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What the label lists and what reports show

Tetradecyl hydrogen side effects

Tetradecyl hydrogen's FDA label lists its adverse reactions in its own words. FAERS holds 138 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is injection site haematoma (10 reports).

  • Generic listed

Check it at the source: the tetradecyl hydrogen FDA label on DailyMed (effective August 17, 2021, Mylan Institutional LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Local reactions consisting of pain, urticaria or ulceration may occur at the site of injection. A permanent discoloration may remain along the path of the sclerosed vein segment. Sloughing and necrosis of tissue may occur following extravasation of the drug. (See WARNINGS section.) Allergic reactions such as hives, asthma, hay fever and anaphylactic shock have been reported. Mild systemic reactions that have been reported include headache, nausea and vomiting. (See WARNINGS section.) At least six deaths have been reported with the use of Sotradecol. Four cases of anaphylactic shock leading to death have been reported in patients who received Sotradecol. One of these four patients reported a history of asthma, a contraindication to the administration of Sotradecol. …

Source: FDA drug label, Mylan Institutional LLC, effective August 17, 2021 (SPL set f1756c28-dcd2-4b49-be62-07ca20682018), via openFDA; the full label on DailyMed

What do FAERS reports show?

138 reports list tetradecyl hydrogen among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 31 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Injection Site Haematoma10
  • Hypersensitivity9
  • Injection Site Discolouration9
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)8
  • Off Label Use (a use or a product term, not a reaction)7
  • Ulcer7
  • Air Embolism (named in the label)6
  • Drug Ineffective (a use or a product term, not a reaction)6
  • Erythema6
  • Injection Site Pain6
  • Anaphylactic Reaction4
  • Eschar4
  • Hypoaesthesia4
  • Loss Of Consciousness4
  • Pain4
  • Skin Necrosis4
  • Cellulitis3
  • Deep Vein Thrombosis (named in the label)3
  • Disease Progression (a use or a product term, not a reaction)3
  • Drug Ineffective For Unapproved Indication (a use or a product term, not a reaction)3
  • Fatigue3
  • Headache (named in the label)3
  • Inflammation3
  • Injection Site Ulcer3
  • Ischaemic Stroke3

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Tetradecyl hydrogen: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions