US FDA6 Oct 2026
Sertraline Hydrochloride
SERTRALINE HYDROCHLORIDE
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC · US FDA · MHRA · Saudi-Specific Annex → · Local literature →
Safety signals
Search an active substance to see the safety signals, labeling changes and safety updates three regulators have published on it — in their own words, with the official source. Where PRAC asked for a product-information update, EMA's new SmPC and package-leaflet wording opens in the entry.
1,685EMA PRAC signal assessments since 5 Sep 2012
3,262US FDA safety-related labeling changes since 6 Jan 2016
867MHRA Drug Safety Update articles since 3 Oct 2009
10 Oct 2026updated
Latest entries
US FDA2 Oct 2026
Pirtobrutinib
JAYPIRCA
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA1 Oct 2026
Entrectinib
ROZLYTREK
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA1 Oct 2026
Entrectinib
ROZLYTREK
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA30 Sep 2026
Orlistat
XENICAL
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA30 Sep 2026
Lurbinectedin
ZEPZELCA
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA30 Sep 2026
Mavacamten
CAMZYOS
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA30 Sep 2026
Procarbazine Hydrochloride
MATULANE
Labeling sections changed: Use in Specific Populations
US FDA29 Sep 2026
Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate
DELSTRIGO
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA29 Sep 2026
Doravirine
PIFELTRO
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA29 Sep 2026
Tocilizumab-Anoh
AVTOZMA
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA29 Sep 2026
Tocilizumab-Anoh
AVTOZMA
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA29 Sep 2026
Aflibercept-Boav
EYDENZELT
Labeling sections changed: Adverse Reactions
US FDA29 Sep 2026
Denosumab-Adet
PONLIMSI
Labeling sections changed: Adverse Reactions
US FDA28 Sep 2026
Rituximab-Pvvr
RUXIENCE
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA25 Sep 2026
Baricitinib
OLUMIANT
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA25 Sep 2026
Obinutuzumab
GAZYVA
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA25 Sep 2026
Argatroban
ARGATROBAN IN SODIUM CHLORIDE
Labeling sections changed: Adverse Reactions; Use in Specific Populations
US FDA24 Sep 2026
Diazepam
VALIUM
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA24 Sep 2026
Lenvatinib Mesylate
LENVIMA
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA24 Sep 2026
Belzutifan
WELIREG
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA23 Sep 2026
Paroxetine Hydrochloride
PAXIL
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA23 Sep 2026
Paroxetine Hydrochloride
PAXIL
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA23 Sep 2026
Paroxetine Hydrochloride
PAXIL CR
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA23 Sep 2026
Rosuvastatin Calcium
CRESTOR
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA23 Sep 2026
Teprotumumab-Trbw
TEPEZZA
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA22 Sep 2026
Darolutamide
NUBEQA
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA22 Sep 2026
Valsartan
PREXXARTAN
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA22 Sep 2026
Asciminib Hydrochloride
SCEMBLIX
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA21 Sep 2026
Sotatercept-Csrk
WINREVAIR
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA18 Sep 2026
Abemaciclib
VERZENIO
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA18 Sep 2026
Levacetylleucine
AQNEURSA
Labeling sections changed: Adverse Reactions; Use in Specific Populations
US FDA18 Sep 2026
Imlunestrant Tosylate
INLURIYO
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA18 Sep 2026
Palovarotene
SOHONOS
Labeling sections changed: Patient Counseling Information / Patient Information / Medication Guide
US FDA16 Sep 2026
Tofacitinib Citrate
XELJANZ
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA16 Sep 2026
Tofacitinib Citrate
XELJANZ
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA16 Sep 2026
Tofacitinib Citrate
XELJANZ XR
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA16 Sep 2026
Everolimus
ZORTRESS
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA16 Sep 2026
Finerenone
KERENDIA
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA15 Sep 2026
Tolvaptan
JYNARQUE
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
Sources and reuse
EMA European Medicines Agency
- List of signals discussed at PRAC since September 2012 (EMA/PRAC/530804/2013), with the PRAC minutes, the PRAC recommendations on signals and the new product information wording for each meeting. The wording shown in an entry is reproduced from EMA's “New product information wording – Extracts from PRAC recommendations on signals” (279 signals), with EMA's marks for added and deleted text.
© European Medicines Agency; reproduction authorised provided the source is acknowledged.
US FDA US Food and Drug Administration
- Drug Safety-related Labeling Changes (SrLC) database — the labeling sections changed by each approved supplement, from 2016.
U.S. Government work in the public domain. FDA has not reviewed or endorsed this site.
MHRA Medicines and Healthcare products Regulatory Agency
- Drug Safety Update — title and summary of each article.
Contains public sector information licensed under the Open Government Licence v3.0.
EMA entries list each PRAC meeting at which a signal was discussed; the product-information column is PRAC's own. Class signals appear under the class name EMA uses. This list does not replace a marketing authorisation holder's own signal management or literature screening; the binding text is each regulator's official publication.