MedDRA preferred term · loss of smell

Anosmia: adverse event reports recording this term

14,283 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.

14,283
reports recording the term: 0.1% of all reports; 692
reports, 12 months to June 2026: 743 in the 12 months before; 42.6%
marked serious by the reporter: 57.4% across all reports; 0.5%
record death among outcomes, as reported: 9.1% across all reports

14,283 reports in FDA's adverse event database record the MedDRA term "Anosmia" (in plain words, loss of smell): 0.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

692 reports recorded it in the 12 months to June 2026, close to the 743 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, 42.6% are marked serious, 0.5% include death among the outcomes and 8.2% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Dupixent, Zicam Cold Remedy and All Zicam Products. 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
Dupixent	Interleukin-4 receptor alpha antagonist	1,202	0.3%
Zicam Cold Remedy	—	911	80.1%
All Zicam Products	—	758	99.2%
Zicam	Non-Standardized food allergenic extract	543	64.3%
Zicam Cold Remedy Gel Swabs	—	501	97.7%
Lansoprazole	Proton pump inhibitor	396	1.5%
Digoxin	Cardiac glycoside	389	2.5%
Hydrochlorothiazide	Thiazide diuretic	389	1.7%
Dapagliflozin	Sodium-Glucose cotransporter 2 inhibitor	387	1.8%
Apixaban	Factor Xa inhibitor	386	0.8%
Felodipine	Dihydropyridine calcium channel blocker	383	18.7%
Naproxen	Nonsteroidal anti-inflammatory drug	382	1.6%
Linagliptin	Dipeptidyl peptidase 4 inhibitor	380	13.7%
Simvastatin	HMG-CoA reductase inhibitor	374	1.1%
Isosorbide mononitrate	Nitrate vasodilator	372	11.7%
Isosorbide dinitrate	Nitrate vasodilator	363	27.5%
Imdur	—	362	42.5%
Astrazeneca Covid-19 Vaccine	—	340	35.8%
Levothyroxine sodium	l-Thyroxine	335	2.3%
Flonase	Corticosteroid	321	3.4%
Bisoprolol fumarate	beta-Adrenergic blocker	303	3.7%
Esomeprazole	Proton pump inhibitor	297	1.7%
Candesartan	Angiotensin 2 receptor blocker	270	2.6%
Cetirizine hydrochloride	Histamine-1 receptor antagonist	259	1.4%
Zicam Nasal Products	—	229	98.7%

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
Interleukin-4 receptor alpha antagonist	1,251	0.3%	0.4%
Corticosteroid	1,119	0.1%	0%
Proton pump inhibitor	879	0.2%	0%
Nitrate vasodilator	744	6.2%	1.2%
Non-Standardized food allergenic extract	543	23.3%	0%
Angiotensin 2 receptor blocker	506	0.2%	0%
Nonsteroidal anti-inflammatory drug	492	0.1%	0%
HMG-CoA reductase inhibitor	448	0.2%	0%
Factor Xa inhibitor	440	0.1%	0%
Histamine-1 receptor antagonist	431	0.3%	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%6

2 to 110.2%26

12 to 170.4%57

18 to 4415.1%2,159

45 to 6428.4%4,057

65 to 7410.2%1,459

75 and over6.2%882

Age not given39.5%5,637

Patient sex

Female58.6%8,371

Male34.4%4,919

Not given7%993

Grey bar: all 20,646,523 reports in the database. 75% of these reports give the United States as the country.

Questions about "Anosmia"

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

In plain language: loss of smell. 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 anosmia?

14,283 reports through June 2026 (0.1% of all reports), 692 of them in the latest 12 months.

Which drugs appear most often in these reports?

Dupixent (1,202), Zicam Cold Remedy (911), All Zicam Products (758), Zicam (543) and Zicam Cold Remedy Gel Swabs (501). 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.