Quick answers
- What is Bisoprolol fumarate used for?
- The FDA-approved label (Bisoprolol Fumarate, Advagen Pharma Ltd, November 12, 2025) says: “Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Bisoprolol fumarate?
- The “Adverse Reactions” section of the FDA label (Bisoprolol Fumarate, Advagen Pharma Ltd, November 12, 2025) begins: “Safety data are available in more than 30,000 patients or volunteers. Frequency estimates and rates of withdrawal of therapy for adverse events were derived from two U.S. placebo-controlled studies. In Study A, doses of 5, 10, and 20 mg bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5, 10, and 40 mg of bisoprolol fumarate were administered for 12 weeks. A total of 273 patients were treated with 5-20 mg of bisoprolol fumarate; 132 received placebo.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bisoprolol fumarate have a boxed warning?
- No. None of the 30 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Bisoprolol fumarate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bisoprolol fumarate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started October 2, 2017 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Bisoprolol fumarate?
- 23 companies list prescription products of Bisoprolol fumarate in the FDA NDC Directory, including Bryant Ranch Prepack, TruPharma, LLC and Advagen Pharma Ltd.
What Bisoprolol fumarate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.
— FDA label: Bisoprolol Fumarate, Advagen Pharma Ltd, effective November 12, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, film coated, oral), Bisoprolol Fumarate, Advagen Pharma Ltd; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 30 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 30 FDA labels for this medicine have a boxed warning.
Bisoprolol fumarate side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Safety data are available in more than 30,000 patients or volunteers. Frequency estimates and rates of withdrawal of therapy for adverse events were derived from two U.S. placebo-controlled studies. In Study A, doses of 5, 10, and 20 mg bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5, 10, and 40 mg of bisoprolol fumarate were administered for 12 weeks. A total of 273 patients were treated with 5-20 mg of bisoprolol fumarate; 132 received placebo.
Read more of this section
Withdrawal of therapy for adverse events was 3.3% for patients receiving bisoprolol fumarate and 6.8% for patients on placebo. Withdrawals were less than 1% for either bradycardia or fatigue/lack of energy. The following table presents adverse experiences, whether or not considered drug related, reported in at least 1% of patients in these studies, for all patients studied in placebo-controlled clinical trials (2.5-40 mg), as well as for a subgroup that was treated with doses within the recommended dosage range (5-20 mg). Of the adverse events listed in the table, bradycardia, diarrhea, asthenia, fatigue, and sinusitis appear to be dose related. Body System/Adverse Experience All Adverse Experiences (% a) Bisoprolol Fumarate Placebo (n=132) % 5-20 mg (n=273) % 2.5-40 mg (n=404) % a percentage of patients with event Skin increased sweating 1.5 0.7 1.0 Musculoskeletal arthralgia 2.3 2.2 2.7 Central Nervous System dizziness 3.8 2.9 3.5 headache 11.4 8.8 10.9 hypoaesthesia 0.8 1.1 1.5 Autonomic Nervous System dry mouth 1.5 0.7 1.3 Heart Rate/Rhythm bradycardia 0 0.4 0.5 Psychiatric vivid dreams 0 0 0 insomnia 2.3 1.5 2.5 depression 0.8 0 0.2 Gastrointestinal diarrhea 1.5 2.6 3.5 nausea 1.5 1.5 2.2 vomiting 0 1.1 1.5 Respiratory bronchospasm 0 0 0 cough 4.5 2.6 2.5 dyspnea 0.8 1.1 1.5 pharyngitis 2.3 2.2 2.2 rhinitis 3.0 2.9 4.0 sinusitis 1.5 2.2 2.2 URI 3.8 4.8 5.0 Body as a Whole asthenia 0 0.4 1.5 chest pain 0.8 1.1 1.5 fatigue 1.5 6.6 8.2 edema (peripheral) 3.8 3.7 3.0 The following is a comprehensive list of adverse experiences reported with bisoprolol fumarate in worldwide studies, or in postmarketing experience (in italics): Central Nervous System Dizziness, unsteadiness, vertigo, syncope, headache, paresthesia, hypoesthesia, hyperesthesia, somnolence, sleep disturbances, anxiety/restlessness, decreased concentration/memory. Autonomic Nervous System Dry mouth. Cardiovascular Bradycardia, palpitations and other rhythm disturbances, cold extremities, claudication, hypotension, orthostatic hypotension, chest pain, congestive heart failure, dyspnea on exertion. Psychiatric Vivid dreams, insomnia, depression. Gastrointestinal Gastric/epigastric/abdominal pain, gastritis, dyspepsia, nausea, vomiting, diarrhea, constipation, peptic ulcer. Musculoskeletal Muscle/joint pain, arthralgia, back/neck pain, muscle cramps, twitching/tremor. Skin Rash, acne, eczema, psoriasis, skin irritation, pruritus, flushing, sweating, alopecia, dermatitis, angioedema, exfoliative dermatitis, cutaneous vasculitis. Special Senses Visual disturbances, ocular pain/pressure, abnormal lacrimation, tinnitus, decreased hearing, earache, taste abnormalities. Metabolic Gout. Respiratory Asthma/bronchospasm, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis, URI.
— FDA label: Bisoprolol Fumarate, Advagen Pharma Ltd, effective November 12, 2025. This is part of the section. Read the full label on DailyMed →
Bisoprolol fumarate dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
The dose of bisoprolol fumarate tablets must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be an appropriate starting dose (see Bronchospastic Disease in WARNINGS). If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily.
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Patients with Renal or Hepatic Impairment In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min), the initial daily dose should be 2.5 mg and caution should be used in dose-titration. Since limited data suggest that bisoprolol fumarate is not dialyzable, drug replacement is not necessary in patients undergoing dialysis. Geriatric Patients It is not necessary to adjust the dose in the elderly, unless there is also significant renal or hepatic dysfunction (see above and Geriatric Use in PRECAUTIONS). Pediatric Patients There is no pediatric experience with bisoprolol fumarate tablets.
— FDA label: Bisoprolol Fumarate, Advagen Pharma Ltd, effective November 12, 2025. Read the full label on DailyMed →
Bisoprolol fumarate and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
Small amounts of bisoprolol fumarate (< 2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when bisoprolol fumarate is administered to nursing women.
— FDA label: Bisoprolol Fumarate, Advagen Pharma Ltd, effective November 12, 2025. Read the full label on DailyMed →
When Bisoprolol fumarate should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Bisoprolol fumarate is contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block, and marked sinus bradycardia.
— FDA label: Bisoprolol Fumarate, Advagen Pharma Ltd, effective November 12, 2025. Read the full label on DailyMed →
Bisoprolol fumarate overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
The most common signs expected with overdosage of a beta-blocker are bradycardia, hypotension, congestive heart failure, bronchospasm, and hypoglycemia. To date, a few cases of overdose (maximum: 2000 mg) with bisoprolol fumarate have been reported. Bradycardia and/or hypotension were noted. Sympathomimetic agents were given in some cases, and all patients recovered.
Read more of this section
In general, if overdose occurs, bisoprolol fumarate therapy should be stopped and supportive and symptomatic treatment should be provided. Limited data suggest that bisoprolol fumarate is not dialyzable. Based on the expected pharmacologic actions and recommendations for other beta-blockers, the following general measures should be considered when clinically warranted: Bradycardia Administer IV atropine. If the response is inadequate, isoproterenol or another agent with positive chronotropic properties may be given cautiously. Under some circumstances, transvenous pacemaker insertion may be necessary. Hypotension IV fluids and vasopressors should be administered. Intravenous glucagon may be useful. Heart Block (second or third degree) Patients should be carefully monitored and treated with isoproterenol infusion or transvenous cardiac pacemaker insertion, as appropriate. Congestive Heart Failure Initiate conventional therapy (ie, digitalis, diuretics, inotropic agents, vasodilating agents). Bronchospasm Administer bronchodilator therapy such as isoproterenol and/or aminophylline. Hypoglycemia Administer IV glucose.
— FDA label: Bisoprolol Fumarate, Advagen Pharma Ltd, effective November 12, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 49 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| bisoprolol fumarate 10 mg tablet | Generic | $0.1570 per tablet |
| bisoprolol fumarate 10 mg tablet, film coated | Generic | $0.1570 per tablet |
| bisoprolol fumarate 2.5 mg tablet, film coated | Generic | $2.48 per tablet |
| bisoprolol fumarate 5 mg tablet | Generic | $0.1150 per tablet |
| bisoprolol fumarate 5 mg tablet, film coated | Generic | $0.1150 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack7 products
- TruPharma, LLC3 products
- Advagen Pharma Ltd3 products
- NorthStar Rx LLC2 products
- Solco Healthcare US, LLC2 products
- Golden State Medical Supply, Inc.2 products
- Rising Pharma Holdings, Inc.2 products
- Aurobindo Pharma Limited2 products
- Unichem Pharmaceuticals (USA), Inc.2 products
- Alembic Pharmaceuticals Limited2 products
- Zydus Lifesciences Limited2 products
- Alembic Pharmaceuticals Inc.2 products
- Harman Finochem Limited2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Novitium Pharma LLC2 products
- Viona Pharmaceuticals Inc2 products
- Micro Labs Limited2 products
- Natco Pharma USA LLC2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- American Health Packaging1 product
- AvPAK1 product
- Proficient Rx LP1 product
- Preferred Pharmaceuticals Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (12)
- ANDA075643Rubicon Research · November 16, 2000
- ANDA075474Tp Anda Holdings · October 25, 2002
- ANDA075831Natco Pharma USA · December 14, 2005
- ANDA077910Aurobindo Pharma · December 27, 2006
- ANDA078635Unichem · August 18, 2009
- ANDA204891Alembic · January 11, 2017
- ANDA215563Novitium Pharma · October 29, 2021
- ANDA215680Zydus Lifesciences · July 25, 2022
- ANDA217368Prinston Inc · July 14, 2023
- ANDA217617Harman Finochem · January 18, 2024
- ANDA219044Unique Pharm · April 16, 2025
- ANDA218303Micro Labs · March 9, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 2, 2017 · Class II · Terminated · D-0010-2018
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbr — Unichem Pharmaceuticals Usa Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 854901, 854905, 865155 |
|---|---|
| SPL set ID of the quoted label | 83e4b4e5-9130-44c8-abab-fcd0db5d8c49 |
| FDA labels (SPL) | 30 |
| FDA applications | 12 ANDA |
| Active ingredients (FDA) | BISOPROLOL |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- High blood pressureCondition named on the label: hospitals that treat it
- Bryant Ranch PrepackMaker or distributor
- TruPharma, LLCMaker or distributor
- Advagen Pharma LtdMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Bisoprolol Fumarate, Advagen Pharma Ltd, effective November 12, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →