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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.
Malaise, Syncope
This is a report of a 67-year-old male patient (weight: NA) from FR, suffering from the following symptoms/conditions: NA, who was treated with Tamsulosin Sandoz (dosage: 1 Df, Once/single, start time: Sep 10, 2007), combined with:
  • Preterax (Unk Ukn, Q18h)
  • Crestor
  • Permixon (2 Df, Qd)
  • Inexium//esomeprazole Magnesium
and developed a serious reaction and side effect(s). The consumer presented with:
  • Malaise
  • Syncope
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tamsulosin Sandoz treatment in male patients, resulting in malaise side effect. The patient was hospitalized.

Malaise, Dizziness, Orthostatic Hypotension
This report suggests a potential Tamsulosin Sandoz Malaise, Dizziness, Orthostatic Hypotension side effect(s) that can have serious consequences. A 76-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia,hypertension and used Tamsulosin Sandoz (dosage: 1 Df, Qd) starting Aug 13, 2008. Soon after starting Tamsulosin Sandoz the patient began experiencing various side effects, including:
  • Malaise
  • Dizziness
  • Orthostatic Hypotension
Drugs used concurrently:
  • Coolmetec (1 Df, Qd)
  • Prednisone
  • Zolpidem
  • Trimetazidine
  • Doliprane
  • Mononaxy
  • Prednisolone
The patient was hospitalized. Although Tamsulosin Sandoz demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as malaise, may still occur.

Pleural Effusion
This Pleural Effusion problem was reported by a pharmacist from GB. A 82-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Tamsulosin (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Tamsulosin, the patient experienced the following unwanted symptoms/side effects:
  • Pleural Effusion
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as pleural effusion, may become evident only after a product is in use by the general population.

Pleural Effusion
This is a report of a 82-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: NA and was treated with Tamsulosin (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Pleural Effusion
This opens a possibility that Tamsulosin treatment could cause the above reactions, including pleural effusion, and some male subjects may be more susceptible.


Erection Increased
A 56-year-old male patient (weight: NA) from US with the following symptoms/conditions: urinary retention started Tamsulosin treatment (dosage: 1 Pill Once Daily Swallow) on Feb 28, 2014. Soon after starting Tamsulosin treatment, the subject experienced various side effects, including:
  • Erection Increased
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Tamsulosin.

Cytomegalovirus Gastroenteritis, Cytomegalovirus Infection
A 65-year-old male patient from COUNTRY NOT SPECIFIED (weight: NA) experienced symptoms, such as: NA and was treated with Tamsulosin(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Cytomegalovirus Gastroenteritis
  • Cytomegalovirus Infection
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Tamsulosin efficacy:
  • Starsis (nateglinide)
  • Cilostazol
  • Rabeprazole Sodium
  • Cellcept (mycophenolate Mofetil) Tablet (1500 Mg)
  • Cellcept (mycophenolate Mofetil) Tablet
  • Cellcept (mycophenolate Mofetil) Tablet
  • Ciclosporin
  • Ciclosporin
The patient was hospitalized.

Syncope
In this report, Tamsulosin (tamsulosin) was administered for the following condition: NA.A 68-year-old male consumer from IT (weight: NA) started Tamsulosin (tamsulosin) treatment (dosage: 1 Dosage Forms, 1 D, Oral) on Jan 01, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Syncope
A possible interaction with other drugs could have contributed to this reaction:
  • Ratacand Plus (0.5 Dosage Forms, 1 D, Oral)
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Tamsulosin (tamsulosin) treatment could be related to the listed above side effect(s).

Conjunctivitis
This is a report of the following Tamsulosin side effect(s):
  • Conjunctivitis
A 59-year-old male patient from US (weight: NA) presented with the following condition: benign prostatic hyperplasia and received a treatment with Tamsulosin (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Tamsulosin treatment could be associated with the listed above side effect(s).

Dermatitis Exfoliative
This Tamsulosin report was submitted by a 71-year-old male consumer from SG (weight: NA). The patient was diagnosed with: NA and Tamsulosin was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Dermatitis Exfoliative
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.

Conjunctivitis
This is a report of a possible correlation between Tamsulosin use and the following symptoms/side effect(s):
  • Conjunctivitis
which could contribute to an assessment of Tamsulosin risk profile.A 59-year-old male consumer from US (weight: NA) was suffering from benign prostatic hyperplasia and was treated with Tamsulosin (dosage: NA) starting NS.Other concurrent medications: NA.

Abdominal Pain Upper, Nausea
A 58-year-old male patient from IT (weight: NA) presented with the following symptoms: benign prostatic hyperplasia and after a treatment with Tamsulosin Hydrochloride (dosage: 0.4 Mg) experienced the following side effect(s):
  • Abdominal Pain Upper
  • Nausea
The treatment was started on Oct 08, 2013. Tamsulosin Hydrochloride was used in combination with the following drugs:
  • Levofloxacin (1 Anz)
This report could alert potential Tamsulosin Hydrochloride consumers.

Completed Suicide, Respiratory Arrest, Cardiac Arrest, Exposure Via Ingestion
In this report, a 36-year-old male patient from US (weight: NA) was affected by a possible Tamsulosin side effect.The patient was diagnosed with NA. After a treatment with Tamsulosin (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Completed Suicide
  • Respiratory Arrest
  • Cardiac Arrest
  • Exposure Via Ingestion
The following simultaneously used drugs could have led to this reaction:
  • Midazolam
  • Losartan (losartan)
  • Amlodipine (amlodipine)
  • Metoprolol (metoprolol)
  • Meclizine (meclizine) (meclizine)
  • Quinine
  • Isosorbide Dinitrate (isosorbide Dinitrate) (isosorbide Dinitrate)
  • Potassium Chloride (potassium Chloride)
The findings here stress that side effects should be taken into consideration when evaluating a Tamsulosin treatment.

Conjunctivitis, Eye Irritation, Eye Pain, Eye Discharge
This is a report of a 59-year-old male patient from US (weight: NA), who used Tamsulosin (dosage: NA) for a treatment of benign prostatic hyperplasia. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Conjunctivitis
  • Eye Irritation
  • Eye Pain
  • Eye Discharge
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 Conjunctivitis, Eye Irritation, Eye Pain, Eye Discharge.

Abdominal Distension, Dyspepsia
This abdominal distension side effect was reported by a physician from GB. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Tamsulosin Hydrochloride (dosage: Unk), which was started on Nov 06, 2013. Concurrently used drugs:
  • Ramipril (Unk)
  • Atenolol (Unk)
  • Bendroflumethiazide (Unk)
  • Co-codamol (Unk)
  • Dutasteride (Unk)
  • Omeprazole (Unk)
  • Phenoxymethylpenicillin (Unk)
  • Sildenafil (Unk)
When starting to take Tamsulosin Hydrochloride the consumer reported the following symptoms:
  • Abdominal Distension
  • Dyspepsia
These side effects may potentially be related to Tamsulosin Hydrochloride.

Dysuria, Product Substitution Issue, Condition Aggravated
This is a Tamsulosin side effect report of a 70-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: dysuria, who was treated with Tamsulosin (dosage:NA, start time: NS), combined with: NA., and developed a serious reaction and a dysuria side effect. The patient presented with:
  • Dysuria
  • Product Substitution Issue
  • Condition Aggravated
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 dysuria, resulting in dysuria.

Pleural Effusion
This report suggests a potential Tamsulosina pleural effusion side effect(s) that can have serious consequences. A 82-year-old male patient from GB (weight:NA) was diagnosed with the following health condition(s): NA and used Tamsulosina (dosage: NA) starting NS. Soon after starting Tamsulosina the patient began experiencing various side effects, including:
  • Pleural Effusion
Drugs used concurrently:NA. Although Tamsulosina demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as pleural effusion, may still occur.

Syncope
This syncope problem was reported by a pharmacist from IT. A 85-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Jan 01, 2013 a consumer started treatment with Tamsulosin Hydrochloride (dosage: NA). The following drugs/medications were being taken at the same time:
  • Carvedilol (6.25 Mg Daily)
  • Lisinopril Dihydrate (10 Mg Daily)
  • Furosemide
  • Amiodarone Hydrochloride
  • Luvion - 50 Mg Compresse - Therabel Gienne Pharma S.p.a. (25 Mg Daily)
  • Glyceryl Trinitrate (10 Mg Daily)
  • Acetylsalicylic Acid (100 Milligram Daily;)
When commencing Tamsulosin Hydrochloride, the patient experienced the following unwanted symptoms /side effects:
  • Syncope
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as syncope, may become evident only after a product is in use by the general population.

Syncope
This is a Tamsulosin Hydrochloride side effect report of a 85-year-old male patient (weight: NA) from IT. The patient developed the following symptoms/conditions: NA and was treated with Tamsulosin Hydrochloride (dosage: NA) starting Jan 01, 2013. Concurrently used drugs:
  • Carvedilol (6.25 Mg Daily)
  • Lisinopril Dihydrate (10 Mg Daily)
  • Furosemide
  • Glyceryl Trinitrate (10 Mg Daily)
  • Amiodarone Hydrochloride
  • Luvion /00252501/ (25 Mg Daily)
  • Acetylsalicylic Acid (100 Mg)
Soon after that, the consumer experienced the following of symptoms:
  • Syncope
This opens a possibility that Tamsulosin Hydrochloride could cause syncope and that some male patients may be more susceptible.

Rhinorrhoea, Dyspnoea, Headache, Rash, Pharyngeal Oedema
A 62-year-old male patient (weight: NA) from US with the following symptoms: benign prostatic hyperplasia started Tamsulosin Hcl treatment (dosage: 0.4 Mg Capsule?1 Capsule?1/day At Bedtime?by Mouth) on Mar 30, 2013. Soon after starting Tamsulosin Hcl treatment, the consumer experienced several side effects, including:
  • Rhinorrhoea
  • Dyspnoea
  • Headache
  • Rash
  • Pharyngeal Oedema
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Tamsulosin Hcl side effects, such as rhinorrhoea.

Vomiting, Pyrexia, Diarrhoea, Dry Mouth, Dizziness
This vomiting side effect was reported by a health professional from RU. A 73-year-old male patient (weight:NA) experienced the following symptoms/conditions: benign prostatic hyperplasia.The patient was prescribed Tamsulosin (dosage: 0.4 Mg), which was started on 201401. Concurrently used drugs: NA..When starting to take Tamsulosin the consumer reported symptoms, such as:
  • Vomiting
  • Pyrexia
  • Diarrhoea
  • Dry Mouth
  • Dizziness
These side effects may potentially be related to Tamsulosin.

Urinary Retention
This is a report of a 70-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Tamsulosin (flomax) (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Urinary Retention
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tamsulosin (flomax) treatment in male patients, resulting in urinary retention side effect.

Abnormal Dreams, Dry Mouth, Product Substitution Issue, Product Label On Wrong Product
This report suggests a potential Tamsulosin Abnormal Dreams, Dry Mouth, Product Substitution Issue, Product Label On Wrong Product side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia and used Tamsulosin (dosage: NA) starting NS. Soon after starting Tamsulosin the patient began experiencing various side effects, including:
  • Abnormal Dreams
  • Dry Mouth
  • Product Substitution Issue
  • Product Label On Wrong Product
Drugs used concurrently: NA. Although Tamsulosin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as abnormal dreams, may still occur.

Colonic Pseudo-obstruction
This Colonic Pseudo-obstruction problem was reported by a physician from GB. A 81-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Sep 01, 2013 this consumer started treatment with Tamsulosin (tamsulosin) (dosage: NA). The following drugs were being taken at the same time:
  • Amlodipine (amlodipine)
  • Baclofen (baclofen)
  • Citalopram (citalopram)
  • Diprobase (diprobase)
  • Epilim (valproate Sodium)
  • Ferrous Sulphate (ferrous Sulfate)
  • Folic Acid (folic Acid)
  • Furosemide (furosemide)
When commencing Tamsulosin (tamsulosin), the patient experienced the following unwanted symptoms/side effects:
  • Colonic Pseudo-obstruction
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as colonic pseudo-obstruction, may become evident only after a product is in use by the general population.

Colonic Pseudo-obstruction
This is a report of a 81-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: NA and was treated with Tamsulosin (dosage: NA) starting Sep 01, 2013. Concurrently used drugs:
  • Amlodipine (amlodipine)
  • Baclofen (baclofen)
  • Citalopram (citalopram)
  • Diprobase
  • Epilim (valproate Sodium)
  • Ferrous Sulphate
  • Folic Acid (folic Acid)
  • Furosemide (furosemide)
Soon after that, the consumer experienced the following side effects:
  • Colonic Pseudo-obstruction
The patient was hospitalized. This opens a possibility that Tamsulosin treatment could cause the above reactions, including colonic pseudo-obstruction, and some male subjects may be more susceptible.

Colonic Pseudo-obstruction
A 81-year-old male patient (weight: NA) from GB with the following symptoms/conditions: NA started Tamsulosin treatment (dosage: NA) on Sep 01, 2013. Soon after starting Tamsulosin treatment, the subject experienced various side effects, including:
  • Colonic Pseudo-obstruction
Concurrently used drugs:
  • Amlodipine
  • Baclofen
  • Citalopram
  • Diprobase /01132701/
  • Epilim
  • Ferrous Sulphate
  • Folic Acid
  • Furosemide
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Tamsulosin.

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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.


    Discuss Tamsulosin Side Effects

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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

    Flomax (tamsulosin HCl)

    Audience: Ophthalmologists, Urologists, and other healthcare professionals

    [Posted 11/22/2005] Boehringer Ingelheim and FDA notified healthcare professionals of revisions to PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information for Flomax, indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). A surgical condition termed Intraoperative Floppy Iris Syndrome (IFIS) has been observed during phacoemulsification cataract surgery in some patients treated with alpha-1 blockers including Flomax. Most of these reports were in patients taking the alpha-1 blocker when IFIS occurred, but in some cases alpha-1 blocker had been stopped prior to surgery. It is recommended that male patients being considered for cataract surgery, as part of their medical history, be specifically questioned to ascertain whether they have taken Flomax or other alpha-1 blockers. If so, the patient's ophthalmologist should be prepared for possible modifications to their surgical technique that may be warranted should IFIS be observed during the procedure.

    [November 2005 - Letter - Boehringer Ingelheim]
    [October 2005 - Label - Boehringer Ingelheim]

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