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REPORTED SIGNALS

tretinoin

Retin-A · Atralin · Renova

Registration status unknownDruginjectablesMajor Pharmaceuticals
ORAL

1 INDICATIONS AND USAGE Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin capsules are a retinoid indicated for induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL), characterized by presence of t(15;17) translocation or presence of PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.

Mechanism. 12.1 Mechanism of Action Tretinoin induces cytodifferentiation and decreased proliferation of APL cells in culture and in vivo . In APL patients, tretinoin treatment produces an initial maturation of the primitive promyelocytes derived from the leukemic clone, followed by a repopulation of the bone marrow and peripheral blood by normal, polyclonal hematopoietic cells in patients achieving complete remission (CR). The exact mechanism of action of tretinoin in APL is unknown.

FDA BOXED WARNING

FDA requires a boxed warning on this label. See full prescribing information.

Read full label →
8.579
reports (FAERS)
56.0%
reported as serious
637
fatal reports (7.4%)
30
signals above threshold
1974
first approved
2026-07
last updated
TIMELINE · FDA MILESTONES
Approved
1974
1973
2026
SIGNAL RANKING · ROR

Wat opvalt in de meldingen.

In bijsluiterNieuw signaalOnbekend & frequent
Symptoom
0.1110100
ROR [95% CI]
Differentiation Syndrome
1156.0 [981.7–1361.2]
Blepharospasm
120.5 [106.6–136.3]
Taste Disorder
39.4 [35.1–44.2]
Epilepsy
24.0 [21.3–27.0]
Gastrooesophageal Reflux Disease
10.2 [9.1–11.4]
Maternal Exposure During Pregnancy
8.9 [7.9–10.0]
Blister
8.8 [7.7–10.2]
DRUG Intolerance
8.7 [7.8–9.7]
SKIN Exfoliation
7.9 [7.0–8.9]
Migraine
7.5 [6.6–8.4]
Treatment Failure
6.6 [5.7–7.5]
ACNE
6.4 [5.6–7.4]
Intentional Product USE Issue
6.3 [5.5–7.2]
Paraesthesia
6.2 [5.6–6.9]
DRY SKIN
6.0 [5.4–6.7]

ROR = reporting odds ratio (log-schaal). Een waarde boven 1 betekent dat het symptoom vaker wordt gemeld voor dit product dan voor alle andere producten samen. Dit meet hoeveel het opvalt in meldingen — geen causaliteit, geen risico.

INTERPRETATION
Auto-gegenereerd

Tretinoïne wordt vaak gemeld in combinatie met 'maternale blootstelling tijdens zwangerschap'. Dit is logisch, omdat tretinoïne schadelijk kan zijn voor de foetus. Ook 'blaarvorming' en 'huidafschilfering' worden vaak gemeld. Dit is te verwachten, aangezien tretinoïne de huid vernieuwt en irriteert. 'Acne' wordt ook vaak gemeld; dit kan een initiële verergering zijn. 'Vaak gemeld' is niet hetzelfde als 'vaak veroorzaakt'. Dit vervangt geen medisch advies.

Dit vervangt geen medisch advies.

LABEL VERSUS REPORT
On the label

No signals currently mapped to the label.

Newly reported
Differentiation Syndrome
Blepharospasm
Taste Disorder
Epilepsy
Gastrooesophageal Reflux Disease
Maternal Exposure During Pregnancy
Blister
DRUG Intolerance
REPORTS OVER TIME

Report volume per quarter.

19741975197619771979
RECALL HISTORY · 0 ON RECORD

No recalls on record.

COMPARE WITHIN INJECTABLES
bimatoprost
Latisse · Lumigan
Reports28.372
Compare with tretinoin →
BRON & CITATIE
HealthProves. tretinoin — reported signals. Retrieved 2026-07-04. Source: openFDA (FAERS). healthproves.com/tretinoin/
FAERS8,579 records
Opgehaald2026-07-04
MethodeROR / disproportionaliteit