TRIAL RESULTS · SIDE EFFECTS
Pramlintide side effects
ANSWER
In 5 placebo-controlled trials with posted results, the most common side effects of Pramlintide were nausea 28.5% (placebo 4.7%), injection site pruritus 14.7% (placebo 0.7%), injection site erythema 14.5% (placebo 0.9%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
7
with an arm on Pramlintide, of 65 registered
Against placebo
5
placebo-controlled trials
People in those trials
787
on Pramlintide · 253 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Pramlintide beside placebo
Share of people with each side effect in 5 placebo-controlled trials with posted results: 787 people on Pramlintide (all doses), 253 on placebo, same trials. Listed only when reported for at least half of the people on Pramlintide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 162 side effects reported
Every trial with posted results and an arm on Pramlintide (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 | Pramlintide | Placebo | Trials |
|---|---|---|---|---|
| nausea | Gastrointestinal disorders | 28.5% (189 of 663) | 4.7% | 2 |
| injection site pruritus | General disorders | 14.7% (103 of 699) | 0.7% | 3 |
| injection site erythema | General disorders | 14.5% (96 of 663) | 0.9% | 2 |
| Upper respiratory tract infection | Infections and infestations | 12.1% (77 of 638) | 10.4% | 2 |
| injection site bruising | General disorders | 11.2% (74 of 663) | 12.3% | 2 |
| injection site hemorrhage | General disorders | 11.2% (74 of 663) | 3.8% | 2 |
| injection site urticaria | General disorders | 8.3% (55 of 663) | 0.0% | 2 |
| nasopharyngitis | Infections and infestations | 6.6% (44 of 663) | 7.5% | 2 |
| injection site rash | General disorders | 8.9% (41 of 461) | 0.0% | 1 |
| injection site nodule | General disorders | 5.9% (39 of 663) | 3.8% | 2 |
| sinusitis | Respiratory, thoracic and mediastinal disorders | 5.9% (39 of 663) | 2.8% | 2 |
| diarrhea | Gastrointestinal disorders | 5.4% (36 of 663) | 5.7% | 2 |
| headache | Nervous system disorders | 5.1% (34 of 663) | 3.8% | 2 |
| Nausea | Gastrointestinal disorders | 17.5% (31 of 177) | 12.2% | 5 |
| urinary tract infection | Infections and infestations | 4.2% (28 of 663) | 4.7% | 2 |
| injection site induration | General disorders | 3.0% (21 of 699) | 2.1% | 3 |
| vomiting | Gastrointestinal disorders | 3.2% (21 of 663) | 0.0% | 2 |
| gastroenteritis viral | Infections and infestations | 2.9% (19 of 663) | 1.9% | 2 |
| constipation | Gastrointestinal disorders | 2.9% (19 of 663) | 1.9% | 2 |
| dizziness | Nervous system disorders | 2.6% (17 of 663) | 3.8% | 2 |
| injection site inflammation | General disorders | 3.7% (17 of 461) | 0.0% | 1 |
| bronchitis | Infections and infestations | 2.4% (16 of 663) | 0.9% | 2 |
| blood creatine phosphokinase increased | Investigations | 3.5% (16 of 461) | 8.0% | 1 |
| fatigue | General disorders | 3.3% (15 of 461) | 1.3% | 1 |
| pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | 2.1% (14 of 663) | 0.9% | 2 |
| sinus congestion | Respiratory, thoracic and mediastinal disorders | 2.0% (13 of 663) | 3.8% | 2 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 2.6% (12 of 461) | 5.3% | 1 |
| Headache | Nervous system disorders | 12.5% (11 of 88) | 6.3% | 2 |
| Injection Site Bruising | General disorders | 19.6% (11 of 56) | 14.5% | 1 |
| Injection Site Urticaria | General disorders | 16.1% (9 of 56) | 6.0% | 1 |
| Injection Site Erythema | General disorders | 14.3% (8 of 56) | 13.3% | 1 |
| Injection Site Pruritus | General disorders | 14.3% (8 of 56) | 12.0% | 1 |
| influenza | Infections and infestations | 4.0% (8 of 202) | 3.2% | 1 |
| Vomiting | Gastrointestinal disorders | 8.0% (7 of 88) | 2.7% | 2 |
| back pain | Musculoskeletal and connective tissue disorders | 3.5% (7 of 202) | 0.0% | 1 |
| gastroenteritis | Infections and infestations | 3.0% (6 of 202) | 3.2% | 1 |
| muscle strain | Musculoskeletal and connective tissue disorders | 2.5% (5 of 202) | 3.2% | 1 |
| abdominal pain | Gastrointestinal disorders | 2.5% (5 of 202) | 0.0% | 1 |
| abdominal pain upper | Gastrointestinal disorders | 2.5% (5 of 202) | 0.0% | 1 |
| arthralgia | Musculoskeletal and connective tissue disorders | 2.0% (4 of 202) | 0.0% | 1 |
| injection site pain | General disorders | 2.0% (4 of 202) | 0.0% | 1 |
| Hypoglycemia | Endocrine disorders | 18.2% (4 of 22) | - | 1 |
| Nasopharyngitis | Infections and infestations | 3.4% (3 of 88) | 9.0% | 2 |
| Injection Site Nodule | General disorders | 5.4% (3 of 56) | 8.4% | 1 |
| Injection Site Induration | General disorders | 5.4% (3 of 56) | 2.4% | 1 |
| Injection Site Pain | General disorders | 5.4% (3 of 56) | 2.4% | 1 |
| Constipation | Gastrointestinal disorders | 5.4% (3 of 56) | 1.2% | 1 |
| Injection Site Rash | General disorders | 5.4% (3 of 56) | 0.0% | 1 |
| anxiety | Psychiatric disorders | 1.5% (3 of 202) | 0.0% | 1 |
| cough | Respiratory, thoracic and mediastinal disorders | 1.5% (3 of 202) | 0.0% | 1 |
| abdominal distension | Gastrointestinal disorders | 1.5% (3 of 202) | 0.0% | 1 |
| increased appetite | Metabolism and nutrition disorders | 1.5% (3 of 202) | 0.0% | 1 |
| edema peripheral | General disorders | 1.5% (3 of 202) | 0.0% | 1 |
| injection site hematoma | General disorders | 8.3% (3 of 36) | 0.0% | 1 |
| Hypoglycaemia | Metabolism and nutrition disorders | 9.4% (3 of 32) | 0.0% | 1 |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.3% (2 of 663) | 0.0% | 2 |
| Injection Site Haemorrhage | General disorders | 3.6% (2 of 56) | 8.4% | 1 |
| Diarrhoea | Gastrointestinal disorders | 3.6% (2 of 56) | 3.6% | 1 |
| Influenza | Infections and infestations | 3.6% (2 of 56) | 4.8% | 1 |
| ear infection | Infections and infestations | 1.0% (2 of 202) | 6.5% | 1 |
| back injury | Injury, poisoning and procedural complications | 1.0% (2 of 202) | 3.2% | 1 |
| acne | Skin and subcutaneous tissue disorders | 1.0% (2 of 202) | 0.0% | 1 |
| bacteriuria | Infections and infestations | 1.0% (2 of 202) | 0.0% | 1 |
| flushing | Vascular disorders | 1.0% (2 of 202) | 0.0% | 1 |
| hematuria | Renal and urinary disorders | 1.0% (2 of 202) | 0.0% | 1 |
| injection site irritation | General disorders | 1.0% (2 of 202) | 0.0% | 1 |
| muscle spasms | Musculoskeletal and connective tissue disorders | 1.0% (2 of 202) | 0.0% | 1 |
| toothache | Gastrointestinal disorders | 1.0% (2 of 202) | 0.0% | 1 |
| alopecia | Skin and subcutaneous tissue disorders | 1.0% (2 of 202) | 0.0% | 1 |
| chest pain | General disorders | 1.0% (2 of 202) | 0.0% | 1 |
| tooth abscess | Infections and infestations | 1.0% (2 of 202) | 0.0% | 1 |
| urine analysis abnormal | Investigations | 1.0% (2 of 202) | 0.0% | 1 |
| Hypersensitivity | Immune system disorders | 1.8% (1 of 56) | 2.4% | 1 |
| Pharyngitis streptococcal | Infections and infestations | 1.8% (1 of 56) | 3.6% | 1 |
| Myocardial Infarction | Cardiac disorders | 1.8% (1 of 56) | 0.0% | 1 |
| Deep Vein Thrombosis | Vascular disorders | 0.2% (1 of 461) | 0.0% | 1 |
| Convulsion | Nervous system disorders | 0.2% (1 of 461) | 0.0% | 1 |
| Syncope vasovagal | Nervous system disorders | 0.2% (1 of 461) | 0.0% | 1 |
| Cardiac arrest | Cardiac disorders | 0.2% (1 of 461) | 0.0% | 1 |
| Parathyroid Tumor benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.2% (1 of 461) | 0.0% | 1 |
| Goiter | Endocrine disorders | 0.2% (1 of 461) | 0.0% | 1 |
| lymphadenopathy | Blood and lymphatic system disorders | 0.2% (1 of 461) | 0.0% | 1 |
| nasal congestion | Respiratory, thoracic and mediastinal disorders | 0.5% (1 of 202) | 6.5% | 1 |
| joint swelling | Musculoskeletal and connective tissue disorders | 0.5% (1 of 202) | 3.2% | 1 |
| pyrexia | General disorders | 0.5% (1 of 202) | 3.2% | 1 |
| enteritis | Infections and infestations | 0.5% (1 of 202) | 0.0% | 1 |
| eosinophil count increased | Investigations | 0.5% (1 of 202) | 0.0% | 1 |
| insomnia | Psychiatric disorders | 0.5% (1 of 202) | 0.0% | 1 |
| nerve compression | Nervous system disorders | 0.5% (1 of 202) | 0.0% | 1 |
| pharyngitis streptococcal | Infections and infestations | 0.5% (1 of 202) | 0.0% | 1 |
| presyncope | Nervous system disorders | 0.5% (1 of 202) | 0.0% | 1 |
| sinus headache | Nervous system disorders | 0.5% (1 of 202) | 0.0% | 1 |
| thermal burn | Injury, poisoning and procedural complications | 0.5% (1 of 202) | 0.0% | 1 |
| Staphylococcal infection | Infections and infestations | 0.5% (1 of 202) | 0.0% | 1 |
| Muscle strain | Injury, poisoning and procedural complications | 0.5% (1 of 202) | 0.0% | 1 |
| Cardiac enzymes increased | Investigations | 0.5% (1 of 202) | 0.0% | 1 |
| Coronary artery disease | Cardiac disorders | 2.8% (1 of 36) | 0.0% | 1 |
| Hyperglycemia | Endocrine disorders | 4.5% (1 of 22) | - | 1 |
| Elevated liver enzymes | Hepatobiliary disorders | 4.5% (1 of 22) | - | 1 |
| Altered taste (during treatment with study drug) | General disorders | 4.5% (1 of 22) | - | 1 |
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
SymlinPen NDA021332 · label of 2019-12-18 Regulator
Most common adverse reactions (incidence ≥5% and higher incidence than placebo): nausea, vomiting, anorexia, headache.
QUESTIONS
Does pramlintide cause nausea?
In 5 placebo-controlled trials with posted results, 28.5% of people on pramlintide reported nausea, against 4.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does pramlintide cause injection site pruritus?
In 5 placebo-controlled trials with posted results, 14.7% of people on pramlintide reported injection site pruritus, against 0.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does pramlintide cause injection site erythema?
In 5 placebo-controlled trials with posted results, 14.5% of people on pramlintide reported injection site erythema, against 0.9% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does pramlintide cause upper respiratory tract infection?
In 5 placebo-controlled trials with posted results, 12.1% of people on pramlintide reported upper respiratory tract infection, against 10.4% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does pramlintide cause injection site bruising?
In 5 placebo-controlled trials with posted results, 11.2% of people on pramlintide reported injection site bruising, against 12.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
65 registered clinical trials of Pramlintide
The 10 most recently updated are listed.
| NCT07679516 | Postprandial Regulation of Bone Perfusion in Healthy Individuals Status: NOT_YET_RECRUITING · Updated 2026-07-09 |
|---|---|
| NCT06422325 | Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide Status: COMPLETED · Updated 2026-06-09 |
| NCT03560960 | Multi-Center Development of a Novel Diagnostic Test for Alzheimer's Disease Status: ACTIVE_NOT_RECRUITING · Updated 2026-05-28 |
| NCT06619015 | Tailoring Obesity Treatment Trial Status: WITHDRAWN · Updated 2026-04-17 |
| NCT07506369 | Pancreatic Polypeptide as a Modulator of Amylin- Induced Satiety in Healthy Humans Status: RECRUITING · Updated 2026-04-01 |
| NCT07340775 | Hypersensitivity to Amylin in Post-Traumatic Headache Status: NOT_YET_RECRUITING · Updated 2026-01-14 |
| NCT07340788 | Amylin-Induced Migraine Attacks Without Aura Status: NOT_YET_RECRUITING · Updated 2026-01-14 |
| 2024-510802-10-00 | The impact of pramlintide on top of semaglutide in obese people with prediabetes Status: UNKNOWN · Updated 2024-12-03 |
| NCT06046417 | A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes Status: UNKNOWN · Updated 2024-04-18 |
| NCT04074317 | Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D Status: COMPLETED · Updated 2024-03-27 |
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.