What the label lists and what reports show
Pramlintide side effects
Pramlintide's FDA label: “Most common adverse reactions (incidence ≥5% and higher incidence than placebo): nausea, vomiting, anorexia, headache (6.1).” FAERS holds 102 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 blood glucose increased (15 reports).
- No generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the pramlintide FDA label on DailyMed (effective December 18, 2019, AstraZeneca Pharmaceuticals LP); 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 SYMLIN?SYMLIN may cause serious side effects, including: • See “What is the most important information I should know about SYMLIN?” • injection site reactions. SYMLIN may cause bruising, swelling, or itching at the injection site. The most common side effects of SYMLIN include: • nausea • vomiting • decreased appetite • stomach pain • headache Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SYMLIN. For more information, ask your healthcare provider or pharmacist. 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, AstraZeneca Pharmaceuticals LP, effective December 18, 2019 (SPL set 4aea30ff-eb0d-45c1-b114-3127966328ff), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥5% and higher incidence than placebo): nausea, vomiting, anorexia, headache (6.1).
Table 2: Patients with Type 2 Diabetes on Insulin: Common Adverse Reactions (Incidence ≥5% and Greater Incidence with SYMLIN Compared to Placebo) in 2 Pooled Placebo-Controlled Trials
| Reaction | SYMLIN 120 mcg 2 Times Daily + Insulin (N=292) % | Placebo + Insulin (N=284) % |
|---|---|---|
| Nausea | 28 | 12 |
| Headache | 13 | 7 |
| Anorexia | 9 | 2 |
| Vomiting | 8 | 4 |
| Abdominal pain | 8 | 7 |
| Fatigue | 7 | 4 |
| Dizziness | 6 | 4 |
| Cough | 6 | 4 |
| Pharyngitis | 5 | 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, continuedBecause 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 practice. • Most common adverse reactions (incidence ≥5% and higher incidence than placebo): nausea, vomiting, anorexia, headache (6.1). To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Adverse Reactions (Excluding Hypoglycemia) Adverse reactions (excluding hypoglycemia, which is discussed separately below) commonly associated with SYMLIN when coadministered with a fixed dose of insulin in the 26- to 52-week, placebo-controlled trials in patients with type 1 diabetes and patients with type 2 diabetes on mealtime insulin are presented in Table 1 and Table 2, respectively.
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective December 18, 2019 (SPL set 4aea30ff-eb0d-45c1-b114-3127966328ff), via openFDA; the full label on DailyMed
What do FAERS reports show?
102 reports list pramlintide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 25 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 24 reactions below, 5 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?
- Pramlintide: 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