Drug Safety Information for LEVOTHYROXINE SODIUM (Levothyroxine sodium)

Safety-related Labeling Changes for THYRO-TABS (LEVOTHYROXINE SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for UNITHROID (LEVOTHYROXINE SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for LEVO-T (LEVOTHYROXINE SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for SYNTHROID (LEVOTHYROXINE SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for TIROSINT (LEVOTHYROXINE SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for TIROSINT-SOL (LEVOTHYROXINE SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for LEVOTHYROXINE SODIUM* (Levothyroxine sodium)

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 LEVOTHYROXINE SODIUM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea11637
2Fatigue*10607
3Drug ineffective10165
4Dyspnoea8980
5Headache*8666
6Dizziness8460
7Diarrhoea8417
8Pain7488
9Asthenia7047
10Vomiting6435
11Fall6073
12Arthralgia*5756
13Malaise5589
14Pain in extremity5296
15Weight decreased4947
16Insomnia*4868
17Anxiety*4690
18Pruritus4680
19Rash4678
20Depression*4345

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

Top 10 Reasons for Taking LEVOTHYROXINE SODIUM
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hypothyroidism*143943
2Product used for unknown indication82010
3Thyroid disorder52013
4Thyroidectomy*6195
5Autoimmune thyroiditis*5473
6Hyperthyroidism3932
7Basedow's disease1570
8Thyroid hormone replacement therapy1379
9Hormone replacement therapy1359
10Blood thyroid stimulating hormone decreased1083

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


Types of Adverse Events for LEVOTHYROXINE SODIUM

Total Reports Filed with FDA: 804746


Number of FDA Adverse Event Reports by Patient Age for LEVOTHYROXINE SODIUM

Total Reports Filed with FDA: 804746*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Levothyroxine sodium (L-thyrox, Levotabs, L-thyroxine roche, Levothyroxine, Novothyrox, Dexnon, Euthyrox, T4, Levotiroxina sodica, Eutirox, Thyroxine, Sodium levothyroxine, Thyrax, Oroxine, Berlthyrox, Tirosint, Thyroxine sodium, Thyroxin, L-thyroxin henning, Novothyral, Levoxine, Levothyrox, Eltroxin, Tiroxina, Eltroxine, L thyroxine, L-thyroxine, Thyrox, Levothyroid, Eferox, Levoxyl, Levothyroxine sodium, Unithroid, Synthroid, Levolet, Tiroxina sodica, Levo-t, Levothroid)

Charts are based on 804746 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 LEVOTHYROXINE SODIUM 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.