What the label lists and what reports show
Triptorelin side effects
Triptorelin's FDA label: “The most common adverse reactions (≥ 5%) during TRELSTAR 3.75 mg therapy included hot flushes, skeletal pain, impotence, and headache.” FAERS holds 5,869 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 needle issue (227 reports).
- No generic listed
Check it at the source: the triptorelin FDA label on DailyMed (effective June 30, 2026, Verity 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 TRIPTODUR?TRIPTODUR may cause serious side effects. See “What is the most important information I should know about TRIPTODUR?” The most common side effects of TRIPTODUR include injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infection). These are not all the possible side effects of TRIPTODUR. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label (TRIPTODUR), Azurity Pharmaceuticals, Inc., effective September 14, 2025 (SPL set f41380e7-b830-432d-a5f5-a872932f107e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 5%) during TRELSTAR 3.75 mg therapy included hot flushes, skeletal pain, impotence, and headache.
Table 3. TRELSTAR 11.25 mg: Treatment-Related Adverse Reactions Reported by 1% or More of Patients During Treatment
| Reaction | Adverse Reactions * N | TRELSTAR 11.25 mg N = 174 % |
|---|---|---|
| Injection site pain | 7 | 4.0 |
| Hot flush | 127 | 73.0 |
| Leg pain | 9 | 5.2 |
| Pain | 6 | 3.4 |
| Back pain | 5 | 2.9 |
| Fatigue | 4 | 2.3 |
| Chest pain | 3 | 1.7 |
| Asthenia | 2 | 1.1 |
| Peripheral edema | 2 | 1.1 |
| Hypertension | 7 | 4.0 |
| Dependent edema | 4 | 2.3 |
| Headache | 12 | 6.9 |
| Dizziness | 5 | 2.9 |
| Leg cramps | 3 | 1.7 |
| Breast pain | 4 | 2.3 |
| Gynecomastia | 3 | 1.7 |
| Nausea | 5 | 2.9 |
| Constipation | 3 | 1.7 |
| Dyspepsia | 3 | 1.7 |
| Diarrhea | 2 | 1.1 |
| Abdominal pain | 2 | 1.1 |
| Abnormal hepatic function | 2 | 1.1 |
| Edema in legs | 11 | 6.3 |
| Increased alkaline phosphatase | 3 | 1.7 |
| Skeletal pain | 23 | 13.2 |
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 is discussed in more detail in other sections of the labeling: Hypersensitivity Reactions [ see Warnings and Precautions ( 5.1 ) ] Tumor Flare [ see Warnings and Precautions ( 5.2 ) ]. Metabolic Syndrome [ see Warnings and Precautions ( 5.3 ) ] Cardiovascular Diseases [ see Warnings and Precautions ( 5.4 ) ]. Convulsions [ see Warnings and Precautions ( 5.5 ) ]. Severe Cutaneous Adverse Reactions [ see Warnings and Precautions ( 5.6 ) ]. Effect of QT/QTc Interval [ see Warnings and Precautions ( 5.7 ) ]. 3.75 mg: The most common adverse reactions (≥ 5%) during TRELSTAR 3.75 mg therapy included hot flushes, skeletal pain, impotence, and headache. ( 6.1 ) 11.25 mg: The most common adverse reactions (≥ 5%) during TRELSTAR 11.25 mg therapy included hot flushes, skeletal pain, headache, edema in legs, and leg pain. ( 6.1 ) 22.5 mg: The most common adverse reactions (≥ 5%) during TRELSTAR 22.5 mg therapy included hot flushes, erectile dysfunction, and testicular atrophy. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Verity Pharma at 1-844-837-4891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Verity Pharmaceuticals Inc., effective June 30, 2026 (SPL set b1b84d62-a369-a4b7-5c41-dd1f553a18f3), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,869 reports list triptorelin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 722 are coded as a death and 1,423 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 18 reactions below, 10 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?
- Triptorelin: 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