MedDRA preferred term · admission to hospital

Hospitalisation: adverse event reports recording this term

150,351 reports to FDA record it, 2004–2026; 0.7% 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.

150,351
reports recording the term: 0.7% of all reports; 12,356
reports, 12 months to June 2026: 13,175 in the 12 months before; 97.4%
marked serious by the reporter: 57.4% across all reports; 6.3%
record death among outcomes, as reported: 9.1% across all reports

"Hospitalisation" (in plain words, admission to hospital) is a MedDRA preferred term recorded in 150,351 adverse event reports received by FDA, 0.7% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

12,356 reports recorded it in the 12 months to June 2026, close to the 13,175 of 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, 97.4% are marked serious, 6.3% include death among the outcomes and 96.7% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Clozapine, Sensipar and Aranesp. 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
Clozapine	Atypical antipsychotic	7,760	10.6%
Sensipar	Calcium-sensing receptor agonist	6,786	16.6%
Aranesp	Erythropoiesis-stimulating agent	5,515	14.8%
Clozaril	Atypical antipsychotic	4,731	9.9%
Humira	—	3,423	0.5%
Opsumit	Endothelin receptor antagonist	3,290	8%
Eliquis	Factor Xa inhibitor	3,193	2.6%
Dupixent	Interleukin-4 receptor alpha antagonist	2,858	0.6%
Epidiolex	—	2,353	13.2%
Adempas	Soluble guanylate cyclase stimulator	1,892	10.2%
Enbrel	Tumor necrosis factor blocker	1,892	0.3%
Xifaxan	Rifamycin antibacterial	1,772	12.7%
Revlimid	Thalidomide analog	1,633	0.5%
Forteo	Parathyroid hormone analog	1,623	1.6%
Imbruvica	Kinase inhibitor	1,560	2.3%
Orencia	Selective T cell costimulation modulator	1,547	1.4%
Prolia	RANK ligand inhibitor	1,517	1.1%
Arikayce	Aminoglycoside antibacterial	1,371	21.2%
Soliris	Complement inhibitor	1,356	2.6%
Kalydeco	Cystic fibrosis transmembrane conductance regulator potentiator	1,328	18.8%
Vedolizumab	Integrin receptor antagonist	1,238	2.1%
Venclexta	BCL-2 inhibitor	1,231	3.5%
Remicade	Tumor necrosis factor blocker	1,216	0.8%
OxyContin	Opioid agonist	1,205	0.8%
Invega Sustenna	Atypical antipsychotic	1,202	5.1%

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 0.7% 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
Atypical antipsychotic	18,450	2.7%	0.5%
Calcium-sensing receptor agonist	6,923	14.7%	1.2%
Kinase inhibitor	6,703	0.8%	0.3%
Erythropoiesis-stimulating agent	6,613	10%	3.5%
Opioid agonist	5,666	0.6%	0.2%
Tumor necrosis factor blocker	5,569	0.5%	0.7%
Endothelin receptor antagonist	5,367	2.8%	2.4%
Factor Xa inhibitor	4,985	1.5%	0.9%
Corticosteroid	4,394	0.5%	0.2%
Thalidomide analog	3,797	0.7%	0.9%

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 20.3%481

2 to 110.9%1,326

12 to 171%1,464

18 to 449%13,491

45 to 6415.1%22,664

65 to 7410.3%15,514

75 and over11.3%16,996

Age not given52.2%78,415

Patient sex

Female48%72,110

Male39.7%59,656

Not given12.4%18,585

Grey bar: all 20,646,523 reports in the database. 71.5% of these reports give the United States as the country.

Questions about "Hospitalisation"

What does "Hospitalisation" mean in an adverse event report?

In plain language: admission to hospital. 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 hospitalisation?

150,351 reports through June 2026 (0.7% of all reports), 12,356 of them in the latest 12 months.

Which drugs appear most often in these reports?

Clozapine (7,760), Sensipar (6,786), Aranesp (5,515), Clozaril (4,731) and Humira (3,423). 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.