Japan · Pharmacovigilance · 使用上の注意の改訂指示
MHLW safety label changes for prescription drugs, in English: what changed in the Japanese package insert, which adverse reactions were added, and whether the US label already says the same. What a revision instruction is ↓
Last updated: 2026-09-27 · latest MHLW notice 2026-08-28 · source: PMDA/MHLW (PDL1.0), edited and translated · US labels: openFDA
45 ingredient revisions in the 3 most recent MHLW notices. Terms are our English rendering of the wording MHLW added; “JP cases” = Japanese cases cited for the change (— = not stated or not parsed). “PMDA EN?” = whether PMDA's English page lists the item. Each row links to the notice.
| Ingredient (EN / JA) | Sections changed | Key new terms (EN) | JP cases | PMDA EN? | Source |
|---|---|---|---|---|---|
| Palovarotene パロバロテン 399 Other metabolic agents | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Tucatinib ethanolate ツカチニブ エタノール付加物 429 Other antitumor agents | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Ingredient (EN / JA) | Sections changed | Key new terms (EN) | JP cases | PMDA EN? | Source |
|---|---|---|---|---|---|
| Acetaminophen アセトアミノフェン Diprophylline/dihydrocodeine phosphate/dl-methylephedrine hydrochloride/diphenhydramine hydrochloride/acetaminophen/bromovalerylurea ジプロフィリン・ジヒドロコデインリン酸塩・dl-メチルエフェドリン塩酸塩・ジフェンヒドラミンサリチル酸塩・アセトアミノフェン・ブロモバレリル尿素 Isopropylantipyrine/acetaminophen/allylisopropylacetylurea/anhydrous caffeine イソプロピルアンチピリン・アセトアミノフェン・アリルイソプロピルアセチル尿素・無水カフェイン Salicylamide/acetaminophen/anhydrous caffeine/chlorpheniramine maleate サリチルアミド・アセトアミノフェン・無水カフェイン・クロルフェニラミンマレイン酸塩 Salicylamide/acetaminophen/anhydrous caffeine/promethazine methylenedisalicylate サリチルアミド・アセトアミノフェン・無水カフェイン・プロメタジンメチレンジサリチル酸塩 Tramadol hydrochloride / acetaminophen トラマドール塩酸塩・アセトアミノフェン 114 Antipyretics, analgesics and anti-inflammatory agents; 118 Combination cold remedies; 222 Antitussives | 9 Patients with specific backgrounds | no new adverse-reaction term (wording change) | — | yes | notice list |
| Apalutamide アパルタミド 429 Other antitumor agents | 8 Important precautions 11.1 Clinically significant adverse reactions | agranulocytosis neutropenia leukopenia | 3 | yes | notice list |
| Atezolizumab (genetical recombination) アテゾリズマブ(遺伝子組換え) Avelumab (genetical recombination) アベルマブ(遺伝子組換え) Durvalumab (genetical recombination) デュルバルマブ(遺伝子組換え) Tremelimumab (genetical recombination) トレメリムマブ(遺伝子組換え) 429 Other antitumor agents | 8 Important precautions 11.1 Clinically significant adverse reactions | uveitis | 5 | yes | notice list |
| Avelumab (genetical recombination) アベルマブ(遺伝子組換え) Durvalumab (genetical recombination) デュルバルマブ(遺伝子組換え) Ipilimumab (genetical recombination) イピリムマブ(遺伝子組換え) Retifanlimab (genetical recombination) レチファンリマブ(遺伝子組換え) Tislelizumab (genetical recombination) チスレリズマブ(遺伝子組換え) Tremelimumab (genetical recombination) トレメリムマブ(遺伝子組換え) 429 Other antitumor agents | 11.1 Clinically significant adverse reactions | haemophagocytic lymphohistiocytosis | 0 | yes | notice list |
| Bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate ビクテグラビルナトリウム・エムトリシタビン・テノホビル アラフェナミドフマル酸塩 625 Antivirals | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Darunavir ethanolate / cobicistat ダルナビル エタノール付加物・コビシスタット 625 Antivirals | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Darunavir ethanolate / cobicistat / emtricitabine / tenofovir alafenamide fumarate ダルナビル エタノール付加物・コビシスタット・エムトリシタビン・テノホビル アラフェナミドフマル酸塩 625 Antivirals | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Dolutegravir sodium / rilpivirine hydrochloride ドルテグラビルナトリウム・リルピビリン塩酸塩 625 Antivirals | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Domperidone ドンペリドン 239 Other gastrointestinal agents | 8 Important precautions 11.1 Clinically significant adverse reactions | serious arrhythmia | — | yes | notice list |
| Doravirine ドラビリン 625 Antivirals | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Doravirine / islatravir hydrate ドラビリン・イスラトラビル水和物 625 Antivirals | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide fumarate エルビテグラビル・コビシスタット・エムトリシタビン・テノホビル アラフェナミドフマル酸塩 625 Antivirals | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Encorafenib エンコラフェニブ 429 Other antitumor agents | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Ipilimumab (genetical recombination) イピリムマブ(遺伝子組換え) 429 Other antitumor agents | 11.1 Clinically significant adverse reactions | haemophagocytic lymphohistiocytosis | 0 | yes | notice list |
| Ivosidenib イボシデニブ 429 Other antitumor agents | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Kakkonto 葛根湯(一般用漢方製剤) | 11.1 Clinically significant adverse reactions Other sections | erythema multiforme | 6 | yes | notice list |
| Kakkonto 葛根湯含有製剤(葛根湯エキスにジリュウエキス又はビタミン類を配合した製剤)(一般用医薬品) | 11.1 Clinically significant adverse reactions Other sections | erythema multiforme | 6 | yes | notice list |
| Kakkonto 葛根湯含有製剤(一般用医薬品) | 11.1 Clinically significant adverse reactions Other sections | erythema multiforme | 6 | yes | notice list |
| Kakkonto 葛根湯 520 Kampo preparations | 11.1 Clinically significant adverse reactions | erythema multiforme | 6 | yes | notice list |
| Lenacapavir sodium レナカパビルナトリウム 625 Antivirals | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Metoclopramide メトクロプラミド Metoclopramide hydrochloride 塩酸メトクロプラミド 239 Other gastrointestinal agents | 8 Important precautions 11.1 Clinically significant adverse reactions | serious arrhythmia | — | yes | notice list |
| Mitotane ミトタン 249 Other hormones (incl. antihormones) | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Nivolumab (genetical recombination) ニボルマブ(遺伝子組換え) 429 Other antitumor agents | 11.1 Clinically significant adverse reactions | severe oesophagitis | 15 | yes | notice list |
| Olanzapine (oral) オランザピン(経口剤) 117 Psychotropic agents; 239 Other gastrointestinal agents | 1 Warnings 2 Contraindications 9 Patients with specific backgrounds | no new adverse-reaction term (wording change) | 91 | no | notice list |
| Rilpivirine リルピビリン 625 Antivirals | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Rilpivirine hydrochloride リルピビリン塩酸塩 625 Antivirals | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Rilpivirine hydrochloride / emtricitabine / tenofovir alafenamide fumarate リルピビリン塩酸塩・エムトリシタビン・テノホビル アラフェナミドフマル酸塩 625 Antivirals | 2 Contraindications 10 Interactions | no new adverse-reaction term (wording change) | — | yes | notice list |
| Talaporfin sodium タラポルフィンナトリウム 429 Other antitumor agents | 8 Important precautions 11.1 Clinically significant adverse reactions | oesophageal perforation oesophageal stenosis | — | yes | notice list |
For each Japanese revision we search the current US prescribing information (openFDA label data) for the new term. “Not found” can mean a real Japan–US difference or just different wording — read the label before concluding.
22 of 149 new Japanese terms were not found in the current US label text, across the 122 revisions we could match to a US label (21 revisions with at least one term missing).
| JP notice | Ingredient | New term in Japan | US label? |
|---|---|---|---|
| 2026-08-25 | Apalutamide アパルタミド | agranulocytosis neutropenia leukopenia | Partly 1 of 3 terms DailyMed: ERLEADA |
| 2026-08-25 | Atezolizumab (genetical recombination) アテゾリズマブ(遺伝子組換え) | uveitis | Yes Warnings & precautions DailyMed: TECENTRIQ |
| 2026-08-25 | Avelumab (genetical recombination) アベルマブ(遺伝子組換え) | haemophagocytic lymphohistiocytosis | Yes Warnings & precautions DailyMed: Bavencio |
| + 163 more rows — every revision in the dataset, with the US label section, the quoted US wording and a DailyMed link: subscriber edition | |||
| Year | Notices | Ingredient revisions |
|---|---|---|
| 2026 (to 2026-08-28) | 17 | 167 |
| 2025 | 10 | 107 |
| 2024 (from 2024-04-09) | 10 | 124 |
| Month | Notices | Ingredients | |
|---|---|---|---|
| August 2026 | 5 | 48 | |
| July 2026 | 1 | 31 | |
| June 2026 | 3 | 12 | |
| May 2026 | 1 | 1 | |
| April 2026 | 1 | 6 | |
| March 2026 | 2 | 48 | |
| February 2026 | 3 | 12 | |
| January 2026 | 1 | 9 | |
| December 2025 | 0 | 0 | |
| November 2025 | 1 | 10 | |
| October 2025 | 1 | 11 | |
| September 2025 | 2 | 34 |
Download: monthly counts (CSV, aggregated, 24 months).
Ranked by the number of ingredients whose Japanese label gained the term (2024-04-09 to 2026-08-28).
| # | New adverse-reaction term | Ingredients | Latest notice |
|---|---|---|---|
| 1 | cerebrovascular disorder 脳血管障害 | 23 | 2024-10-08 |
| 2 | myocardial infarction 心筋梗塞 | 23 | 2024-10-08 |
| 3 | hypomagnesaemia 低マグネシウム血症 | 15 | 2026-07-14 |
| 4 | anaphylaxis アナフィラキシー | 11 | 2025-10-22 |
| 5 | vasculitis 血管炎 | 10 | 2026-07-14 |
| 6 | Kounis syndrome アレルギー反応に伴う急性冠症候群 | 7 | 2026-01-13 |
| 7 | haemophagocytic lymphohistiocytosis 血球貪食性リンパ組織球症 | 6 | 2026-08-25 |
| 8 | acute generalised exanthematous pustulosis (AGEP) 急性汎発性発疹性膿疱症 | 6 | 2026-06-16 |
| 9 | drug-induced gastrointestinal inflammatory syndrome 薬剤により誘発される胃腸炎症候群 | 6 | 2024-05-08 |
| 10 | tumour lysis syndrome 腫瘍崩壊症候群 | 5 | 2026-02-10 |
| 11 | uveitis ぶどう膜炎 | 5 | 2026-08-25 |
| 12 | autoimmune hepatitis 自己免疫性肝炎 | 4 | 2026-04-21 |
| 13 | hepatic function disorder 肝機能障害 | 4 | 2026-07-14 |
| 14 | leukopenia 白血球減少症 | 4 | 2026-08-25 |
| 15 | neutropenia 好中球減少症 | 4 | 2026-08-25 |
| Package-insert section | Revisions |
|---|---|
| 11.1 Clinically significant adverse reactions | 211 |
| 8 Important precautions | 100 |
| 10 Interactions | 81 |
| 9 Patients with specific backgrounds | 79 |
| 2 Contraindications | 75 |
| Other sections | 44 |
| 1 Warnings | 15 |
Older notices are listed as counts only (notice date and number of ingredients). The full archive — every ingredient, the wording and the US comparison — is in the subscriber edition.
Checked against PMDA's pages on 2026-09-27. Japanese source list: PMDA 使用上の注意の改訂指示通知（医薬品）. Summary for orientation only; not regulatory or medical advice.
出典：独立行政法人医薬品医療機器総合機構（PMDA）ウェブサイト「使用上の注意の改訂指示通知（医薬品）」（https://www.pmda.go.jp/safety/info-services/drugs/calling-attention/revision-of-precautions/0001.html）に掲載の厚生労働省通知を加工・翻訳して Japan Pharma Regulatory Brief が作成
Used under the Public Data License 1.0 (PDL1.0) (compatible with CC BY 4.0). The English text is an unofficial translation; the Japanese originals prevail. PMDA's own English pages are partly machine-translated and are not the authoritative text either.
Last built: .