Drug Safety Information for NOVOLIN 70/30 (Insulin recombinant human; insulin susp isophane recombinant human)

Safety-related Labeling Changes for HUMULIN 70/30 (INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for NOVOLIN 70/30 (INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN) Over-the-counter Drug: FDA Link

Adverse Drug Reactions for NOVOLIN 70/30* (Insulin recombinant human; insulin susp isophane 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 NOVOLIN 70/30
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Blood glucose increased1135
2Blood glucose decreased458
3Nausea370
4Product quality issue316
5Weight decreased307
6Drug ineffective278
7Dyspnoea246
8Cerebrovascular accident240
9Asthenia213
10Dizziness213
11Myocardial infarction211
12Cardiac failure congestive198
13Vomiting195
14Visual acuity reduced195
15Decreased appetite192
16Fall182
17Fatigue176
18Hypertension173
19Pain173
20Hypoglycaemia167

* This side effect also appears in "Top 10 Side Effects of NOVOLIN 70/30 " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking NOVOLIN 70/30
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Diabetes mellitus7334
2Type 2 diabetes mellitus2092
3Product used for unknown indication1377
4Type 1 diabetes mellitus737
5Insulin-requiring type 2 diabetes mellitus182
6Hyperglycaemia118
7Blood glucose increased62
8Gestational diabetes50
9Off label use41
10Blood glucose abnormal32

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for NOVOLIN 70/30

Total Reports Filed with FDA: 26760


Number of FDA Adverse Event Reports by Patient Age for NOVOLIN 70/30

Total Reports Filed with FDA: 26760*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Insulin recombinant human; insulin susp isophane recombinant human (Novolin 70/30, Humulin 50/50, Humulin 70/30, Humulin 70/30 pen)

Charts are based on 26760 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 NOVOLIN 70/30 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.