What the label lists and what reports show
Gadopiclenol side effects
Gadopiclenol's FDA label: “Most common adverse reactions (incidence >0.2%) are injection site pain, headache, nausea, injection site warmth and coldness, dizziness, localized swelling, and erythema.” FAERS holds 243 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 urticaria (56 reports).
- No generic listed
- Boxed warning
Check it at the source: the gadopiclenol FDA label on DailyMed (effective February 22, 2026, Guerbet LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of ELUCIREM?See “What is the most important information I should know about ELUCIREM?” Allergic reactions. ELUCIREM can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction. The most common side effects of ELUCIREM include: injection site pain, headache, nausea, injection site coldness, injection site warmth, dizziness, and localized swelling. These are not all the possible side effects of ELUCIREM. 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, Guerbet LLC, effective February 22, 2026 (SPL set ca582f31-1042-487f-82e4-533f1b541902), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence >0.2%) are injection site pain, headache, nausea, injection site warmth and coldness, dizziness, localized swelling, and erythema.
Table 1. Adverse Reactions Reported in > 0.2% of Patients Receiving ELUCIREM in Clinical Trials
| Adverse Reaction | ELUCIREM 0.05 mmol/kg (n=744) (%) |
|---|---|
| Injection site pain | 0.7 |
| Headache | 0.7 |
| Nausea | 0.4 |
| Injection site warmth | 0.4 |
| Injection site coldness | 0.3 |
| Dizziness | 0.3 |
| Localized swelling | 0.3 |
| Erythema | 0.3 |
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 clinically significant adverse reactions are discussed elsewhere in labeling: Nephrogenic Systemic Fibrosis [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence >0.2%) are injection site pain, headache, nausea, injection site warmth and coldness, dizziness, localized swelling, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS contact GUERBET LLC at 1-877-729-6679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because 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 clinical practice. The safety of ELUCIREM was evaluated in 1,083 patients who received ELUCIREM at doses ranging from 0.025 mmol/kg (one half the recommended dose) to 0.3 mmol/kg (six times the recommended dose). A total of 744 patients (including 116 pediatric patients) received the recommended dose of 0.05 mmol/kg. Among patients who received the recommended dose, the average age was 49 years (range from less than one month to 88 years) and 55% were female. …
Source: FDA drug label, Guerbet LLC, effective February 22, 2026 (SPL set ca582f31-1042-487f-82e4-533f1b541902), via openFDA; the full label on DailyMed
What do FAERS reports show?
243 reports list gadopiclenol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 28 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, 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.
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?
- Gadopiclenol: 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