MedDRA preferred term

Sickle cell anaemia with crisis: adverse event reports recording this term

15,588 reports to FDA record it, 2004–2026; 0.1% of the database.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

15,588
reports recording the term: 0.1% of all reports; 201
reports, 12 months to June 2026: 936 in the 12 months before; 71.5%
marked serious by the reporter: 57.4% across all reports; 1.1%
record death among outcomes, as reported: 9.1% across all reports

15,588 reports in FDA's adverse event database record the MedDRA term "Sickle cell anaemia with crisis": 0.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

201 reports recorded it in the 12 months to June 2026, down 79% from 936 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 71.5% are marked serious, 1.1% include death among the outcomes and 61.3% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Oxbryta, Endari and Exjade. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Oxbryta	—	10,945	50.4%
Endari	—	1,465	44.4%
Exjade	Iron chelator	1,226	6.7%
Adakveo	—	268	23.5%
Deferasirox	Iron chelator	178	9.8%
Ferriprox	Iron chelator	161	6.8%
Voxelotor	—	114	35.5%
Ambrisentan	Endothelin receptor antagonist	77	0.1%
Jadenu	Iron chelator	76	2.7%
Hydroxyurea	Antimetabolite	73	1.7%
Remodulin	Prostacycline vasodilator	64	0.1%
Opsumit	Endothelin receptor antagonist	55	0.1%
Letairis	Endothelin receptor antagonist	43	0.1%
Tracleer	Endothelin receptor antagonist	31	0.1%
Prednisone	Corticosteroid	27	0%
Acetazolamide	Carbonic anhydrase inhibitor	26	1%
Orenitram	Prostacycline vasodilator	26	0.2%
Tyvaso	Prostacycline vasodilator	19	0.1%
Adempas	Soluble guanylate cyclase stimulator	18	0.1%
Dianeal	—	17	0.1%
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose	—	16	0%
Methotrexate	Folate analog metabolic inhibitor	16	0%
Deferiprone	Iron chelator	15	3.7%
Dupixent	Interleukin-4 receptor alpha antagonist	15	0%
Dianeal Low Calcium	—	14	0.1%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. 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."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Iron chelator	1,643	6.3%	6.7%
Endothelin receptor antagonist	210	0.1%	0.1%
Prostacycline vasodilator	114	0.1%	0%
Antimetabolite	82	0.9%	0.3%
Opioid agonist	65	0%	0%
Corticosteroid	46	0%	0%
Carbonic anhydrase inhibitor	26	0.1%	0%
Soluble guanylate cyclase stimulator	18	0.1%	0%
Tumor necrosis factor blocker	18	0%	0%
Folate analog metabolic inhibitor	16	0%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20%4

2 to 114.4%693

12 to 179.8%1,534

18 to 4442.7%6,649

45 to 6414.4%2,246

65 to 741.3%203

75 and over0.1%21

Age not given27.2%4,238

Patient sex

Female60.2%9,386

Male38.5%6,006

Not given1.3%196

Grey bar: all 20,646,523 reports in the database. 97% of these reports give the United States as the country.

Questions about "Sickle cell anaemia with crisis"

What does "Sickle cell anaemia with crisis" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record sickle cell anaemia with crisis?

15,588 reports through June 2026 (0.1% of all reports), 201 of them in the latest 12 months.

Which drugs appear most often in these reports?

Oxbryta (10,945), Endari (1,465), Exjade (1,226), Adakveo (268) and Deferasirox (178). Drugs with many reports overall lead almost every term's list. 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."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

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. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.