Drug
Metreleptin
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Blood Triglycerides Increased | 53 | 50.5 | 52.7 | signal |
| 2 | Therapy Cessation | 92 | 30.4 | 32.8 | signal |
| 3 | Glycosylated Haemoglobin Increased | 41 | 27.5 | 28.4 | signal |
| 4 | Hepatic Steatosis | 25 | 22.7 | 23.1 | signal |
| 5 | Diabetes Mellitus Inadequate Control | 21 | 20.0 | 20.3 | signal |
| 6 | Hepatomegaly | 10 | 17.1 | 17.2 | signal |
| 7 | Treatment Noncompliance | 52 | 16.1 | 16.8 | signal |
| 8 | Therapy Interrupted | 66 | 16.1 | 17.0 | signal |
| 9 | Pancreatitis Acute | 21 | 15.9 | 16.1 | signal |
| 10 | Blood Glucose Abnormal | 17 | 15.5 | 15.7 | signal |
| 11 | Hypoglycaemia | 40 | 13.9 | 14.3 | signal |
| 12 | Iron Deficiency Anaemia | 7 | 12.9 | 12.9 | signal |
| 13 | Hunger | 10 | 12.5 | 12.6 | signal |
| 14 | Hyperglycaemia | 27 | 12.5 | 12.8 | signal |
| 15 | Increased Appetite | 13 | 11.7 | 11.8 | signal |
| 16 | Blood Glucose Decreased | 33 | 11.5 | 11.8 | signal |
| 17 | Hepatic Encephalopathy | 6 | 10.8 | 10.9 | signal |
| 18 | Pancreatitis | 33 | 10.5 | 10.8 | signal |
| 19 | Diabetic Ketoacidosis | 14 | 9.9 | 10.0 | signal |
| 20 | Weight Fluctuation | 6 | 9.7 | 9.8 | signal |
| 21 | Needle Issue | 16 | 9.4 | 9.5 | signal |
| 22 | Blood Glucose Fluctuation | 6 | 9.2 | 9.2 | signal |
| 23 | Maternal Exposure During Pregnancy | 48 | 9.2 | 9.5 | signal |
| 24 | Urosepsis | 5 | 9.1 | 9.2 | signal |
| 25 | Diabetes Mellitus | 37 | 8.1 | 8.4 | signal |
| 26 | Ill-defined Disorder | 27 | 7.5 | 7.6 | signal |
| 27 | Osteomyelitis | 8 | 7.5 | 7.5 | signal |
| 28 | Blood Glucose Increased | 82 | 7.3 | 7.8 | signal |
| 29 | Appendicitis | 4 | 7.3 | 7.3 | signal |
| 30 | Insurance Issue | 6 | 6.8 | 6.8 | signal |
| 31 | Injection Site Discolouration | 5 | 6.8 | 6.8 | signal |
| 32 | Injection Site Extravasation | 5 | 6.8 | 6.8 | signal |
| 33 | Product Use Complaint | 6 | 6.5 | 6.6 | signal |
| 34 | Injection Site Induration | 5 | 6.5 | 6.5 | signal |
| 35 | Intentional Dose Omission | 10 | 6.2 | 6.2 | signal |
| 36 | Injection Site Mass | 13 | 5.9 | 6.0 | signal |
| 37 | Product Dose Omission Issue | 98 | 5.8 | 6.2 | signal |
| 38 | Post Procedural Haemorrhage | 4 | 5.8 | 5.8 | signal |
| 39 | Product Dose Omission | 21 | 5.3 | 5.4 | signal |
| 40 | Amenorrhoea | 5 | 5.0 | 5.1 | signal |
| 41 | Ovarian Cyst | 3 | 5.0 | 5.0 | signal |
| 42 | Injection Site Pruritus | 19 | 4.8 | 4.9 | signal |
| 43 | Syringe Issue | 5 | 4.8 | 4.8 | signal |
| 44 | Injection Site Urticaria | 6 | 4.2 | 4.2 | signal |
| 45 | Injection Site Irritation | 3 | 4.0 | 4.0 | signal |
| 46 | Abortion Spontaneous | 9 | 3.8 | 3.8 | signal |
| 47 | Injection Site Haemorrhage | 16 | 3.4 | 3.4 | signal |
| 48 | Pregnancy | 4 | 3.3 | 3.3 | signal |
| 49 | Injection Site Warmth | 4 | 3.3 | 3.3 | signal |
| 50 | Premature Delivery | 3 | 3.2 | 3.2 | no signal |
| 51 | Injection Site Bruising | 14 | 3.0 | 3.0 | signal |
| 52 | Injection Site Reaction | 12 | 2.9 | 3.0 | signal |
| 53 | Injection Site Swelling | 13 | 2.9 | 2.9 | signal |
| 54 | Injection Site Rash | 5 | 2.8 | 2.8 | signal |
| 55 | Product Complaint | 4 | 2.7 | 2.7 | no signal |
| 56 | Injection Site Pain | 48 | 2.7 | 2.7 | signal |
| 57 | Injection Site Erythema | 19 | 2.6 | 2.6 | signal |
| 58 | Menstruation Irregular | 4 | 2.5 | 2.5 | no signal |
| 59 | Product Storage Error | 9 | 1.8 | 1.8 | no signal |
| 60 | Device Difficult To Use | 3 | 0.8 | 0.8 | no signal |