Drug Safety Information for ANDRODERM (Testosterone)
REMS for Aveed (TESTOSTERONE UNDECANOATE) Rx Drug: FDA Link
FDA Risk Evaluation and Mitigation Strategy REMS
Safety-related Labeling Changes for AXIRON (TESTOSTERONE) Rx Drug: FDA Link
Safety-related Labeling Changes for VOGELXO (TESTOSTERONE) Rx Drug: FDA Link
Safety-related Labeling Changes for NATESTO (TESTOSTERONE) Rx Drug: FDA Link
Safety-related Labeling Changes for DELATESTRYL (TESTOSTERONE ENANTHATE) Brand name discontinued; available as generic: FDA Link
Safety-related Labeling Changes for ANDRODERM (TESTOSTERONE) Rx Drug: FDA Link
Safety-related Labeling Changes for ANDROGEL (TESTOSTERONE) Rx Drug: FDA Link
Safety-related Labeling Changes for TESTIM (TESTOSTERONE) Rx Drug: FDA Link
Safety-related Labeling Changes for FORTESTA (TESTOSTERONE) Rx Drug: FDA Link
Safety-related Labeling Changes for FORTESTA (TESTOSTERONE) Rx Drug: FDA Link
Safety-related Labeling Changes for STRIANT (TESTOSTERONE) Rx Drug: FDA Link
Safety-related Labeling Changes for AVEED (TESTOSTERONE UNDECANOATE) Rx Drug: FDA Link
Safety-related Labeling Changes for AVEED (TESTOSTERONE UNDECANOATE) Rx Drug: FDA Link
Adverse Drug Reactions for ANDRODERM* (Testosterone)
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 ANDRODERM
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Drug ineffective | 1618 |
2 | Blood testosterone decreased | 1515 |
3 | Pain* | 1305 |
4 | Myocardial infarction | 1045 |
5 | Fatigue | 912 |
6 | Economic problem | 902 |
7 | Anxiety* | 847 |
8 | Injury | 811 |
9 | Asthenia | 788 |
10 | Cerebrovascular accident | 618 |
11 | Emotional distress | 603 |
12 | Pulmonary embolism | 558 |
13 | Deep vein thrombosis | 529 |
14 | Headache | 493 |
15 | Dyspnoea | 483 |
16 | Nausea | 444 |
17 | Impaired work ability | 432 |
18 | Drug administered at inappropriate site | 431 |
19 | Dizziness | 406 |
20 | Anhedonia | 388 |
* This side effect also appears in "Top 10 Side Effects of ANDRODERM " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking ANDRODERM
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Blood testosterone decreased | 22969 |
2 | Product used for unknown indication | 9565 |
3 | Hypogonadism* | 2090 |
4 | Androgen replacement therapy | 791 |
5 | Hormone replacement therapy | 714 |
6 | Androgen deficiency | 477 |
7 | Accidental exposure | 448 |
8 | Fatigue | 441 |
9 | Libido decreased | 311 |
10 | Hypogonadism male | 267 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for ANDRODERM
Total Reports Filed with FDA: 63324
Number of FDA Adverse Event Reports by Patient Age for ANDRODERM
Total Reports Filed with FDA: 63324*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Testosterone (Vogelxo, Testoderm tts, Testopel, Sustanon, Pantestone, Natesto, Andriol, Testosterone gel, Androtop, Fortesta, Testoderm, Restandol, Androgel, Testosterone, Androderm, Striant, Axiron, Testim)
Charts are based on 63324 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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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.