Ninlaro: adverse event reports filed with FDA

10,999

reports as suspect product

0.1% of all reports · about 964 a year

161

reports, 12 months to June 2026

231 in the 12 months before

61.2%

marked serious by the reporter

86% across the class

15.7%

record death among outcomes, as reported

1,729 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Ninlaro reports recording the termmedian drug in proteasome inhibitor

1. Diarrhoealoose or frequent stools12.3%1,356
2. Deaththe patient died; cause not stated by this term10.8%1,192
3. Off label useused for a purpose or in a way not on the label10.7%1,177
4. Plasma cell myeloma10.4%1,142
5. Nauseafeeling sick7.8%856
6. Fatiguetiredness6.7%732
7. Neuropathy peripheralnerve damage in hands or feet5.2%576
8. Pneumonialung infection4.6%502
9. Vomitingbeing sick4.5%494
10. No adverse eventno adverse event was reported4.3%476
11. Rashskin rash4.3%471
12. Platelet count decreasedlow platelet count3.5%389
13. Drug ineffectivethe medicine did not work as expected3.2%357
14. Adverse eventan unwanted medical event, type not specified3.2%356
15. Constipationconstipation3%335
16. Product dose omission issuea dose was missed2.7%297
17. Astheniaweakness or lack of energy2.6%291
18. Malaisegeneral feeling of being unwell2.5%275
19. Peripheral swellingswelling of the arms or legs2.5%275
20. Thrombocytopenialow platelets2.2%244
21. Decreased appetitereduced appetite2.1%231
22. Falla fall2%221
23. Product physical issuea physical defect in the product1.9%211
24. Pyrexiafever1.9%207
25. Dizzinesslight-headedness or unsteadiness1.8%194
26. Back painback pain1.7%187
27. Accidental exposure to product1.7%186
28. White blood cell count decreasedlow white cell count1.6%178
29. Neutropenialow neutrophils, a type of white blood cell1.6%177
30. Hypoaesthesianumbness1.6%173

Top 30 of 784 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 6 drugs in the proteasome inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 109,894 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 69.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 10,999 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ninlaro is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the proteasome inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Ninlaro as a suspect or interacting product; reports listing it only as a concomitant medication (5,846) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.