4.2) | 5 (1.6) |
| Diarrhea | 12 (3.8) | 3 (1.0) |
| Muscle spasms Includes muscle tightness. | 10 (3.2) | 2 (0.6) |
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 clinically significant adverse reactions are described elsewhere in the labeling: Central Nervous System (CNS) Depressant Effect and Daytime Impairment [see Warnings and Precautions (5.1) ] Hepatic Transaminase Elevations [see Warnings and Precautions (5.2) ] Risk of Seizure [ see Warnings and Precautions (5.4) ] The most frequently reported (≥5%) adverse reactions were headache, fatigue, dizziness and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 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 clinical practice. The safety of LYNKUET was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS 1, OASIS 2, OASIS 3 ) in 1420 women. In OASIS 1 and OASIS 2 combined, 793 women received LYNKUET or placebo for 12 weeks. After the first 12 weeks, 341 women randomized to LYNKUET continued to receive LYNKUET for another 14 weeks, with a total treatment duration of up to 26 weeks. …
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective June 16, 2026 (SPL set f42884ff-7dff-419c-8a0c-affe2ed73818), via openFDA; the full label on DailyMed
What do FAERS reports show?
251 reports list elinzanetant among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 12 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, 11 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.
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?
- Elinzanetant: 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