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Tamsulosin Side Effects

Common Tamsulosin Side Effects


The most commonly reported Tamsulosin side effects (click to view or check a box to report):

Dizziness (106)
Product Substitution Issue (60)
Hypotension (52)
Syncope (51)
Floppy Iris Syndrome (49)
Urinary Retention (45)
Dysuria (36)
Orthostatic Hypotension (34)
Asthenia (33)
Headache (33)
Nausea (33)
Fatigue (32)
Dyspnoea (31)
Loss Of Consciousness (29)
Diarrhoea (27)
Fall (27)
Constipation (26)
Malaise (25)
Miosis (24)
Hypertension (22)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Tamsulosin Side Effects Reported to FDA

The following Tamsulosin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Tamsulosin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Persecutory Delusion
This is a report of a 72-year-old male patient (weight: NA) from JP, suffering from the following symptoms/conditions: NA, who was treated with Tamsulosin (dosage: 0.2 Mg, start time: Oct 03, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Persecutory Delusion
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tamsulosin treatment in male patients, resulting in persecutory delusion side effect.

Myocardial Infarction, Urinary Retention
This report suggests a potential Tamsulosin (tamsulosin) Myocardial Infarction, Urinary Retention side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: urinary retention,bladder disorder,urinary incontinence and used Tamsulosin (tamsulosin) (dosage: NA) starting Jul 11, 2007. Soon after starting Tamsulosin (tamsulosin) the patient began experiencing various side effects, including:
  • Myocardial Infarction
  • Urinary Retention
Drugs used concurrently:
  • Detrol La (tolterodine L-tartrate)
  • Detrol La (tolterodine L-tartrate)
  • Detrol La (tolterodine L-tartrate)
  • Flomax (tamsulosin Hydrochloride)
The patient was hospitalized. Although Tamsulosin (tamsulosin) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as myocardial infarction, may still occur.

Joint Stiffness, Protrusion Tongue, Paraesthesia, Off Label Use
This Joint Stiffness, Protrusion Tongue, Paraesthesia, Off Label Use problem was reported by a pharmacist from ES. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dysuria,hypothyroidism,depression. On 201308 this consumer started treatment with Tamsulosina (dosage: 0.4 Mg). The following drugs were being taken at the same time:
  • Eutirox
  • Topamax
  • Duloxetine
When commencing Tamsulosina, the patient experienced the following unwanted symptoms/side effects:
  • Joint Stiffness
  • Protrusion Tongue
  • Paraesthesia
  • Off Label Use
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as joint stiffness, may become evident only after a product is in use by the general population.

Hypoaesthesia Oral, Headache
This is a report of a 54-year-old male patient (weight: NA) from ES. The patient developed the following symptoms/conditions: urinary tract disorder and was treated with Tamsulosina (dosage: 0.4 Mg) starting Jul 01, 2013. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Hypoaesthesia Oral
  • Headache
This opens a possibility that Tamsulosina treatment could cause the above reactions, including hypoaesthesia oral, and some male subjects may be more susceptible.


Malaise, Labile Blood Pressure
A 89-year-old female patient (weight: NA) from FR with the following symptoms/conditions: micturition disorder,hypertension,abdominal pain started Tamsulosina treatment (dosage: 1 Df) on NS. Soon after starting Tamsulosina treatment, the subject experienced various side effects, including:
  • Malaise
  • Labile Blood Pressure
Concurrently used drugs:
  • Nisisco (hydrochlorothiazide, Valsartan) (Daily Dose:dose Per Application:80 Mg/ 12.5 Mg)
  • Laroxyl (40 Mg/ml Orally 15 Drops Once)
  • Prazepam (Daily Dose:0.5df)
  • L-thyroxine
  • Seretide
  • Stilnox
  • Movicol
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Tamsulosina.

Gingivitis
A 71-year-old male patient from JP (weight: NA) experienced symptoms, such as: NA and was treated with Tamsulosin(dosage: 0.2 Mg). The treatment was initiated on 2012. After that a consumer reported the following side effect(s):
  • Gingivitis
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Tamsulosin efficacy: NA.

Benign Prostatic Hyperplasia, Urinary Retention, Fall, Fine Motor Delay, Listless, Somnolence, Dizziness, Dry Mouth
In this report, Tamsulosina was administered for the following condition: NA.A 74-year-old male consumer from NO (weight: NA) started Tamsulosina treatment (dosage: NA) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Benign Prostatic Hyperplasia
  • Urinary Retention
  • Fall
  • Fine Motor Delay
  • Listless
  • Somnolence
  • Dizziness
  • Dry Mouth
A possible interaction with other drugs could have contributed to this reaction:
  • Lipitor (40 Mg)
  • Efexor (37.5 Mg)
  • Toviaz
  • Losartan (50 Mg)
  • Albyl-e (75 Mg)
  • Persantin (400 Mg)
  • Paracet (4 G)
  • Wellbutrin (150 Mg)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Tamsulosina treatment could be related to the listed above side effect(s).

Cystitis, Abdominal Pain, Off Label Use
This is a report of the following Tamsulosina side effect(s):
  • Cystitis
  • Abdominal Pain
  • Off Label Use
A 39-year-old female patient from KR (weight: NA) presented with the following condition: hydronephrosis,bladder dysfunction,lupus nephritis and received a treatment with Tamsulosina (dosage: Formulation: Orodispersible Cr Tablet) starting: Oct 08, 2012.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Tamsulosina treatment could be associated with the listed above side effect(s).

Respiratory Tract Congestion, Cough, Dyspnoea, Wheezing
This Tamsulosin report was submitted by a 86-year-old female consumer from US (weight: NA). The patient was diagnosed with: prostatic disorder and Tamsulosin was administered (dosage: NA) starting: Oct 27, 2011. The consumer developed a set of symptoms:
  • Respiratory Tract Congestion
  • Cough
  • Dyspnoea
  • Wheezing
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Tamsulosin treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Dizziness
This is a report of a possible correlation between Tamsulosin use and the following symptoms/side effect(s):
  • Dizziness
which could contribute to an assessment of Tamsulosin risk profile.A 67-year-old male consumer from US (weight: NA) was suffering from prostatic disorder and was treated with Tamsulosin (dosage: NA) starting Oct 24, 2011.Other concurrent medications: NA.

Erectile Dysfunction
A 64-year-old male patient from DE (weight: NA) presented with the following symptoms: NA and after a treatment with Tamsulosin (dosage: NA) experienced the following side effect(s):
  • Erectile Dysfunction
The treatment was started on NS. Tamsulosin was used in combination with the following drugs:
  • Forxiga (dapagliflozin)
  • Alpha-liponsaeure- (thioctic Acid)
  • Beofenac(aceclofenac)
  • Godamed(acetylsalicylic Acid)
  • Lyrica(pregabalin)
  • Metformin(metformin)
  • Milgamma(milgamma
  • Lantus(insulin Glargine)
This report could alert potential Tamsulosin consumers.

Erectile Dysfunction
In this report, a 64-year-old male patient from DE (weight: NA) was affected by a possible Tamsulosin side effect.The patient was diagnosed with NA. After a treatment with Tamsulosin (dosage: Daily Dose: 0.4 Mg Millgram(s) Every Days, start date: NS), the patient experienced the following side effect(s):
  • Erectile Dysfunction
The following simultaneously used drugs could have led to this reaction:
  • Forxiga
  • Alpha-liponsaeure
  • Beofenac (1-0-0-0)
  • Godamed (Daily Dose: 100 Mg Millgram(s) Every Days)
  • Lyrica (Daily Dose: 150 Mg Millgram(s) Every Days)
  • Metformin (Daily Dose: 2000 Mg Millgram(s) Every Days)
  • Milgamma /00274301/ (Daily Dose: 600 Mg Millgram(s) Every Days)
  • Lantus (0-0-0-24ie)
The findings here stress that side effects should be taken into consideration when evaluating a Tamsulosin treatment.

Dermatitis Exfoliative, Oedema Peripheral, Urticaria
This is a report of a 68-year-old male patient from SG (weight: NA), who used Tamsulosin (dosage: 400 Mcg) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Dermatitis Exfoliative
  • Oedema Peripheral
  • Urticaria
The following drugs could possibly have interacted with the Tamsulosin treatment NA.Taken together, these observations suggest that a Tamsulosin treatment could be related to side effect(s), such as Dermatitis Exfoliative, Oedema Peripheral, Urticaria.

Visual Acuity Reduced
This visual acuity reduced side effect was reported by a physician from GB. A 84-year-old male patient (weight:NA) experienced the following symptoms/conditions: prostatism. The patient was prescribed Tamsulosin (tamsulosin) (dosage: NA), which was started on Jul 23, 2013. Concurrently used drugs: NA. When starting to take Tamsulosin (tamsulosin) the consumer reported the following symptoms:
  • Visual Acuity Reduced
These side effects may potentially be related to Tamsulosin (tamsulosin).

Dizziness
This is a Tamsulosin side effect report of a 79-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: prostatic disorder, who was treated with Tamsulosin (dosage:Strength: Hcl, 0.4mg Cap Once A Day Mouth, start time: NS), combined with: NA., and developed a serious reaction and a dizziness side effect. The patient presented with:
  • Dizziness
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Tamsulosin treatment in male patients suffering from prostatic disorder, resulting in dizziness.

Visual Acuity Reduced
This report suggests a potential Tamsulosin visual acuity reduced side effect(s) that can have serious consequences. A 84-year-old male patient from GB (weight:NA) was diagnosed with the following health condition(s): prostatism and used Tamsulosin (dosage: NA) starting Jul 23, 2013. Soon after starting Tamsulosin the patient began experiencing various side effects, including:
  • Visual Acuity Reduced
Drugs used concurrently:NA. Although Tamsulosin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as visual acuity reduced, may still occur.

Visual Acuity Reduced
This visual acuity reduced problem was reported by a physician from GB. A 84-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): prostatism.On Jul 23, 2013 a consumer started treatment with Tamsulosina (dosage: 400 Mcg). The following drugs/medications were being taken at the same time: NA. When commencing Tamsulosina, the patient experienced the following unwanted symptoms /side effects:
  • Visual Acuity Reduced
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as visual acuity reduced, may become evident only after a product is in use by the general population.

Visual Acuity Reduced
This is a Tamsulosin side effect report of a 84-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: prostatism and was treated with Tamsulosin (dosage: 400 Mg, Qd) starting Jul 23, 2013. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Visual Acuity Reduced
This opens a possibility that Tamsulosin could cause visual acuity reduced and that some male patients may be more susceptible.

Ageusia, Anosmia, Constipation
A 71-year-old male patient (weight: NA) from US with the following symptoms: prostatomegaly started Tamsulosin treatment (dosage: 5-6 Wks Use) on Jun 01, 2013. Soon after starting Tamsulosin treatment, the consumer experienced several side effects, including:
  • Ageusia
  • Anosmia
  • Constipation
. Concurrently used drugs:
  • Carvedilol
  • Digoxin
  • Simvastatin
This finding indicates that some patients can be more vulnerable to developing Tamsulosin side effects, such as ageusia.

Urticaria, Rash, Psoriasis
This urticaria side effect was reported by a physician from FR. A 78-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Tamsulosin (dosage: NA), which was started on Jul 11, 2008. Concurrently used drugs:
  • Romiplostim (7mcg/kg)
  • Fluindione
.When starting to take Tamsulosin the consumer reported symptoms, such as:
  • Urticaria
  • Rash
  • Psoriasis
These side effects may potentially be related to Tamsulosin. The patient was hospitalized.

Groin Pain, Local Swelling, Joint Swelling, Arthralgia, Testicular Pain, Testicular Swelling
This is a report of a 79-year-old male patient (weight: NA) from GB, suffering from the following symptoms/conditions: urinary tract infection, who was treated with Tamsulosin (dosage: NA, start time: Jul 06, 2013), combined with:
  • Bisacodyl
  • Bisoprolol
  • Omeprazole
  • Paracetamol
  • Simvastatin
and developed a serious reaction and side effect(s). The consumer presented with:
  • Groin Pain
  • Local Swelling
  • Joint Swelling
  • Arthralgia
  • Testicular Pain
  • Testicular Swelling
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tamsulosin treatment in male patients, resulting in groin pain side effect.

Groin Pain, Local Swelling, Joint Swelling, Arthralgia, Testicular Pain, Testicular Swelling
This report suggests a potential Tamsulosin Groin Pain, Local Swelling, Joint Swelling, Arthralgia, Testicular Pain, Testicular Swelling side effect(s) that can have serious consequences. A 79-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: urinary tract obstruction and used Tamsulosin (dosage: NA) starting Jul 06, 2013. Soon after starting Tamsulosin the patient began experiencing various side effects, including:
  • Groin Pain
  • Local Swelling
  • Joint Swelling
  • Arthralgia
  • Testicular Pain
  • Testicular Swelling
Drugs used concurrently:
  • Bisacodyl (bisacodyl)
  • Bisoprolol
  • Omeprazole (omeprazole)
  • Paracetamol (paracetamol)
  • Simvastatin Tablet
Although Tamsulosin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as groin pain, may still occur.

No Adverse Event
This No Adverse Event problem was reported by a consumer or non-health professional from US. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: prostatomegaly. On May 01, 2013 this consumer started treatment with Tamsulosin (dosage: NA). The following drugs were being taken at the same time:
  • Carvedilol
  • Simvastatin
  • Digoxin
  • Baby Aspirin
  • Niacin
  • Fish Oil
  • Flax Oil
  • Multi Vit
When commencing Tamsulosin, the patient experienced the following unwanted symptoms/side effects:
  • No Adverse Event
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as no adverse event, may become evident only after a product is in use by the general population.

Testicular Pain, Testicular Swelling, Groin Pain, Local Swelling, Arthralgia, Joint Swelling
This is a report of a 79-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: urinary tract obstruction and was treated with Tamsulosin (dosage: 400 Mcg (400 Mcg, 1 In 1 D), Oral) starting Jul 06, 2013. Concurrently used drugs:
  • Bisacodyl (bisacodyl)
  • Bisoprolol (bisoprolol)
  • Omeprazole (omeprazole
  • Paracetamol (paracetamol)
  • Simvastatin (simvastatin)
Soon after that, the consumer experienced the following side effects:
  • Testicular Pain
  • Testicular Swelling
  • Groin Pain
  • Local Swelling
  • Arthralgia
  • Joint Swelling
This opens a possibility that Tamsulosin treatment could cause the above reactions, including testicular pain, and some male subjects may be more susceptible.

Bradycardia, Monoparesis, Dysaesthesia, Syncope
A 72-year-old male patient (weight: NA) from FR with the following symptoms/conditions: benign prostatic hyperplasia,cardiomyopathy started Tamsulosina treatment (dosage: 0.4 Mg) on 201301. Soon after starting Tamsulosina treatment, the subject experienced various side effects, including:
  • Bradycardia
  • Monoparesis
  • Dysaesthesia
  • Syncope
Concurrently used drugs:
  • Bumetanide (5 Mg)
  • Hytacand (1 Anz)
  • Temerit (5 Mg)
  • Cordarone (200 Mg)
  • Levothyrox (75 Mcg)
  • Previscan (1/2 Tablets Every Other Day, 3/4 Tablets Every Other Day)
  • Moprol (10 Nr)
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Tamsulosina.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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    Tamsulosin Safety Alerts, Active Ingredients, Usage Information

    NDC0093-7338
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameTamsulosin Hydrochloride
    NameTamsulosin Hydrochloride
    Dosage FormCAPSULE
    RouteORAL
    On market since20100427
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)TAMSULOSIN HYDROCHLORIDE
    Strength(s)0.4
    Unit(s)mg/1
    Pharma ClassAdrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]

    More About Tamsulosin

    Side Effects reported to FDA: 1232

    Tamsulosin safety alerts: 2005

    Reported deaths: 47

    Reported hospitalizations: 288

    Latest Tamsulosin clinical trials