Pharmacologic class (EPC) · 2 drug pages

Allylamine antifungal: adverse event reports filed with FDA

5,123 reports list a drug in this class as a suspect or interacting product, 2004–2026.

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.

5,123
reports across the class: 0% of all reports; 361
reports, 12 months to June 2026: 502 in the 12 months before; 84.9%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Allylamine antifungal is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 5,123 adverse event reports received by FDA, 0% of the database, from April 2004 to June 2026.

361 reports arrived in the 12 months to June 2026, down 28% from 502 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 84.9% of the class's reports are marked serious, 5.8% record death among the outcomes and 25.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (11.6%), rash (6.7%) and ageusia (6.3%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Terbinafine	generic	4,472	315	87.4%	Drug ineffective
Terbinafine hydrochloride	generic	651	46	68%	Drug ineffective

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."

Reports by month, five years

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

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected11.6%593
Rashskin rash6.7%341
Ageusialoss of taste6.3%322
Pruritusitching5.3%271
Drug resistance4.2%215
Dysgeusiaaltered taste4.1%211
Nauseafeeling sick3.9%201
Drug interactionan interaction between medicines3.7%192
Pathogen resistance3.5%177
Malaisegeneral feeling of being unwell3.2%164
Treatment failurethe treatment did not work3.2%163
Fatiguetiredness3.1%159
Urticariahives3.1%157
Acute generalised exanthematous pustulosis3%153
Erythemaskin redness2.8%144
Condition aggravatedthe condition being treated got worse2.8%142
Decreased appetitereduced appetite2.7%138
Product use in unapproved indicationused for a purpose not on the label2.5%128
Headachehead pain2.5%126
Off label useused for a purpose or in a way not on the label2.4%124
Weight decreasedweight loss2.4%123
Arthralgiajoint pain2.4%121
Skin exfoliationpeeling skin2.3%120
Depressionlow mood2.2%114
Pyrexiafever2.1%108

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death5.8%297

Life-threatening4.8%246

Hospitalisation (initial or prolonged)25.7%1,318

Disability6.8%348

Congenital anomaly0.2%10

Other serious64.4%3,298

Not serious15.1%772

Patient age

Under 20.1%5

2 to 111.6%83

12 to 170.8%41

18 to 4423.2%1,189

45 to 6427.3%1,399

65 to 7413.6%699

75 and over8.2%420

Age not given25.1%1,287

Who reported

Physician27.2%1,392

Pharmacist6%309

Other health professional35.3%1,807

Lawyer0%1

Consumer or non-health professional27.2%1,393

Not given4.3%221

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Allylamine antifungal reports

Which drugs are in the Allylamine antifungal class on this site?

Terbinafine and Terbinafine hydrochloride. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

5,123 reports through June 2026, 361 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (11.6%), rash (6.7%), ageusia (6.3%), pruritus (5.3%) and drug resistance (4.2%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.