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Drug Safety Bundle (Label, Boxed Warning, Top Reported Reactions, Recent Recalls) — 1 Call

Everything public about a drug’s safety in ONE call from openFDA: label indications and warnings, top reported adverse reactions and recent recalls mentioning it.

Call it (no API key)

GET https://api.agentdatahub.de/api/v1/call/bundle-drug-safety?drug=ibuprofen&compact=1

Full metadata: without compact=1 · Markdown: format=llm · Only some fields: add &fields=a,b.c · MCP: tool call_api with {"apiId":"bundle-drug-safety"}

Parameters

Example response (live, compact)

{
  "apiId": "bundle-drug-safety",
  "data_freshness": "cached",
  "data": {
    "drug": "ibuprofen",
    "label": {
      "brand_names": [
        "Ibuprofen Dye Free"
      ],
      "generic_names": [
        "IBUPROFEN"
      ],
      "manufacturer": "CVS Pharmacy",
      "indications": "Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever",
      "boxed_warning": null,
      "warnings": "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: rash facial swelling asthma (wheezing) hives skin reddening shock blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: take more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug have had stomach ulcers or bleeding problems have 3 or more alcoholic drinks every day while using this product are age 60 or older take other drugs containing prescription or nonprescrip",
      "effective_time": "20260429"
    },
    "top_reported_reactions": [
      {
        "reaction": "DRUG INEFFECTIVE",
        "reports": 17135
      },
      {
        "reaction": "PAIN",
        "reports": 16114
      },
      {
        "reaction": "FATIGUE",
        "reports": 15312
      },
      {
        "reaction": "NAUSEA",
        "reports": 14498
      },
      {
        "reaction": "HEADACHE",
        "reports": 12948
      },
      {
        "reaction": "ARTHRALGIA",
        "reports": 11376
      },
      {
        "reaction": "DYSPNOEA",
        "reports": 11213
      },
      {
        "reaction": "VOMITING",
        "reports": 10718
      },
      {
        "reaction": "DIARRHOEA",
        "reports": 10351
      },
      {
        "reaction": "RASH",
        "reports": 9494
      }
    ],
    "recent_recalls": [
      {
        "report_date": "20260325",
        "classification": "Class II",
        "status": "Ongoing",
        "firm": "STRIDES PHARMA INC",
        "product": "Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.",
        "reason": "Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.",
        "country": "United States"
      },
      {
        "report_date": "20260121",
        "classification": "Class II",
        "status": "Ongoing",
        "firm": "GOLD STAR DISTRIBUTION INC",
        "product": "Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 3",
        "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.",
        "country": "United States"
      },
      {
        "report_date": "20250416",
        "classification": "Class II",
        "status": "Ongoing",
        "firm": "Glenmark Pharmaceuticals Inc., USA",
        "product": "Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 0",
        "reason": "CGMP Deviations",
        "country": "United States"
      },
      {
        "report_date": "20241127",
        "classification": "Class III",
        "status": "Ongoing",
        "firm": "Dr. Reddy's Laboratories, Inc.",
        "product": "IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only,  Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05",
        "reason": "Failed Tablet
… (truncated)

Recorded history available: /api/v1/history/bundle-drug-safety?drug=ibuprofen

Source & license