Drug Safety Information for GENOTROPIN PRESERVATIVE FREE (Somatropin recombinant)
Safety-related Labeling Changes for HUMATROPE (SOMATROPIN RECOMBINANT) Rx Drug: FDA Link
Safety-related Labeling Changes for SAIZEN (SOMATROPIN RECOMBINANT) Rx Drug: FDA Link
Safety-related Labeling Changes for ZOMACTON (SOMATROPIN RECOMBINANT) Discontinued Drug: FDA Link
Safety-related Labeling Changes for NUTROPIN (SOMATROPIN RECOMBINANT) Rx Drug: FDA Link
Safety-related Labeling Changes for GENOTROPIN (SOMATROPIN RECOMBINANT) Rx Drug: FDA Link
Safety-related Labeling Changes for NUTROPIN AQ (SOMATROPIN RECOMBINANT) Discontinued Drug: FDA Link
Safety-related Labeling Changes for SEROSTIM (SOMATROPIN RECOMBINANT) Discontinued Drug: FDA Link
Safety-related Labeling Changes for NORDITROPIN (SOMATROPIN RECOMBINANT) Rx Drug: FDA Link
Safety-related Labeling Changes for OMNITROPE (SOMATROPIN RECOMBINANT) Rx Drug: FDA Link
Adverse Drug Reactions for GENOTROPIN PRESERVATIVE FREE* (Somatropin recombinant)
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 GENOTROPIN PRESERVATIVE FREE
(reported in FDA Medwatch/FAERS Reports)
|Side Effect||# of FDA Reports|
|10||Injection site pain||233|
|11||Drug dose omission||224|
|17||Pain in extremity||188|
|18||Product quality issue||179|
* This side effect also appears in "Top 10 Side Effects of GENOTROPIN PRESERVATIVE FREE " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking GENOTROPIN PRESERVATIVE FREE
(associated with FDA Medwatch/FAERS Reports)
|Reason||# of FDA Reports|
|1||Growth hormone deficiency*||8379|
|3||Body height below normal||1980|
|4||Product used for unknown indication||1639|
|9||Renal failure chronic||540|
|10||Small for dates baby||438|
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for GENOTROPIN PRESERVATIVE FREE
Total Reports Filed with FDA: 30201
Number of FDA Adverse Event Reports by Patient Age for GENOTROPIN PRESERVATIVE FREE
Total Reports Filed with FDA: 30201*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Somatropin recombinant (Valtropin, Nutropin depot, Accretropin, Serostim lq, Zomacton, Nutropin aq nuspin, Norditropin, Humatrope, Serostim, Nutropin aq, Nutropin aq pen, Bio-tropin, Norditropin flexpro, Omnitrope, Tev-tropin, Nutropin, Genotropin, Saizen, Zorbtive)
Charts are based on 30201 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.
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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.