ALFUZOSIN: 2,562 Adverse Event Reports & Safety Profile
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Drug Class: Adrenergic alpha-Antagonists [MoA] · Route: ORAL · Manufacturer: Rising Pharma Holdings, Inc. · FDA Application: 021287 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 19990127 · Latest Report: 20250910
What Are the Most Common ALFUZOSIN Side Effects?
All ALFUZOSIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Fall | 174 | 6.8% | 8 | 148 |
| Hypotension | 164 | 6.4% | 4 | 110 |
| Drug ineffective | 150 | 5.9% | 0 | 55 |
| Acute kidney injury | 113 | 4.4% | 12 | 93 |
| Dizziness | 113 | 4.4% | 0 | 32 |
| Malaise | 105 | 4.1% | 0 | 82 |
| Off label use | 91 | 3.6% | 4 | 62 |
| Dyspnoea | 82 | 3.2% | 0 | 45 |
| Neutropenia | 82 | 3.2% | 14 | 40 |
| Syncope | 81 | 3.2% | 1 | 45 |
| Thrombocytopenia | 80 | 3.1% | 5 | 51 |
| Pituitary tumour benign | 77 | 3.0% | 0 | 0 |
| Agranulocytosis | 76 | 3.0% | 0 | 61 |
| Growth hormone deficiency | 76 | 3.0% | 0 | 0 |
| Loss of consciousness | 67 | 2.6% | 1 | 35 |
| Orthostatic hypotension | 66 | 2.6% | 0 | 50 |
| Drug interaction | 64 | 2.5% | 1 | 32 |
| Hyperhidrosis | 57 | 2.2% | 10 | 28 |
| Rash | 53 | 2.1% | 2 | 34 |
| Cholestasis | 52 | 2.0% | 13 | 38 |
Who Reports ALFUZOSIN Side Effects? Age & Gender Data
Gender: 6.7% female, 93.3% male. Average age: 62.8 years. Most reports from: FR. View detailed demographics →
Is ALFUZOSIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 1 | 1 |
| 2002 | 1 | 0 | 1 |
| 2003 | 1 | 0 | 0 |
| 2004 | 4 | 0 | 0 |
| 2006 | 2 | 0 | 2 |
| 2008 | 5 | 3 | 2 |
| 2009 | 4 | 1 | 1 |
| 2010 | 8 | 0 | 2 |
| 2011 | 2 | 0 | 1 |
| 2012 | 16 | 0 | 16 |
| 2013 | 25 | 0 | 7 |
| 2014 | 81 | 8 | 47 |
| 2015 | 125 | 8 | 76 |
| 2016 | 146 | 2 | 95 |
| 2017 | 235 | 29 | 156 |
| 2018 | 232 | 43 | 109 |
| 2019 | 160 | 12 | 78 |
| 2020 | 221 | 51 | 125 |
| 2021 | 126 | 8 | 63 |
| 2022 | 131 | 0 | 51 |
| 2023 | 113 | 16 | 56 |
| 2024 | 142 | 1 | 67 |
| 2025 | 52 | 2 | 35 |
What Is ALFUZOSIN Used For?
| Indication | Reports |
|---|---|
| Benign prostatic hyperplasia | 849 |
| Product used for unknown indication | 801 |
| Urinary retention | 97 |
| Prostatomegaly | 86 |
| Prostatic disorder | 44 |
| Micturition disorder | 37 |
| Dysuria | 36 |
| Prostate cancer | 32 |
| Prostatic adenoma | 30 |
| Urinary tract disorder | 28 |
ALFUZOSIN vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Adrenergic alpha-Antagonists [MoA]
Official FDA Label for ALFUZOSIN
Official prescribing information from the FDA-approved drug label.
Drug Description
Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C 19 H 27 N 5 O 4
- HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is: The tablet also contains the following inactive ingredients: carbomer, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5.
Chemical
Structure
FDA Approved Uses (Indications)
AND USAGE Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablet is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1)
Important
Limitations of Use: Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. ( 1.1 ) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. ( 1.1 , 8.4 , 12.3 )
1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in the pediatric population.
1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in the pediatric population.
Dosage & Administration
AND ADMINISTRATION 10 mg once daily with food and with the same meal each day. ( 2 ) Tablets should not be chewed or crushed ( 2 , 12.3 ) The recommended dosage is one 10 mg alfuzosin hydrochloride extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, alfuzosin hydrochloride extended-release tablets should be taken with food and with the same meal each day. The tablets should not be chewed or crushed.
Contraindications
Alfuzosin hydrochloride extended-release tabletsare contraindicated for use: in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients [s ee Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 ) ]. with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [ see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 ) ] . in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of alfuzosin hydrochloride extended-release tablets [see Adverse Reactions ( 6.2 )]. Moderate or severe hepatic impairment ( 4 , 8.7 , 12.3 ) Coadministration with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) ( 4 , 5.4 , 7.1 , 12.3 ) Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or any of the ingredients ( 4 , 6.2 )
Known Adverse Reactions
REACTIONS Most common adverse reactions in clinical studies (incidence > 2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Unichem Pharmaceuticals (USA), Inc. at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The incidence of adverse reactions has been ascertained from 3 placebo-controlled clinical trials involving 1,608 men where daily doses of 10 and 15 mg alfuzosin were evaluated. In these 3 trials, 473 men received alfuzosin hydrochloride extended-release tablets 10 mg. In these trials, 4% of patients taking alfuzosin hydrochloride extended-release tablets 10 mg withdrew from the trial due to adverse reactions, compared with 3% in the placebo group.
Table
1 summarizes adverse reactions that occurred in > 2% of patients receiving alfuzosin hydrochloride extended-release tablets, and at a higher incidence than that of the placebo group. In general, the adverse reactions seen in long-term use were similar in type and frequency to the events described below for the 3-month trials.
Table
1 — Adverse Reactions Occurring in >2% of Alfuzosin Hydrochloride Extended-Release Tablets -Treated Patients and More Frequently than with Placebo in 3-Month Placebo-Controlled Clinical Trials Adverse Reaction Placebo ( n = 678 )
Alfuzosin Hydrochloride
Extended - Release Tablets ( n = 473 )
Dizziness
19 (2.8%) 27 (5.7%) Upper respiratory tract infection 4 (0.6%) 14 (3.0%)
Headache
12 (1.8%) 14 (3.0%)
Fatigue
12 (1.8%) 13 (2.7%) The following adverse reactions, reported by between 1% and 2% of patients receiving alfuzosin hydrochloride extended-release tablets and occurring more frequently than with placebo, are listed alphabetically by body system and by decreasing frequency within body system: Body as a whole: pain Gastrointestinal system: abdominal pain, dyspepsia, constipation, nausea Reproductive system: impotence Respiratory system: bronchitis, sinusitis, pharyngitis Signs and Symptoms of Orthostasis in Clinical Trials: The adverse reactions related to orthostasis that occurred in the double-blind phase 3 trials with alfuzosin 10 mg are summarized in Table 2.
Approximately
20% to 30% of patients in these trials were taking antihypertensive medication.
Table
2 — Number (%) of Patients with Symptoms Possibly Associated with Orthostasis in 3-Month Placebo-Controlled Clinical Trials Symptoms Placebo ( n = 678 )
Alfuzosin Hydrochloride
Extended - Release Tablets ( n = 473 )
Dizziness
19 (2.8%) 27 (5.7%) Hypotension or postural hypotension 0 2 (0.4%)
Syncope
0 1 (0.2%) Testing for blood pressure changes or orthostatic hypotension was conducted in three controlled studies. Decreased systolic blood pressure ( < 90 mm Hg, with a decrease > 20 mm Hg from baseline) was observed in none of the 674 placebo patients and 1 (0.2%) of the 469 alfuzosin hydrochloride extended-release tablets patients. Decreased diastolic blood pressure ( < 50 mm Hg, with a decrease > 15 mm Hg from baseline) was observed in 3 (0.4%) of the placebo patients and in 4 (0.9%) of the alfuzosin hydrochloride extended-release tablets patients. A positive orthostatic test (decrease in systolic blood pressure of > 20 mm Hg upon standing from the supine position) was seen in 52 (7.7%) of placebo patients and in 31 (6.6%) of the alfuzosin hydrochloride extended-release tablets patients.
6.2 Post-Marketing Experience The following adverse reactions have been identified during post approval use of alfuzosin hydrochloride extended-release tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General disorders: edema Cardiac disorders : tachycardia, chest pain, angina pectoris in patients with pre-existing coronary artery disease, atrial fibrillation Gastrointestinal disorders : diarrhea, vomiting Hepatobiliary disorders : hepatocellular and cholestatic liver injury (including cases with jaundice leading to drug discontinuation) Respiratory system disorders : rhinitis Reproductive system disorders : priapism Skin and subcutaneous tissue disorders : rash, pruritis, urticaria, angioedema, toxic epidermal necrolysis Vascular disorders : flushing Blood and lymphatic system disorders: thrombocytopenia During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in some patients on or previously treated with alpha adrenergic antagonists <span class="opacity-50 text-xs">[see Warnings and Precautions (5.6) ]</span> .
Warnings
AND PRECAUTIONS Postural hypotension/syncope: Care should be taken in patients with symptomatic hypotension or who have had a hypotensive response to other medications or are concomitantly treated with antihypertensive medication or nitrates ( 5.1 ) Use with caution in patients with severe renal impairment (creatinine clearance <30 mL/min) ( 5.2 , 8.6 , 12.3 ) Use with caution in patients with mild hepatic impairment ( 5.3 , 8.7 , 12.3 ) Should not be used in combination with other alpha adrenergic antagonists ( 5.4 , 7.2 ) Prostate carcinoma should be ruled out prior to treatment ( 5.5 )
Intraoperative Floppy Iris
Syndrome (IFIS) during cataract surgery may require modifications to the surgical technique ( 5.6) Discontinue alfuzosin hydrochloride extended-release tablets if symptoms of angina pectoris appear or worsen ( 5.8 ) Use with caution in patients with a history of QT prolongation or who are taking medications which prolong the QT interval ( 5.9 , 12.2 )
5.1 Postural Hypotension Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of alfuzosin hydrochloride extended-release tablets. As with other alpha-adrenergic antagonists, there is a potential for syncope. Patients should be warned of the possible occurrence of such events and should avoid situations where injury could result should syncope occur. There may be an increased risk of hypotension/postural hypotension and syncope when taking alfuzosin hydrochloride extended-release tablets concomitantly with anti-hypertensive medication and nitrates. Care should be taken when alfuzosin hydrochloride extended-release tablets are administered to patients with symptomatic hypotension or patients who have had a hypotensive response to other medications.
5.2 Patients with Renal Impairment Caution should be exercised when alfuzosin hydrochloride extended-release tablets are administered in patients with severe renal impairment (creatinine clearance < 30 mL/min) [ see Use in Specific Populations ( 8.6) and Clinical Pharmacology ( 12.3) ].
5.3 Patients with Hepatic Impairment Alfuzosin hydrochloride extended-release tablets are contraindicated for use in patients with moderate or severe hepatic impairment [ see Contraindications ( 4 ), Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3) ]. Although the pharmacokinetics of alfuzosin hydrochloride extended-release tablets have not been studied in patients with mild hepatic impairment, caution should be exercised when alfuzosin hydrochloride extended-release tablets are administered to such patients [ see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3) ].
5.4 Drug-Drug Interactions Potent CYP3A4 Inhibitors Alfuzosin hydrochloride extended-release tablets are contraindicated for use with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) since alfuzosin blood levels are increased [ see Contraindications ( 4 ), Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3) ]. Other alpha-adrenergic antagonists Alfuzosin hydrochloride extended-release tablets are an alpha-adrenergic antagonist and should not be used in combination with other alpha adrenergic antagonist [ see Drug Interactions ( 7.2 ) ]. Phosphodiesterase-5 (PDE5) Inhibitors PDE5-inhibitors are also vasodilators. Caution is advised for concomitant use of PDE5-inhibitors and alfuzosin hydrochloride extended-release tablets, as this combination can potentially cause symptomatic hypotension [ see Drug Interactions ( 7.4) ].
5.5 Prostatic Carcinoma Carcinoma of the prostate and benign prostatic hyperplasia (BPH) cause many of the same symptoms. These two diseases frequently coexist. Therefore, patients thought to have BPH should be examined to rule out the presence of carcinoma of the prostate prior to starting treatment with alfuzosin hydrochloride extended-release tablets.
5.6 Intraoperative Floppy Iris Syndrome (IFIS) IFIS has been observed during cataract surgery in some patients on or previously treated with alpha adrenergic antagonists. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. The patient’s ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. There does not appear to be a benefit of stopping alpha adrenergic antagonist therapy prior to cataract surgery.
5.7 Priapism Rarely (probably less than 1 in 50,000), alfuzosin, like other alpha-adrenergic antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients should be advised about the seriousness of the condition [ see Adverse Reactions ( 6.2) and Patient Counseling Information (17.3)] .
5.8 Coronary Insufficiency If symptoms of angina pectoris should appear or worsen, alfuzosin hydrochloride extended-release tablets should be discontinued.
5.9 Patients with Congenital or Acquired QT Prolongation Use with caution in patients with acquired or congenital QT prolongation or who are taking medications that prolong the QT interval <span class="opacity-50 text-xs">[see Clinical Pharmacology ( 12.2 )]</span>.
Drug Interactions
INTERACTIONS Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including alfuzosin hydrochloride extended-release tablets, can potentially cause symptomatic hypotension ( 5.4 , 7.4)