BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

N/A

Manufactured by ANI Pharmaceuticals, Inc.

1,767 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE include HEADACHE, FATIGUE, DRUG INEFFECTIVE, NAUSEA, PRURITUS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE.

Top Adverse Reactions

HEADACHE49 reports
FATIGUE42 reports
DRUG INEFFECTIVE41 reports
NAUSEA41 reports
PRURITUS38 reports
PAIN37 reports
HYPERTENSION36 reports
VOMITING36 reports
RASH32 reports
DYSPNOEA31 reports
ARTHRALGIA30 reports
DIARRHOEA29 reports
HYPERSENSITIVITY28 reports
DIZZINESS27 reports
DRUG HYPERSENSITIVITY26 reports
OFF LABEL USE26 reports
ASTHENIA25 reports
DRUG INTERACTION25 reports
ABDOMINAL PAIN23 reports
INSOMNIA22 reports
PAIN IN EXTREMITY22 reports
RASH PRURITIC21 reports
ALOPECIA20 reports
CONDITION AGGRAVATED20 reports
ERYTHEMA20 reports
RENAL FAILURE ACUTE20 reports
BLOOD PRESSURE INCREASED19 reports
COUGH19 reports
MUSCULOSKELETAL STIFFNESS19 reports
PNEUMONIA19 reports
FALL18 reports
JOINT SWELLING18 reports
MALAISE18 reports
ANXIETY17 reports
ARTHROPATHY16 reports
ASPARTATE AMINOTRANSFERASE INCREASED16 reports
ATRIAL FIBRILLATION16 reports
HEPATIC ENZYME INCREASED16 reports
PERIPHERAL SWELLING16 reports
PRODUCT USE IN UNAPPROVED INDICATION16 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE16 reports
ALANINE AMINOTRANSFERASE INCREASED15 reports
DRUG INTOLERANCE15 reports
HYPOAESTHESIA15 reports
HYPOKALAEMIA15 reports
MUSCLE SPASMS15 reports
PRODUCT USE ISSUE15 reports
RHEUMATOID ARTHRITIS15 reports
SKIN ULCER15 reports
WEIGHT DECREASED15 reports
ADVERSE EVENT14 reports
ARTHRITIS14 reports
BASAL CELL CARCINOMA14 reports
CHEST PAIN14 reports
DEATH14 reports
DRUG ERUPTION14 reports
INFLAMMATION14 reports
PULMONARY FIBROSIS14 reports
ULCER14 reports
BLOOD PARATHYROID HORMONE DECREASED13 reports
BREATH SOUNDS ABNORMAL13 reports
CONFUSIONAL STATE13 reports
DEHYDRATION13 reports
FLUSHING13 reports
HEPATITIS13 reports
HYPERCALCAEMIA13 reports
INFUSION RELATED REACTION13 reports
MYOCARDIAL INFARCTION13 reports
PANNICULITIS13 reports
RED BLOOD CELL SEDIMENTATION RATE INCREASED13 reports
RHEUMATOID NODULE13 reports
SKIN NECROSIS13 reports
THERAPEUTIC PRODUCT EFFECT DECREASED13 reports
BACK PAIN12 reports
C REACTIVE PROTEIN INCREASED12 reports
DRUG TOLERANCE DECREASED12 reports
GRANULOMA SKIN12 reports
PRESCRIBED UNDERDOSE12 reports
RHEUMATOID FACTOR POSITIVE12 reports
SYNOVITIS12 reports
THERAPEUTIC RESPONSE DECREASED12 reports
TREATMENT FAILURE12 reports
ASTHMA11 reports
COMPLETED SUICIDE11 reports
CONTRAINDICATED PRODUCT ADMINISTERED11 reports
DECREASED APPETITE11 reports
FEELING ABNORMAL11 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES11 reports
MYALGIA11 reports
OEDEMA PERIPHERAL11 reports
PARAESTHESIA11 reports
URTICARIA11 reports
ANAEMIA10 reports
DEAFNESS10 reports
DYSPNOEA EXERTIONAL10 reports
FEELING COLD10 reports
GENERAL PHYSICAL HEALTH DETERIORATION10 reports
HYPONATRAEMIA10 reports
PALPITATIONS10 reports
RENAL FAILURE10 reports

Report Outcomes

Out of 606 classified reports for BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE:

Serious 72.1%Non-Serious 27.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female385 (66.0%)
Male198 (34.0%)

Reports by Age

Age 7020 reports
Age 5819 reports
Age 8115 reports
Age 7514 reports
Age 6713 reports
Age 7213 reports
Age 7413 reports
Age 6312 reports
Age 6512 reports
Age 5411 reports
Age 5611 reports
Age 6811 reports
Age 7311 reports
Age 8411 reports
Age 6110 reports
Age 7910 reports
Age 669 reports
Age 699 reports
Age 769 reports
Age 779 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE?

This profile reflects 1,767 FDA FAERS reports that mention BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE?

Frequently reported terms in FAERS include HEADACHE, FATIGUE, DRUG INEFFECTIVE, NAUSEA, PRURITUS, PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.