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
1Headache*716
2Death425
3Vomiting359
4Fatigue327
5Convulsion315
6Pyrexia311
7Arthralgia*302
8Malaise254
9Nausea233
10Injection site pain233
11Drug dose omission224
12Pneumonia217
13Condition aggravated210
14Neoplasm recurrence203
15Weight increased194
16Dizziness190
17Pain in extremity188
18Product quality issue179
19Asthenia176
20Diarrhoea172

* 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
1Growth hormone deficiency*8379
2Hypopituitarism4423
3Body height below normal1980
4Product used for unknown indication1639
5Growth retardation961
6Dwarfism941
7Turner's syndrome905
8Prader-willi syndrome598
9Renal failure chronic540
10Small for dates baby438

*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.

Click to go back to search results and GENOTROPIN PRESERVATIVE FREE Reviews and Review Summary .

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.

Visit   DrugInformer.com more on GENOTROPIN PRESERVATIVE FREE's side effects.