Drug Safety Information for AFREZZA (Insulin recombinant human)
FDA Safety-related Labeling Changes for HUMULIN R (INSULIN RECOMBINANT HUMAN) Over-the-counter Drug: Safety Information Link
FDA Safety-related Labeling Changes for HUMULIN 70/30 (INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN) Over-the-counter Drug: Safety Information Link
FDA Safety-related Labeling Changes for NOVOLIN R (INSULIN RECOMBINANT HUMAN) Over-the-counter Drug: Safety Information Link
FDA Safety-related Labeling Changes for NOVOLIN 70/30 (INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN) Over-the-counter Drug: Safety Information Link
FDA Safety-related Labeling Changes for AFREZZA (INSULIN RECOMBINANT HUMAN) Rx Drug: Safety Information Link
Required post-approval safety study:
An open-label pharmacokinetic (PK), and multiple-dose safety and tolerability dose-titration trial of Afrezza in pediatric patients ages 4 to 17 years (inclusive) with type 1 diabetes (Part 1), followed by a prospective, multicenter, open-label, randomized, controlled trial comparing the efficacy and safety of prandial Afrezza to prandial subcutaneous insulin aspart used in combination with subcutaneous basal insulin in pediatric patients 4 to 17 years old (inclusive) with type 1 or type 2 diabetes (Part 2). Part 2 of the trial should include a 4-week run-in phase and a 52-week randomized intervention phase. Due Date: 2021-01-31
Original FDA Drug Approval Date for AFREZZA: 2014-06-27
Adverse Drug Reactions for AFREZZA* (Insulin recombinant human)
These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).
Top 20 Adverse Effects Associated with AFREZZA
(reported in FDA Medwatch/FAERS Reports)
| Side Effect | # of FDA Reports | |
|---|---|---|
| 1 | Blood glucose increased | 1425 |
| 2 | Blood glucose decreased | 610 |
| 3 | Product quality issue | 432 |
| 4 | Drug ineffective | 415 |
| 5 | Hypoglycaemia | 389 |
| 6 | Nausea | 334 |
| 7 | Dyspnoea | 326 |
| 8 | Diabetes mellitus inadequate control | 314 |
| 9 | Myocardial infarction | 313 |
| 10 | Vomiting | 261 |
| 11 | Blood glucose fluctuation | 260 |
| 12 | Cerebrovascular accident | 259 |
| 13 | Hypertension | 257 |
| 14 | Fall | 243 |
| 15 | Asthenia | 241 |
| 16 | Loss of consciousness | 240 |
| 17 | Weight decreased | 239 |
| 18 | Renal failure | 239 |
| 19 | Pneumonia | 224 |
| 20 | Malaise | 223 |
* This side effect also appears in "Top 10 Side Effects of AFREZZA " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking AFREZZA
(associated with FDA Medwatch/FAERS Reports)
| Reason | # of FDA Reports | |
|---|---|---|
| 1 | Diabetes mellitus | 12141 |
| 2 | Product used for unknown indication | 2016 |
| 3 | Type 2 diabetes mellitus | 2013 |
| 4 | Type 1 diabetes mellitus | 1887 |
| 5 | Gestational diabetes | 335 |
| 6 | Blood glucose increased | 214 |
| 7 | Insulin-requiring type 2 diabetes mellitus | 197 |
| 8 | Hyperglycaemia | 189 |
| 9 | Blood glucose | 96 |
| 10 | Blood insulin | 69 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for AFREZZA
Total Reports Filed with FDA: 39190
Number of FDA Adverse Event Reports by Patient Age for AFREZZA
Total Reports Filed with FDA: 39190*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Insulin recombinant human (Velosulin br, Humulin br, Humulin r, Humulin r pen, Exubera, Afrezza, Novolin r)
Charts are based on 39190 reports filed with the FDA between 2004 and June 2015.
Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.
Click to go back to search results and AFREZZA Reviews and Review Summary .
Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.