Pharmacy Times

JULY 22, 2025

This change mirrored a January 2025 FDA safety alert and label update that urged providers to consider genetic testing, inform patients of the risks, and discuss available options. 5 In the biopharmaceutical industry, pharmacogenetics is increasingly employed to stratify patient populations and identify responders during drug development.

Compounding Pharmacies

Pharmacy Times

JULY 2, 2025

Common adverse reactions included gastrointestinal issues, with a low discontinuation rate due to adverse drug reactions. 2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis.

FDA

Pharmacy Times

JUNE 12, 2025

3 The safety profile was favorable with the most common adverse effect (AE) being increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.

FDA

Pharmacy Times

JULY 9, 2025

The FDA has approved an updated label with a new recommended titration dosing schedule for donanemab-azbt (Kisunla; Eli Lilly and Company) for once-monthly amyloid-targeting therapy for adults that experience early symptomatic Alzheimer disease (AD). million individuals in the United States aged 65 and older. 3 REFERENCES 1. News release.

Labelling

The Checkup by Singlecare

DECEMBER 12, 2024

That has led to some people taking it off-label (for a non-FDA-approved use) for weight lossat least until the FDA approved Wegovy specifically for weight loss in 2021. A compounded drug is any formulation of a drug that has not been produced by its original manufacturer under an official generic or brand-name label.

Compounding

The Checkup by Singlecare

AUGUST 6, 2025

Given that, your healthcare provider must deem it safe and beneficial for you to switch medications, and you must follow instructions for stopping Zepbound and starting Wegovy to prevent adverse reactions. Here are some typical steps to switching from a tirzepatide to a semaglutide product, such as from Zepbound to Wegovy.

Insurance

Pharmaceutical Technology

AUGUST 7, 2025

The FDA’s decision to grant accelerated approval was based on an integrated efficacy analysis of 50 patients with recurrent H3 K27M-mutant diffuse midline glioma, chosen across five open-label studies. The safety of Modeyso was evaluated in 376 patients across four open-label clinical studies.

FDA

The Checkup by Singlecare

JULY 29, 2025

Healthcare providers may also prescribe the antifungal medication off-label to treat other fungal infections , such as coccidiomycosis (Valley Fever), blastomycosis, and histoplasmosis. Daily dosing isn’t common in nail fungus treatment unless we’re dealing with a more complex or off-label use.”

Adverse Reactions

The Checkup by Singlecare

JULY 29, 2025

Plavix may also be prescribed off-label to prevent blood clots in people with atrial fibrillation. Follow dosage instructions Be sure to take the drug exactly as your healthcare provider directs, following the dosage instructions on the prescription label. It also had a lower risk of serious bleeding than aspirin did.

Adverse Reactions

The Checkup by Singlecare

JULY 3, 2025

However, healthcare providers can prescribe them “off-label” for other conditions. Compare Victoza vs. Saxenda conditions treated Condition Victoza Saxenda Type 2 diabetes Yes Off-label Obesity Off-label Yes Type 1 diabetes No No Is Saxenda better than Victoza? What conditions are treated by Victoza vs. Saxenda? Shuxiao says.

Insurance Coverage

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 16] Even more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! From indoor pollutants like formaldehyde (yes, really!),

Health and Personal Care Stores

The Checkup by Singlecare

JULY 7, 2025

Amlodipine has also been used off-label for Raynaud’s phenomenon. mg once daily to a maximum daily dose of 10 mg once daily for its FDA-approved indications of angina and chronic hypertension ; doses of up to 20 mg per day have been used in the off-label management of Raynaud phenomenon. Amlodipine doses typically range from 2.5

Insurance

The Checkup by Singlecare

AUGUST 6, 2025

In one clinical study, out of 1,393 reports of people using ivermectin, around 4% experienced serious adverse reactions. Some private plans may have different rules, but many will not pay for drugs used off-label. Six out of 25 people who took ivermectin for COVID-19 developed serious liver problems.

Insurance

The FDA Law Blog

JUNE 4, 2025

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns.

Labelling

Fierce Pharma

SEPTEMBER 28, 2023

Its label doesn't include sexual dysfunction as an adverse reaction, which is rare among antidepressants. Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium.

Adverse Reactions

STAT

JANUARY 31, 2024

and globally, for monitoring adverse reactions after a drug is on the market — one that will require extensive changes to address. Experts say that the Singulair incident highlights a flawed system, both in the U.S.

Adverse Reactions

European Pharmaceutical Review

NOVEMBER 21, 2022

The approval is based on data from two Phase III clinical trials: CADENZA, a trial for adults with CAD without having had a blood transfusion in the past six months and CARDINAL, a 26-week open label, single-arm pivotal study in patients with CAD who have had a recent blood transfusion. CADENZA Part A trial.

Adverse Reactions

European Pharmaceutical Review

OCTOBER 18, 2023

However, in the trials, the only observed adverse reaction for the treatment was diarrhoea. Most XPHOZAH-treated patients experienced mild-to-moderate reactions that resolved over time, or with dose reduction. XPHOZAH is expected to be available to eligible patients in the US in November 2023.

FDA

Pharmaceutical Technology

MAY 23, 2023

With a broad indication for indolent systemic mastocytosis and a strong label, we are now engaging healthcare providers to redefine what it means for their patients to be well-controlled, as well as activating the patient community to seek out optimal care and treatment.”

FDA

Pharmaceutical Technology

NOVEMBER 25, 2022

The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy and safety of Enhertu versus trastuzumab emtansine (T-DM1).

Adverse Reactions

European Pharmaceutical Review

NOVEMBER 30, 2022

The extension authorisation is based on an ongoing open-label, 24-week study ( NCT02881320 ), which indicated Biktarvy ® was effective and generally well-tolerated by virologically suppressed adolescents and children with HIV. After Week 48, participants could receive Biktarvy ® in an active open-label extension phase for up to 96 weeks.

Adverse Reactions

The FDA Law Blog

SEPTEMBER 23, 2022

For a number of years, FDA has been including groups of related preferred terms in tables in the Adverse Reactions Section of drug labeling (Section 6), generally describing such groupings with the use of footnotes. Such groupings have generally seemed to appear in labeling on an ad hoc basis, without standardization.

Labelling

Pharmaceutical Technology

SEPTEMBER 19, 2022

The latest development is based on findings from the single-arm, open-label Phase II/III ALD-102 (Starbeam) and Phase III ALD-104 clinical trials. Mucositis, vomiting, nausea, febrile neutropenia, alopecia and reduced appetite among others were reported to be the most prevalent non-laboratory adverse reactions reported.

FDA

PharmExec

JUNE 2, 2023

New program seeks to reduce misuse and adverse reactions by simplifying prescription labels.

Adverse Reactions

European Pharmaceutical Review

DECEMBER 23, 2022

The second group received open-label Sunlenca. The most common adverse reactions with Sunlenca were injection site reactions (swelling, pain or redness) and nausea. As part of the trial, patients were enrolled into one of two study groups. After 52 weeks, 83 percent of participants continued to have HIV RNA suppression.

FDA

European Pharmaceutical Review

SEPTEMBER 2, 2022

This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up).

Adverse Reactions

pharmaphorum

MARCH 2, 2021

Adverse reactions to the vaccine. After collecting the information, they print a plastic barcode label that can send the recipient’s vaccination records to the cloud with a simple scan. In a rollout of this magnitude, point of care facilities need to collect comprehensive vaccination data on: Individual patient records.

Vaccines

The Checkup by Singlecare

JULY 20, 2024

However, it is important to review each product’s label, and if there is any uncertainty or a need for medical advice, consult a healthcare professional first. According to the FDA’s label , its active ingredient is 10 mg of loratadine. In short, most people can safely take Claritin and ibuprofen together.

Dosage

The Checkup by Singlecare

JANUARY 13, 2023

According to the drug’s FDA label , there is no known clindamycin and alcohol interaction. Drinking alcohol while taking metronidazole can cause adverse reaction symptoms, including nausea, flushing, dizziness, palpitations, increased heart rate, and shortness of breath. .

Adverse Reactions

Pharmaceutical Technology

MARCH 28, 2023

The single-arm, multicentre, open-label trial was designed to assess the efficacy and safety of Pemazyre in 41 MLN patients with FGFR1 fusion gene positive. Diarrhoea, alopecia, stomatitis and hyperphosphataemia were the most common adverse reactions observed in patients receiving Pemazyre. in the continuously dosing population.

Adverse Reactions

The Checkup by Singlecare

FEBRUARY 8, 2024

Drug interactions | Food interactions | Other interactions | Avoiding interactions | When to see a doctor Mounjaro (tirzepatide) is gaining popularity as a treatment for Type 2 diabetes mellitus and off-label for weight management. The ones that it does have are important, though.

Labelling

The People's Pharmacy

JUNE 12, 2023

If a patient wants to report an adverse reaction to the FDA, they need to fill out Form 3500B. It is rare for pharmacies to put the expiration date on the label if they transfer the pills from the manufacturer’s original container. It requests an expiration date along with the lot number and NDC number. Why is this?”

Labelling

The People's Pharmacy

APRIL 10, 2023

You would think that the FDA would require some information on the label of PM pain relievers that warns about this paradoxical excitation reaction. You would hope that there would be some mention of such a contradictory complication on the label of OTC PM sleeping pills. Crazy, right? Natural Approaches to Insomnia?

Adverse Reactions

Pharmaceutical Technology

SEPTEMBER 7, 2022

The approval is based on findings from the global, single-arm, multicentre, registrational, open-label Phase I/II ZUMA-3 clinical trial of Tecartus to treat r/r ALL. Additionally, 25% and 32% of the subjects had Grade 3 or higher cytokine release syndrome and neurologic adverse reactions, respectively, and were found to be well managed.

Adverse Reactions

Pharmaceutical Technology

AUGUST 25, 2022

The latest approval is mainly based on positive findings from the single-arm, open-label, multicentre Phase I/II iMAGINE clinical trial of Imbruvica to treat moderate or severe cGVHD in paediatric and young adults aged one year to under 22 years. Additionally, the median duration of response was found to be 5.3

FDA

The Checkup by Singlecare

JANUARY 3, 2025

Be sure to read the labels carefully and talk to your healthcare provider about which active ingredient may be best for you, especially if you are taking other medications or supplements at the same time. In clinical trials of omeprazole , nearly 7% of participants experienced headaches as an adverse reaction.

Dosage

The Checkup by Singlecare

APRIL 14, 2024

Technically, treating animals is an off-label use for this antibacterial and antimicrobial drug, but metronidazole works for anaerobic bacteria infections, inflammatory bowel disease, giardia, acute diarrhea , and dental infections. Certain supplements, flea medications, and chemotherapy drugs may also cause adverse reactions.

Dosage