Reported Reactions

Drugs

Product name as reported

Equate Nts 21mg: adverse event reports filed with FDA

307 reports list it as a suspect or interacting product, 2005–2013.

307
reports as suspect product
0% of all reports · about 14 a year
0
reports, 12 months to June 2026
0 in the 12 months before
2%
marked serious by the reporter
57.4% across all reports
0%
record death among outcomes, as reported
0 reports · not verified by FDA

307 adverse event reports received by FDA list the product name "Equate Nts 21mg" as reporters wrote it as a suspect or interacting product, from January 2005 to December 2013. A further 0 reports list it only as a concomitant medication, and those are not counted in the figures on this page.

In the 12 months to June 2026, 0 reports listed it, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 14 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.

The reactions recorded most often are application site pruritus (23.1%), application site erythema (20.2%) and nausea (16.9%). A report can list several reactions, so shares add to more than 100%; 71 different terms appear across these reports. Application site pruritus is recorded in 23.1% of these reports, against 0.1% of all reports in the database.

2% of the reports are marked serious by the reporter; 0% record death among the outcomes and 0% record hospitalisation, as reported. 100% of the reports came from consumers, and the largest patient age group is 18 to 44 (44.3%). 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

No report listing Equate Nts 21mg was received in the five years to June 2026; the latest was received in December 2013.

By year received

0771542005: 14120052006: 15420062007: 220072009: 120092012: 220122013: 72013

Reactions recorded in the reports

share of Equate Nts 21mg reports recording the termall reports in the database

  1. Application site pruritusitching where the product was applied23.1%71
  2. Application site erythemaredness where the product was applied20.2%62
  3. Nauseafeeling sick16.9%52
  4. Application site irritation12.7%39
  5. Dizzinesslight-headedness or unsteadiness10.1%31
  6. Nicotine dependence8.5%26
  7. Headachehead pain6.2%19
  8. Insomniadifficulty sleeping6.2%19
  9. Application site pain5.9%18
  10. Drug ineffectivethe medicine did not work as expected5.5%17
  11. Abnormal dreamsunusual dreams5.2%16
  12. Pain in extremitypain in an arm or leg5.2%16
  13. Application site reactiona reaction where the product was applied4.9%15
  14. Heart rate increaseda fast heart rate reading4.9%15
  15. Application site swelling4.6%14
  16. Vomitingbeing sick4.2%13
  17. Hypersensitivityan allergic-type reaction3.9%12
  18. Application site rash3.3%10
  19. Application site urticaria3.3%10
  20. Hyperhidrosisexcessive sweating3.3%10
  21. Malaisegeneral feeling of being unwell3.3%10
  22. Rashskin rash3.3%10
  23. Hypoaesthesianumbness2.9%9
  24. Application site dermatitis2.6%8
  25. Astheniaweakness or lack of energy2.6%8
  26. Nervousnessnervousness2.6%8
  27. Tremorshaking2.3%7
  28. Application site warmth2%6
  29. Feeling jittery2%6
  30. Intentional drug misuse2%6

Top 30 of 71 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 share of all reports in the database; 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

Death0%0
Life-threatening0%0
Hospitalisation (initial or prolonged)0%0
Disability0%0
Congenital anomaly0%0
Other serious2%6
Not serious98%301

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 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 20%0
2 to 110%0
12 to 170%0
18 to 4444.3%136
45 to 6436.8%113
65 to 748.1%25
75 and over1.3%4
Age not given9.4%29

Patient sex

Female70.7%217
Male23.1%71
Not given6.2%19

Who reported

Physician0%0
Pharmacist0%0
Other health professional0%0
Lawyer0%0
Consumer or non-health professional100%307
Not given0%0

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Smoking cessation therapy4815.6%

The indication field is filled in by the reporter and is often blank; shares are of all 307 reports.

In context

MeasureEquate Nts 21mgAll reports
Reports as suspect product30720,646,523
Share of that pool—0%
Reports, latest 12 months01,332,454
Marked serious2%57.4%
Death recorded among outcomes, per 1,000 reports091
Hospitalisation recorded, per 1,000 reports0213
Consumer-filed share100%45.8%
Top term, share of reportsApplication site pruritus 23.1%0.1%

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."

Questions about Equate Nts 21mg reports

How many adverse event reports has FDA received for Equate Nts 21mg?

307 reports list Equate Nts 21mg as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 0 list it only as a concomitant medication.

What reactions are recorded in Equate Nts 21mg reports?

application site pruritus (23.1%), application site erythema (20.2%), nausea (16.9%), application site irritation (12.7%) and dizziness (10.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Equate Nts 21mg was responsible.

How serious are the reports?

2% are marked serious by the reporter. Among the outcomes recorded, 0% of reports include death and 0% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

consumer or non-health professional (100%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Equate Nts 21mg rising?

0 reports in the 12 months to June 2026, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Equate Nts 21mg was responsible for these reactions?

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." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Equate Nts 21mg?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.

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 Equate Nts 21mg as a suspect or interacting product; reports listing it only as a concomitant medication (0) 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.

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