Tretinoin Side Effects: Withdrawal and Discontinuation Syndrome Explained

At a glance

  • Drug class / prescription topical retinoid [1]
  • Most common reactions / local irritation: erythema, peeling, dryness, burning, stinging, itching [1][2]
  • Renova: irritation that was severe, led to a temporary stop, or needed a mild steroid / 32% of 339 patients [1]
  • Renova: stopped for adverse reactions / about 4% [1]
  • After stopping / Retin-A cream and gel label: all adverse effects to date reversible upon discontinuance [2]
  • DEA schedule / None on the Retin-A label [2]

What the labels list instead of withdrawal

Renova's adverse reactions section lists local reactions: peeling, dry skin, burning, stinging, erythema and pruritus [1]. In its double-blind vehicle-controlled studies of 339 patients, 32% had skin irritation that was severe, led to temporary discontinuation, or led to use of a mild topical corticosteroid, and about 4% had to discontinue because of adverse reactions [1]. The Retin-A cream and gel label warns that topical use may induce severe local erythema and peeling [2].

What the labels say when irritation is too much

The Renova label says that if the degree of local irritation warrants, patients should be directed to use less medication, decrease the frequency of application, discontinue use temporarily, or discontinue use altogether and consider additional appropriate therapy [1]. The Retin-A label offers similar options: use the medication less frequently, discontinue use temporarily, or discontinue use altogether [2]. It also states that, to date, all adverse effects of Retin-A have been reversible upon discontinuance of therapy [2].

The Retin-A cream and gel label says that during the early weeks of therapy an apparent worsening of inflammatory lesions may occur and is not a reason to discontinue [2].

Stopping for pregnancy

Renova's dosing section says not to use it if the patient is pregnant, attempting to become pregnant or at high risk of pregnancy [1].

Frequently asked questions

What happens to irritation after stopping tretinoin?
The Retin-A cream and gel label states that, to date, all adverse effects of Retin-A have been reversible upon discontinuance of therapy [2]. The Renova label says that if local irritation warrants, patients should be directed to use less medication, decrease how often it is applied, stop temporarily, or stop altogether [1].
How often does irritation lead to stopping tretinoin?
In Renova studies of 339 patients, 32% had skin irritation that was severe, led to temporary discontinuation, or led to a mild topical corticosteroid, and about 4% had to discontinue because of adverse reactions [1].
Is tretinoin a controlled substance?
The Retin-A label lists the DEA schedule as None [2].

References

  1. U.S. National Library of Medicine, DailyMed. Renova tretinoin cream 0.02% (Bausch) prescribing information. Renova tretinoin cream 0.02% (Bausch) label
  2. U.S. National Library of Medicine, DailyMed. Retin-A (tretinoin) cream and gel, Bausch Health US prescribing information. Retin-A (tretinoin) cream and gel label
Evidence overview for Tretinoin Side Effects: Withdrawal and Discontinuation Syndrome Explained