TRIAL RESULTS · SIDE EFFECTS
Abaloparatide side effects
ANSWER
In 4 placebo-controlled trials with posted results, the most common side effects of Abaloparatide were hypercalciuria 9.7% (placebo 8.9%), dizziness 9.4% (placebo 5.5%), nasopharyngitis 8.8% (placebo 8.5%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
7
with an arm on Abaloparatide, of 25 registered
Against placebo
4
placebo-controlled trials
People in those trials
1,723
on Abaloparatide · 1,529 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Abaloparatide beside placebo
Share of people with each side effect in 4 placebo-controlled trials with posted results: 1,723 people on Abaloparatide (all doses), 1,529 on placebo, same trials. Listed only when reported for at least half of the people on Abaloparatide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 309 side effects reported
Every trial with posted results and an arm on Abaloparatide (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | Abaloparatide | Placebo | Trials |
|---|---|---|---|---|
| Application site erythema | General disorders | 33.0% (240 of 727) | 4.0% | 3 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 8.4% (188 of 2,229) | 9.3% | 5 |
| Application site pain | General disorders | 33.3% (176 of 528) | - | 2 |
| Injection site erythema | General disorders | 19.6% (167 of 854) | 3.1% | 3 |
| Back pain | Musculoskeletal and connective tissue disorders | 7.3% (163 of 2,229) | 8.2% | 5 |
| Dizziness | Nervous system disorders | 9.1% (155 of 1,699) | 5.5% | 5 |
| Headache | Nervous system disorders | 9.0% (153 of 1,699) | 6.1% | 5 |
| Application site swelling | General disorders | 26.3% (139 of 528) | - | 2 |
| Application site oedema | General disorders | 25.9% (137 of 528) | - | 2 |
| Nausea | Gastrointestinal disorders | 8.7% (135 of 1,550) | 3.1% | 4 |
| Upper respiratory tract infection | Infections and infestations | 6.9% (121 of 1,746) | 7.8% | 5 |
| Hypercalciuria | Renal and urinary disorders | 7.7% (118 of 1,527) | 8.9% | 3 |
| Hypertension | Vascular disorders | 5.8% (117 of 2,030) | 6.0% | 4 |
| Injection site pain | General disorders | 16.5% (108 of 655) | 0.0% | 2 |
| Application site pruritus | General disorders | 14.3% (104 of 727) | 0.0% | 3 |
| Nasopharyngitis | Infections and infestations | 8.8% (103 of 1,170) | 8.5% | 3 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 4.8% (91 of 1,881) | 5.7% | 3 |
| Urinary tract infection | Infections and infestations | 6.5% (86 of 1,328) | 4.6% | 2 |
| Application site haemorrhage | General disorders | 15.3% (81 of 528) | - | 2 |
| Palpitations | Cardiac disorders | 4.6% (71 of 1,527) | 0.3% | 3 |
| Influenza | Infections and infestations | 5.8% (68 of 1,170) | 4.5% | 3 |
| Injection site swelling | General disorders | 10.4% (68 of 655) | 0.0% | 2 |
| Injection site pruritus | General disorders | 11.3% (57 of 506) | - | 1 |
| Injection site oedema | General disorders | 8.5% (43 of 506) | - | 1 |
| Orthostatic hypotension | Vascular disorders | 7.7% (39 of 506) | - | 1 |
| Application site discolouration | General disorders | 7.3% (37 of 506) | - | 1 |
| Constipation | Gastrointestinal disorders | 4.4% (36 of 822) | 5.1% | 1 |
| Injection site bruising | General disorders | 7.1% (36 of 506) | - | 1 |
| Injection site haemorrhage | General disorders | 7.1% (36 of 506) | - | 1 |
| COVID-19 | Infections and infestations | 5.3% (27 of 506) | - | 1 |
| Fatigue | General disorders | 4.0% (20 of 506) | - | 1 |
| Application site reaction | General disorders | 3.6% (18 of 506) | - | 1 |
| Administration site erythema | General disorders | 3.4% (17 of 506) | - | 1 |
| Application site vesicles | General disorders | 3.4% (17 of 506) | - | 1 |
| Bronchitis | Infections and infestations | 1.2% (14 of 1,170) | 0.2% | 3 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 0.6% (12 of 2,080) | 0.3% | 4 |
| Diarrhoea | Gastrointestinal disorders | 4.5% (10 of 222) | 0.0% | 2 |
| Hypocalcaemia | Metabolism and nutrition disorders | 4.0% (8 of 199) | 4.0% | 1 |
| Cystitis | Infections and infestations | 3.5% (7 of 199) | 2.0% | 1 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 3.5% (7 of 199) | 2.0% | 1 |
| Transient ischaemic attack | Nervous system disorders | 0.4% (6 of 1,375) | 0.1% | 2 |
| Influenza like illness | General disorders | 3.0% (6 of 199) | 4.0% | 1 |
| Sinusitis | Infections and infestations | 4.0% (6 of 149) | 5.1% | 1 |
| Cholelithiasis | Hepatobiliary disorders | 0.3% (5 of 1,881) | 0.1% | 3 |
| Vertigo | Ear and labyrinth disorders | 0.4% (5 of 1,375) | 0.1% | 2 |
| Atrial fibrillation | Cardiac disorders | 0.2% (4 of 1,904) | 0.1% | 4 |
| Spinal compression fracture | Injury, poisoning and procedural complications | 0.2% (3 of 1,881) | 0.0% | 3 |
| Supraventricular tachycardia | Cardiac disorders | 0.3% (3 of 971) | 0.0% | 2 |
| Humerus fracture | Injury, poisoning and procedural complications | 0.2% (3 of 1,328) | 0.0% | 2 |
| Sciatica | Nervous system disorders | 0.2% (3 of 1,375) | 0.0% | 2 |
| Ovarian cyst | Reproductive system and breast disorders | 0.2% (3 of 1,375) | 0.1% | 2 |
| Fall | Injury, poisoning and procedural complications | 0.6% (3 of 529) | - | 2 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.4% (3 of 822) | 0.1% | 1 |
| Bursitis | Musculoskeletal and connective tissue disorders | 13.0% (3 of 23) | - | 1 |
| Pyrexia | General disorders | 0.1% (2 of 1,881) | 0.1% | 3 |
| Gastroenteritis | Infections and infestations | 0.1% (2 of 1,881) | 0.0% | 3 |
| Meniscus injury | Injury, poisoning and procedural complications | 0.1% (2 of 1,881) | 0.3% | 3 |
| Coronary artery disease | Cardiac disorders | 0.2% (2 of 1,258) | 0.2% | 3 |
| Anaemia | Blood and lymphatic system disorders | 0.1% (2 of 1,375) | 0.0% | 2 |
| Myocardial ischaemia | Cardiac disorders | 0.1% (2 of 1,375) | 0.1% | 2 |
| Angina pectoris | Cardiac disorders | 0.1% (2 of 1,375) | 0.1% | 2 |
| Abdominal pain | Gastrointestinal disorders | 0.1% (2 of 1,375) | 0.3% | 2 |
| Colitis | Gastrointestinal disorders | 0.2% (2 of 1,021) | 0.0% | 2 |
| Vomiting | Gastrointestinal disorders | 0.2% (2 of 845) | 0.0% | 2 |
| Appendicitis | Infections and infestations | 0.2% (2 of 971) | 0.0% | 2 |
| Bronchopneumonia | Infections and infestations | 0.1% (2 of 1,375) | 0.1% | 2 |
| Pneumonia | Infections and infestations | 0.1% (2 of 1,375) | 0.2% | 2 |
| Upper limb fracture | Injury, poisoning and procedural complications | 0.1% (2 of 1,375) | 0.2% | 2 |
| Wrist fracture | Injury, poisoning and procedural complications | 0.1% (2 of 1,375) | 0.1% | 2 |
| Hyperglycaemia | Metabolism and nutrition disorders | 0.2% (2 of 1,328) | 0.0% | 2 |
| Syncope | Nervous system disorders | 0.2% (2 of 1,328) | 0.1% | 2 |
| Ischaemic stroke | Nervous system disorders | 0.1% (2 of 1,375) | 0.3% | 2 |
| Uterine prolapse | Reproductive system and breast disorders | 0.1% (2 of 1,375) | 0.2% | 2 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 0.2% (2 of 1,328) | 0.0% | 2 |
| Head injury | Injury, poisoning and procedural complications | 0.2% (2 of 1,059) | 0.0% | 2 |
| Transient global amnesia | Nervous system disorders | 0.2% (2 of 1,059) | 0.0% | 2 |
| Small intestinal obstruction | Gastrointestinal disorders | 0.3% (2 of 655) | 0.0% | 2 |
| Gastric Ulcer | Gastrointestinal disorders | 0.2% (2 of 822) | 0.0% | 1 |
| Sepsis | Infections and infestations | 0.2% (2 of 822) | 0.0% | 1 |
| Hypoglycaemia | Metabolism and nutrition disorders | 0.2% (2 of 822) | 0.0% | 1 |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.2% (2 of 822) | 0.0% | 1 |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | 0.2% (2 of 822) | 0.0% | 1 |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.4% (2 of 553) | 0.0% | 1 |
| Wheezing | Respiratory, thoracic and mediastinal disorders | 8.7% (2 of 23) | - | 1 |
| Ecchymosis | Skin and subcutaneous tissue disorders | 8.7% (2 of 23) | - | 1 |
| COVID-19 pneumonia | Infections and infestations | 0.4% (2 of 506) | - | 1 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 0.4% (2 of 506) | - | 1 |
| Burning sensation | Nervous system disorders | 9.1% (2 of 22) | - | 1 |
| Acute myocardial infarction | Cardiac disorders | 0.1% (1 of 1,524) | 0.3% | 3 |
| Cerebrovascular accident | Nervous system disorders | 0.1% (1 of 1,524) | 0.2% | 3 |
| Angina unstable | Cardiac disorders | 0.1% (1 of 971) | 0.1% | 2 |
| Haemorrhoids | Gastrointestinal disorders | 0.1% (1 of 1,375) | 0.1% | 2 |
| Gastritis | Gastrointestinal disorders | 0.1% (1 of 1,375) | 0.0% | 2 |
| Large intestine polyp | Gastrointestinal disorders | 0.1% (1 of 1,328) | 0.2% | 2 |
| Chest pain | General disorders | 0.1% (1 of 1,375) | 0.2% | 2 |
| Lower limb fracture | Injury, poisoning and procedural complications | 0.1% (1 of 1,375) | 0.2% | 2 |
| Pelvic fracture | Injury, poisoning and procedural complications | 0.1% (1 of 1,328) | 0.1% | 2 |
| Radius fracture | Injury, poisoning and procedural complications | 0.1% (1 of 1,021) | 0.1% | 2 |
| Tibia fracture | Injury, poisoning and procedural complications | 0.1% (1 of 1,328) | 0.1% | 2 |
| Hypercalcaemia | Metabolism and nutrition disorders | 0.1% (1 of 1,328) | 0.0% | 2 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
FDA LABEL
What the FDA label says
Tymlos NDA208743 · label of 2026-08-11 Regulator
The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo.
QUESTIONS
Does abaloparatide cause hypercalciuria?
In 4 placebo-controlled trials with posted results, 9.7% of people on abaloparatide reported hypercalciuria, against 8.9% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does abaloparatide cause dizziness?
In 4 placebo-controlled trials with posted results, 9.4% of people on abaloparatide reported dizziness, against 5.5% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does abaloparatide cause nasopharyngitis?
In 4 placebo-controlled trials with posted results, 8.8% of people on abaloparatide reported nasopharyngitis, against 8.5% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does abaloparatide cause arthralgia?
In 4 placebo-controlled trials with posted results, 8.3% of people on abaloparatide reported arthralgia, against 9.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does abaloparatide cause nausea?
In 4 placebo-controlled trials with posted results, 8.0% of people on abaloparatide reported nausea, against 3.1% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
25 registered clinical trials of Abaloparatide
The 10 most recently updated are listed.
| NCT03841058 | Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery Status: ACTIVE_NOT_RECRUITING · Updated 2026-09-28 |
|---|---|
| NCT07587775 | The Effect of Osteoporotic Medications on Vertebral Bone Quality Score Status: ENROLLING_BY_INVITATION · Updated 2026-07-23 |
| NCT06164795 | Sequential Therapies After Osteoanabolic Treatment Status: RECRUITING · Updated 2026-07-22 |
| NCT04467983 | Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone Status: ACTIVE_NOT_RECRUITING · Updated 2026-06-08 |
| NCT04167163 | Abaloparatide Before Total Knee Arthroplasty Status: COMPLETED · Updated 2026-06-05 |
| NCT07616401 | MicroRNA and Markers and Therapeutic Response to Romosozumab and Abaloparatide in Postmenopausal Osteoporosis Status: RECRUITING · Updated 2026-06-01 |
| NCT06898060 | To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture Status: NOT_YET_RECRUITING · Updated 2025-03-27 |
| NCT06753864 | A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult Subjects Status: NOT_YET_RECRUITING · Updated 2024-12-31 |
| NCT04760782 | PTH Analog Type II Odontoid Fracture Status: TERMINATED · Updated 2024-09-19 |
| NCT04249232 | Abaloparatide and Pelvic Fracture Healing Status: COMPLETED · Updated 2024-06-14 |
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New trials, approvals and enforcement actions. One email a week.