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Zaldiar Side Effects

Common Zaldiar Side Effects


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

Vomiting (16)
Nausea (14)
Somnolence (12)
Dizziness (9)
Hyperhidrosis (8)
Abdominal Pain (7)
Intentional Overdose (6)
Malaise (6)
International Normalised Ratio Increased (6)
Hallucination (6)
Vision Blurred (6)
Pyrexia (5)
Vertigo (5)
Dehydration (5)
Hypotension (5)
Loss Of Consciousness (5)
Hypertension (5)
Confusional State (4)
Abdominal Pain Upper (4)
Syncope (4)

➢ 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.

Zaldiar Side Effects Reported to FDA

The following Zaldiar 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 Zaldiar 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.
Hallucination, Visual, Urinary Incontinence, Hallucination, Auditory
This is a report of a 83-year-old female patient (weight: NA) from ES, suffering from the following symptoms/conditions: pain, who was treated with Zaldiar (dosage: NA, start time: May 31, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Hallucination, Visual
  • Urinary Incontinence
  • Hallucination, Auditory
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zaldiar treatment in female patients, resulting in hallucination, visual side effect.

Exposure During Pregnancy, Abortion Induced
This report suggests a potential Zaldiar Exposure During Pregnancy, Abortion Induced side effect(s) that can have serious consequences. A 39-year-old female patient (weight: NA) from CH was diagnosed with the following symptoms/conditions: nasopharyngitis and used Zaldiar (dosage: NA) starting Jul 17, 2012. Soon after starting Zaldiar the patient began experiencing various side effects, including:
  • Exposure During Pregnancy
  • Abortion Induced
Drugs used concurrently:
  • Prednisone
  • Prednisone
  • Cip Eco
  • Nasonex
  • Mucosolvan
  • Ibuprofen
  • Budesonide
  • Rinofluimucil S
Although Zaldiar demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as exposure during pregnancy, may still occur.

Gastrointestinal Mucosal Exfoliation, Abdominal Pain, Spinal Pain, Obstructive Airways Disorder, Abdominal Pain Upper, Dyspnoea, Vomiting, Chest Pain, Anxiety
This Gastrointestinal Mucosal Exfoliation, Abdominal Pain, Spinal Pain, Obstructive Airways Disorder, Abdominal Pain Upper, Dyspnoea, Vomiting, Chest Pain, Anxiety problem was reported by a physician from PT. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Nov 18, 2013 this consumer started treatment with Zaldiar (dosage: NA). The following drugs were being taken at the same time:
  • Celebrex
  • Adalgur N
  • Pantoprazole
  • Osseor
  • Calcium 600+d
When commencing Zaldiar, the patient experienced the following unwanted symptoms/side effects:
  • Gastrointestinal Mucosal Exfoliation
  • Abdominal Pain
  • Spinal Pain
  • Obstructive Airways Disorder
  • Abdominal Pain Upper
  • Dyspnoea
  • Vomiting
  • Chest Pain
  • Anxiety
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 gastrointestinal mucosal exfoliation, may become evident only after a product is in use by the general population.

Hepatic Pain, Intentional Overdose, Somnolence, Hypertension, Tachycardia
This is a report of a 16-year-old female patient (weight: NA) from FR. The patient developed the following symptoms/conditions: NA and was treated with Zaldiar (dosage: NA) starting Apr 17, 2013. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Hepatic Pain
  • Intentional Overdose
  • Somnolence
  • Hypertension
  • Tachycardia
The patient was hospitalized. This opens a possibility that Zaldiar treatment could cause the above reactions, including hepatic pain, and some female subjects may be more susceptible.


Tremor, Dizziness, Nausea, Malaise, Dry Mouth
A 73-year-old female patient (weight: NA) from ES with the following symptoms/conditions: arthralgia started Zaldiar treatment (dosage: NA) on Sep 30, 2013. Soon after starting Zaldiar treatment, the subject experienced various side effects, including:
  • Tremor
  • Dizziness
  • Nausea
  • Malaise
  • Dry Mouth
Concurrently used drugs:
  • Paracetamol
  • Chondroitin Sulfate
  • Omeprazole
  • Indapamide
This finding indicates that some female patients could be more vulnerable to Zaldiar.

Fall, Somnolence
A 83-year-old female patient from FR (weight: NA) experienced symptoms, such as: arthralgia,insomnia and was treated with Zaldiar(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Fall
  • Somnolence
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Zaldiar efficacy:
  • Stilnox
  • Zopiclone
  • Ventolin
  • Ventolin
  • Flecaine
  • Exforge
  • Previscan
The patient was hospitalized.

Rales, Somnolence, Hyponatraemia
In this report, Zaldiar was administered for the following condition: NA.A 83-year-old female consumer from FR (weight: NA) started Zaldiar treatment (dosage: NA) on Jun 27, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Rales
  • Somnolence
  • Hyponatraemia
A possible interaction with other drugs could have contributed to this reaction:
  • Lyrica
  • Lercan
  • Aerius
  • Nebilox
  • Levothyrox
  • Temesta
  • Zolpidem
  • Furosemide
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 Zaldiar treatment could be related to the listed above side effect(s).

Rash, Urinary Tract Obstruction, Cystitis Noninfective, Micturition Disorder
This is a report of the following Zaldiar side effect(s):
  • Rash
  • Urinary Tract Obstruction
  • Cystitis Noninfective
  • Micturition Disorder
A 60-year-old male patient from CH (weight: NA) presented with the following condition: back pain and received a treatment with Zaldiar (dosage: NA) starting: Nov 15, 2012.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Zaldiar treatment could be associated with the listed above side effect(s).

Convulsion, Intentional Overdose, Transaminases Increased, Vomiting
This Zaldiar report was submitted by a 19-year-old female consumer from FR (weight: NA). The patient was diagnosed with: NA and Zaldiar was administered (dosage: NA) starting: May 18, 2013. The consumer developed a set of symptoms:
  • Convulsion
  • Intentional Overdose
  • Transaminases Increased
  • Vomiting
Other drugs used simultaneously:
  • Contramal
  • Klipal Codeine
  • Prednisolone
  • Pyostacine
The patient was hospitalized.Those unexpected symptoms could be linked to a Zaldiar treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Dizziness, Hypersomnia
This is a report of a possible correlation between Zaldiar use and the following symptoms/side effect(s):
  • Dizziness
  • Hypersomnia
which could contribute to an assessment of Zaldiar risk profile.A 86-year-old female consumer from ES (weight: NA) was suffering from pain and was treated with Zaldiar (dosage: NA) starting Jun 07, 2013.Other concurrent medications: NA.

Coma, Somnolence, Confusional State, Disorientation
A 73-year-old female patient from BE (weight: NA) presented with the following symptoms: NA and after a treatment with Zaldiar (dosage: NA) experienced the following side effect(s):
  • Coma
  • Somnolence
  • Confusional State
  • Disorientation
The treatment was started on 2010. Zaldiar was used in combination with the following drugs: NA.This report could alert potential Zaldiar consumers.

Epistaxis, Haematuria, International Normalised Ratio Increased
In this report, a 62-year-old male patient from HR (weight: NA) was affected by a possible Zaldiar side effect.The patient was diagnosed with musculoskeletal pain,cardiomyopathy,stomatitis. After a treatment with Zaldiar (dosage: NA, start date: Feb 09, 2013), the patient experienced the following side effect(s):
  • Epistaxis
  • Haematuria
  • International Normalised Ratio Increased
The following simultaneously used drugs could have led to this reaction:
  • Martefarin
  • Daktarin
  • Furosemide
  • Tritace
  • Kalinor-acid
  • Lescol (fluvastatin Sodium)
  • Seretide Inhaler
  • Letizen
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Zaldiar treatment.

Suicidal Ideation, Hyperhidrosis, Hallucination
This is a report of a 78-year-old male patient from NL (weight: NA), who used Zaldiar (dosage: NA) for a treatment of pain. After starting a treatment on Jan 24, 2013, the patient experienced the following side effect(s):
  • Suicidal Ideation
  • Hyperhidrosis
  • Hallucination
The following drugs could possibly have interacted with the Zaldiar treatment
  • Acetylsalicylic Acid
  • Simvastatine Actavis
  • Spironolactone
  • Isordil
  • Ramipril
  • Dilanorm
  • Thyrax
Taken together, these observations suggest that a Zaldiar treatment could be related to side effect(s), such as Suicidal Ideation, Hyperhidrosis, Hallucination.

Gastric Ulcer, International Normalised Ratio Increased, Melaena, Hyperhidrosis, Asthenia
This gastric ulcer side effect was reported by a physician from HR. A 84-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthralgia. The patient was prescribed Zaldiar (dosage: NA), which was started on 2003. Concurrently used drugs: NA. When starting to take Zaldiar the consumer reported the following symptoms:
  • Gastric Ulcer
  • International Normalised Ratio Increased
  • Melaena
  • Hyperhidrosis
  • Asthenia
The patient was hospitalized. These side effects may potentially be related to Zaldiar.

Tumour Haemorrhage
This is a Zaldiar side effect report of a 73-year-old female patient (weight:NA) from NL, suffering from the following symptoms/conditions: myalgia, who was treated with Zaldiar (dosage:3-4 Df Per Day, start time: Feb 15, 2013), combined with:
  • Paracetamol
  • Homeopatic Preparation
, and developed a serious reaction and a tumour haemorrhage side effect. The patient presented with:
  • Tumour Haemorrhage
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Zaldiar treatment in female patients suffering from myalgia, resulting in tumour haemorrhage.

International Normalised Ratio Increased, Gastrointestinal Haemorrhage, Anaemia, Hallucination, Somnolence
This report suggests a potential Zaldiar international normalised ratio increased side effect(s) that can have serious consequences. A 80-year-old female patient from FR (weight:NA) was diagnosed with the following health condition(s): arthralgia,atrial fibrillation and used Zaldiar (dosage: NA) starting 2000. Soon after starting Zaldiar the patient began experiencing various side effects, including:
  • International Normalised Ratio Increased
  • Gastrointestinal Haemorrhage
  • Anaemia
  • Hallucination
  • Somnolence
Drugs used concurrently:
  • Previscan (fluindione)
Although Zaldiar demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as international normalised ratio increased, may still occur.

Sleep Talking, Restlessness, Confusional State, Loss Of Consciousness
This sleep talking problem was reported by a consumer or non-health professional from GR. A 95-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Zaldiar (dosage: 37.5/325 Mg, Tablet). The following drugs/medications were being taken at the same time: NA. When commencing Zaldiar, the patient experienced the following unwanted symptoms /side effects:
  • Sleep Talking
  • Restlessness
  • Confusional State
  • Loss Of Consciousness
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as sleep talking, may become evident only after a product is in use by the general population.

Lower Gastrointestinal Haemorrhage
This is a Zaldiar side effect report of a 81-year-old female patient (weight: NA) from ES. The patient developed the following symptoms/conditions: pain and was treated with Zaldiar (dosage: NA) starting 2006. Concurrently used drugs:
  • Ibuprofen
  • Acetylsalicylic Acid
  • Simvastatin
  • Enalapril Maleate
  • Omeprazole
Soon after that, the consumer experienced the following of symptoms:
  • Lower Gastrointestinal Haemorrhage
The patient was hospitalized. This opens a possibility that Zaldiar could cause lower gastrointestinal haemorrhage and that some female patients may be more susceptible.

Abdominal Pain, Vomiting, Nausea
A 92-year-old female patient (weight: NA) from FR with the following symptoms: arthralgia started Zaldiar treatment (dosage: NA) on NS. Soon after starting Zaldiar treatment, the consumer experienced several side effects, including:
  • Abdominal Pain
  • Vomiting
  • Nausea
. Concurrently used drugs:
  • Contramal
  • Augmentin
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Zaldiar side effects, such as abdominal pain.

Condition Aggravated, Haemothorax, International Normalised Ratio Increased
This condition aggravated side effect was reported by a physician from FR. A 81-year-old female patient (weight:NA) experienced the following symptoms/conditions: post-traumatic pain.The patient was prescribed Zaldiar (dosage: NA), which was started on 201112. Concurrently used drugs:
  • Previscan (fluindione)
  • Niflugel
  • Zolpidem
  • Tanganil
  • Femara
  • Levothyrox
  • Efferalgan
  • Larmabak
.When starting to take Zaldiar the consumer reported symptoms, such as:
  • Condition Aggravated
  • Haemothorax
  • International Normalised Ratio Increased
These side effects may potentially be related to Zaldiar. The patient was hospitalized.

Hepatocellular Injury
This is a report of a 90-year-old female patient (weight: NA) from CH, suffering from the following symptoms/conditions: pain, who was treated with Zaldiar (dosage: NA, start time: Dec 05, 2012), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Hepatocellular Injury
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zaldiar treatment in female patients, resulting in hepatocellular injury side effect. The patient was hospitalized.

Anxiety, Hallucination, Agitation, Malaise
This report suggests a potential Zaldiar Anxiety, Hallucination, Agitation, Malaise side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: pain and used Zaldiar (dosage: NA) starting Jun 10, 2012. Soon after starting Zaldiar the patient began experiencing various side effects, including:
  • Anxiety
  • Hallucination
  • Agitation
  • Malaise
Drugs used concurrently:
  • Lyrica
  • Lyrica
  • Prednisone
  • Diclofenac
  • Paracetamol
  • Lexomil
  • Piascledine
  • Rivotril (10 Gtt 1/day)
Although Zaldiar demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as anxiety, may still occur.

Erectile Dysfunction
This Erectile Dysfunction problem was reported by a physician from ES. A 48-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: post laminectomy syndrome. On 200912 this consumer started treatment with Zaldiar (dosage: NA). The following drugs were being taken at the same time:
  • Duloxetine Hydrochloride
  • Baclofen
  • Pregabalin
  • Clonazepam
When commencing Zaldiar, the patient experienced the following unwanted symptoms/side effects:
  • Erectile Dysfunction
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as erectile dysfunction, may become evident only after a product is in use by the general population.

Thrombocytopenia
This is a report of a 43-year-old male patient (weight: NA) from BE. The patient developed the following symptoms/conditions: back pain and was treated with Zaldiar (dosage: NA) starting Oct 24, 2012. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Thrombocytopenia
The patient was hospitalized. This opens a possibility that Zaldiar treatment could cause the above reactions, including thrombocytopenia, and some male subjects may be more susceptible.

Palatal Oedema, Tongue Oedema, Hypersensitivity
A 62-year-old male patient (weight: NA) from PT with the following symptoms/conditions: renal colic started Zaldiar treatment (dosage: NA) on Aug 21, 2009. Soon after starting Zaldiar treatment, the subject experienced various side effects, including:
  • Palatal Oedema
  • Tongue Oedema
  • Hypersensitivity
Concurrently used drugs:
  • Primperan
  • Xelevia
  • Finasteride
  • Olmetec
  • Sinvastatina
This finding indicates that some male patients could be more vulnerable to Zaldiar.

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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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    Zaldiar Safety Alerts, Active Ingredients, Usage Information

    More About Zaldiar

    Side Effects reported to FDA: 118

    Zaldiar safety alerts: No

    Reported deaths: 14

    Reported hospitalizations: 69

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