Apretude (cabotegravir extended-release injectable suspension)
Cabenuva (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension), co-packaged for intramuscular use
Vocabria (cabotegravir)
The “Adverse Reactions: Postmarketing Experience” subsection of the labeling was updated in February 2023 to include hypersensitivity reactions (including angioedema and urticaria).
Atypical antipsychotics
- Abilify (aripiprazole)
- Abilify Mycite (aripiprazole)
- Abilify Maintena (aripiprazole)
- Aristada (aripiprazole lauroxil)
- Caplyta (lumateperone)
- Clozaril (clozapine)
- Fanapt (iloperidone)
- Geodon (ziprasidone)
- Geodon (ziprasidone mesylate)
- Invega (paliperidone)
- Invega Hafyera (paliperidone palmitate)
- Invega Trinza (paliperidone palmitate)
- Latuda (lurasidone hydrochloride)
- Lybalvi (olanzapine and samidorphan)
- Nuplazid (pimavanserin)
- Rexulti (brexpiprazole)
- Risperdal (risperidone)
- Risperdal Consta (risperidone)
- Rykindo (risperidone)
- Perseris (risperidone)
- Saphris (asenapine)
- Secuado (asenapine)
- Seroquel (quetiapine)
- Seroquel XR (quetiapine)
- Symbyax (olanzapine and fluoxetine)
- Versacloz (clozapine)
- Vraylar (cariprazine)
- Zyprexa (olanzapine)
- Zyprexa Relprevv (olanzapine)
- Zyprexa Zydis (olanzapine)
The “Adverse Reactions” section of the labeling for the aripiprazole, clozapine, olanzapine, pimavanserin, and quetiapine-containing products was updated in January 2025 to include information about the risk of fecal incontinence.
Example: Abilify labeling
FDA determined that no action was necessary at the time based on available information for the other listed products.
Avonex (interferon beta-1a)
Betaseron (interferon beta-1b)
Extavia (interferon beta-1b)
Plegridy (peginterferon beta-1a)
Rebif (interferon beta-1a)
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in July 2023 to include information about the risk of pulmonary arterial hypertension.
Example: Betaseron labeling
Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid)
Prepopik (sodium picosulfate, magnesium oxide, and anhydrous citric acid)
The “Warnings and Precautions”, “Adverse Reactions”, and “Drug Interactions” sections of the labeling were updated in August 2023 to include information about syncope.
Example: Clenpiq labeling
Definity (perflutren lipid microsphere)
Lumason (sulfur hexafluoride lipid-type A microspheres)
Optison (perflutren protein-type A microspheres)
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling for Definity were updated in June 2023 to include information about the risk of inducing severe, acute pain episodes in patients with sickle cell disease.
FDA determined that no action was necessary at the time based on available information for Optison and Lumason.
Eliquis (apixaban)
Savaysa (edoxaban)
Pradaxa (dabigatran etexilate mesylate)
Xarelto (rivaroxaban)
The “Adverse Reactions” section of the Savaysa, Pradaxa, and Xarelto labeling were updated between February 2023 and November 2023 to include information about anticoagulant-related nephropathy.
Example: Pradaxa labeling
FDA determined that no action was necessary at the time based on available information for Eliquis.
Certain glipizide extended-release product (generic product for the trade name Glucotrol XL)
Certain chlorpromazine hydrochloride product (generic product)
The code imprint on a certain glipizide extended-release product was revised in March 2023 to minimize the risk of wrong drug errors.
Hydroxychloroquine sulfate
Plaquenil (hydroxychloroquine sulfate)
The “Warnings and Precautions”, “Adverse Reactions” and “Patient Counseling Information” sections of the labeling were updated between July 2023 and December 2023 to include information about the risk of hepatotoxicity in patients with porphyria cutanea tarda.
Example: Plaquenil labeling
Hydroxychloroquine sulfate
Primaquine (primaquine phosphate)
Plaquenil (hydroxychloroquine sulfate)
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in July and August 2023 to include information about neuropsychiatric symptoms.
Example: Plaquenil labeling
FDA determined that no action is necessary for Primaquine at the time based on available information.
Kalydeco (ivacaftor)
Orkambi (lumacaftor and ivacaftor)
Symdeko (tezacaftor/ivacaftor)
Trikafta (elexacaftor, tezacaftor, and ivacaftor)
FDA determined that no action was necessary at the time based on available information.
Nexletol (bempedoic acid)
Nexlizet (bempedoic acid and ezetimibe)
FDA determined that no action was necessary at the time based on available information.
Non-steroidal anti-inflammatory drugs (NSAIDs)
The “Warnings and Precautions” and “Adverse Reactions” sections of the prescription NSAID product labeling was updated in November 2024 to include information about fixed drug eruption, including generalized bullous fixed drug eruption.
Example: Feldene labeling
FDA determined that no action was necessary at the time based on available information for the nonprescription NSAID products.
Drug Safety Communication (01/19/2024): FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in January 2024 to include information about severe hypocalcemia.
In addition, FDA added a new “Boxed Warning”, and updated “Dosage and Administration” sections of the labeling to include information about severe hypocalcemia in patients with advanced chronic kidney disease and recommendations for laboratory testing prior to initiation of Prolia in these patients.
The “Boxed Warning”, “Warnings and Precautions”, “Adverse Reactions”, “Postmarketing Experience” sections of the labeling and Medication Guide were updated in October 2023 to include information about respiratory depression.
The “Warnings and Precautions” and “Patient Counseling Information” sections of the labeling were updated in July 2023 to include information about severe cutaneous adverse reactions (including Stevens-Johnson syndrome).
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"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.
Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.
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