FDA API: Get drug label
Finds the latest FDA drug label for a brand or generic medicine and returns its uses, directions, warnings, ingredients and a DailyMed link.
Unofficial. Not affiliated with or endorsed by FDA.
Inputs
Values from the run on Oct 23, 2026, shown under Output.
- Medicine, required
medicine The brand or generic medicine name, for example Tylenol or sertraline.
sertraline
Input as JSON
{ "medicine": "sertraline"}Output
{ "type": "Prescription", "used_for": "1 INDICATIONS AND USAGE Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14) ] : Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenst…", "warnings": "5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue sertraline hydrochloride and serotonergic agents and initiate supportive treatment. ( 5.2 ) Increased Risk of Bleeding: Concomitant …", "brand_name": "Sertraline Hydrochloride", "how_to_take": "2 DOSAGE AND ADMINISTRATION Indication Starting Dosage Maximum Dosage MDD ( 2.1 ) 50 mg per day 200 mg per day OCD ( 2.1 ) 25 mg per day (ages 6-12) 50 mg per day (ages ≥ 13) 200 mg per day PD, PTSD, SAD ( 2.1 ) 25 mg per day 200 mg per day PMDD ( 2.2 ) continuous dosing 50 mg per day 150 mg per da…", "generic_name": "SERTRALINE HYDROCHLORIDE", "manufacturer": "REMEDYREPACK INC.", "boxed_warning": "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors …", "dailymed_link": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d598f1a-6c76-458a-a155-7a6a0743a2d3" , "active_ingredients": "SERTRALINE HYDROCHLORIDE\n3 DOSAGE FORMS AND STRENGTHS Sertraline Hydrochloride Tablets USP, 25 mg Tablets: Light Green film coated Modified oval biconvex tablets debossed with I on the left Side of bisect and G on the right Side of bisect on one Side and “212” on other Tablets: 25 mg ( 3 )", "common_side_effects": "6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline [See Contraindications (4) ] QTc prolongation and ventricular arrhythmias when taken with pimozide [See Contraindications (4) , …", "label_effective_date": "2026-09-03", "pregnancy_information": "8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961…"}Code
curl https://api.fous.com/v1/runs \ -H "Authorization: Bearer $FOUS_API_KEY" \ -H "Content-Type: application/json" \ -d '{"method":"open.fda.gov/get_drug_label","input":{"medicine":"sertraline"}}' # Save as fous.py, then run: python3 fous.pyimport json, os, timefrom urllib.error import HTTPErrorfrom urllib.request import Request, urlopenAPI = "https://api.fous.com/v1/runs" KEY = os.environ["FOUS_API_KEY"]HEADERS = { "Authorization": f"Bearer {KEY}", "Content-Type": "application/json" ,}def call(url, body=None): data = json.dumps(body).encode() if body else None request = Request(url, data, HEADERS) try: with urlopen(request, timeout=120) as r: return r.status, json.load(r) except HTTPError as error: message = json.load(error)["error"]["message"] raise RuntimeError(message) from errorstatus, run = call(API, { "method": "open.fda.gov/get_drug_label" , "input": { "medicine": "sertraline" }})# 202: still going after 30 s. Ask again until it ends.while status == 202: time.sleep(2) status, run = call(f"{API}/{run['id']}")print(json.dumps(run["data"], indent=2))// Save as fous.mjs, then run: node fous.mjsconst api = "https://api.fous.com/v1/runs" ;const headers = { Authorization: `Bearer ${process.env.FOUS_API_KEY}`, "Content-Type": "application/json" ,};let response = await fetch(api, { method: "POST", headers, body: JSON.stringify({ "method": "open.fda.gov/get_drug_label" , "input": { "medicine": "sertraline" } }), signal: AbortSignal.timeout(120_000),});let run = await response.json();// 202: still going after 30 s. Ask again until it ends.while (response.status === 202) { await new Promise((done) => setTimeout(done, 2_000)); response = await fetch(`${api}/${run.id}`, { headers }); run = await response.json();}if (!response.ok) throw new Error(run.error.message);console.log(run.data);# Connect your agent to Fous once, over MCP (Streamable HTTP):# https://api.fous.com/mcp# Set FOUS_API_KEY first: create a key at https://app.fous.com/keys.# Claude Codeclaude mcp add \ --scope user \ --transport http fous https://api.fous.com/mcp \ --header "Authorization: Bearer ${FOUS_API_KEY:?Set FOUS_API_KEY to your Fous API key}"# Codexcodex mcp add fous \ --url https://api.fous.com/mcp \ --bearer-token-env-var FOUS_API_KEY# Cursor, VS Code, Windsurf, Cline and morenpx -y add-mcp https://api.fous.com/mcp -g -n fous \ --header "Authorization: Bearer ${FOUS_API_KEY:?Set FOUS_API_KEY to your Fous API key}"# Then ask your agent:# "Use Fous to run open.fda.gov/get_drug_label# with {"medicine":"sertraline"}"Over HTTP, the answer’s data holds the output. A run still going after 30 seconds answers 202 with its id: ask GET /v1/runs/{id} until it ends.
Schema
Input schema
{ "type": "object", "required": [ "medicine" ], "properties": { "medicine": { "type": "string", "minLength": 1, "description": "The brand or generic medicine name, for example Tylenol or sertraline." } }}Output schema
{ "type": "object", "required": [ "brand_name", "generic_name", "manufacturer", "type", "used_for", "active_ingredients", "how_to_take", "boxed_warning", "warnings", "common_side_effects", "pregnancy_information", "label_effective_date", "dailymed_link" ], "properties": { "type": { "type": [ "string", "null" ], "description": "Prescription or over the counter." }, "used_for": { "type": [ "string", "null" ], "description": "Uses and indications from the label." }, "warnings": { "type": [ "string", "null" ], "description": "Warnings or warnings and precautions from the label." }, "brand_name": { "type": [ "string", "null" ], "description": "Brand name on the selected label." }, "how_to_take": { "type": [ "string", "null" ], "description": "Directions or dosage and administration from the label." }, "generic_name": { "type": [ "string", "null" ], "description": "Generic name on the label." }, "manufacturer": { "type": [ "string", "null" ], "description": "Manufacturer or labeler listed by the FDA." }, "boxed_warning": { "type": [ "string", "null" ], "description": "Boxed warning, if any." }, "dailymed_link": { "type": [ "string", "null" ], "description": "Link to the label on DailyMed." }, "active_ingredients": { "type": [ "string", "null" ], "description": "Active ingredients and strengths from the label, when available." }, "common_side_effects": { "type": [ "string", "null" ], "description": "Adverse reactions or side effects listed on the label." }, "label_effective_date": { "type": [ "string", "null" ], "description": "Date this label became effective, in YYYY-MM-DD format." }, "pregnancy_information": { "type": [ "string", "null" ], "description": "Pregnancy information in the label." } }}- Price
- 1 credit per completed run (1¢ with pay as you go); failed runs are free.
- Method
open.fda.gov/get_drug_label- Returns
- brand and generic name, manufacturer, type, uses, directions, boxed warning, warnings, side effects, pregnancy information, effective date, DailyMed link
Use it from your agent
Give your agent this line. It reads SKILL.md, gets a Fous API key and connects the Fous MCP server. Its run then takes the method open.fda.gov/get_drug_label with the inputs above.
Ask your agent
- What are the uses, warnings and side effects listed on the latest label for sertraline?
- Show me the boxed warning and pregnancy information for Lipitor on fda.gov.
- I need the dosing directions and ingredients for Tylenol from its current drug label.
- Find the effective date and DailyMed link for the metformin label.
- Can you pull up the warnings and manufacturer details for amoxicillin?
See more
All FDA methodsFinds FDA drug enforcement recalls by medicine or company name, newest first, with status, class, reason and quantity. Recent recalls may not yet appear.
open.fda.gov/search_drug_recallsLists the most frequently reported reaction terms for a brand or generic medicine in FDA adverse-event reports, with counts and the share of all matching reports. Reports do not establish causation.
open.fda.gov/get_reported_side_effectsFinds FDA food recall enforcement reports by product, brand, or allergen, newest first. Reports are updated weekly and recall statuses may lag.
open.fda.gov/search_food_recallsFinds FDA medical device recalls whose product description or recalling company matches a phrase, newest first, with the recall class and its health-risk meaning from each FDA recall page. An optional start date limits recalls to those initiated on or after it.
fda.gov/search_device_recallsLooks up a medicine by brand or generic name on Drugs.com and returns a plain-language overview: class, uses, availability, schedule, dosage forms, side effects, and pregnancy and breastfeeding notes.
drugs.com/get_drugGets the US cash prices Drugs.com lists for a brand or generic medicine by strength, dosage form and quantity, optionally filtered. Where a range is listed the lower price is returned.
drugs.com/get_drug_pricesFinds possible pill matches on the Drugs.com pill identifier by imprint, optionally narrowed by color and shape, with each pill's labeler.
drugs.com/identify_pillLooks up a medicine in the NHS medicines A to Z and returns its guidance: uses, key facts, who can take it, how to take it, side effects, pregnancy and interactions. Sections absent from NHS guidance are null; a plain name with separate adult and child pages selects the adult page.
nhs.uk/get_medicine