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Loratadine Side Effects

Common Loratadine Side Effects


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

Dizziness (40)
Convulsion (37)
Accidental Overdose (36)
Dyspnoea (34)
Somnolence (31)
Headache (28)
Vomiting (23)
Hypersensitivity (23)
Malaise (22)
Nausea (22)
Urticaria (21)
Pain (21)
Pruritus (20)
Loss Of Consciousness (20)
Death (19)
Insomnia (19)
Syncope (19)
Palpitations (19)
Swelling Face (17)
Anxiety (17)

➢ 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.

Loratadine Side Effects Reported to FDA

The following Loratadine 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 Loratadine 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.
Constipation
This is a report of a 10-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml (dosage: NA, start time: Jul 03, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Constipation
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml treatment in male patients, resulting in constipation side effect.

Epistaxis
This report suggests a potential Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml Epistaxis side effect(s) that can have serious consequences. A 5-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml (dosage: NA) starting 201306. Soon after starting Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml the patient began experiencing various side effects, including:
  • Epistaxis
Drugs used concurrently: NA. Although Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as epistaxis, may still occur.

Disturbance In Attention, Hypersomnia, Abnormal Behaviour, Overdose
This Disturbance In Attention, Hypersomnia, Abnormal Behaviour, Overdose problem was reported by a consumer or non-health professional from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Jun 04, 2013 this consumer started treatment with Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml, the patient experienced the following unwanted symptoms/side effects:
  • Disturbance In Attention
  • Hypersomnia
  • Abnormal Behaviour
  • Overdose
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as disturbance in attention, may become evident only after a product is in use by the general population.

Eyelid Oedema, Swelling Face
This is a report of a 4-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml (dosage: NA) starting May 29, 2013. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Eyelid Oedema
  • Swelling Face
This opens a possibility that Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml treatment could cause the above reactions, including eyelid oedema, and some female subjects may be more susceptible.


Nasal Discomfort, Pain
A 34-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml treatment (dosage: NA) on May 21, 2013. Soon after starting Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml treatment, the subject experienced various side effects, including:
  • Nasal Discomfort
  • Pain
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml.

Ocular Hyperaemia, Off Label Use
A 4-year-old male patient from US (weight: NA) experienced symptoms, such as: NA and was treated with Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml(dosage: NA). The treatment was initiated on Apr 26, 2013. After that a consumer reported the following side effect(s):
  • Ocular Hyperaemia
  • Off Label Use
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml efficacy: NA.

Nasal Discomfort, Epistaxis
In this report, Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml was administered for the following condition: NA.A 35-year-old female consumer from US (weight: NA) started Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml treatment (dosage: NA) on Apr 28, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Nasal Discomfort
  • Epistaxis
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml treatment could be related to the listed above side effect(s).

Eye Movement Disorder, Screaming, Hypersensitivity
This is a report of the following Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml side effect(s):
  • Eye Movement Disorder
  • Screaming
  • Hypersensitivity
A 1-year-old female patient from US (weight: NA) presented with the following condition: sneezing and received a treatment with Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml (dosage: NA) starting: 201208.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml treatment could be associated with the listed above side effect(s).

Cough, Insomnia, Product Substitution Issue
This Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml report was submitted by a 3-year-old male consumer from US (weight: NA). The patient was diagnosed with: NA and Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Cough
  • Insomnia
  • Product Substitution Issue
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Ocular Hyperaemia, Eye Irritation, Eye Pruritus
This is a report of a possible correlation between Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml use and the following symptoms/side effect(s):
  • Ocular Hyperaemia
  • Eye Irritation
  • Eye Pruritus
which could contribute to an assessment of Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml risk profile.A 7-year-old female consumer from US (weight: NA) was suffering from NA and was treated with Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml (dosage: NA) starting Dec 18, 2012.Other concurrent medications:
  • Albuterol-proair


Accidental Overdose
A 3.-year-old male patient from US (weight: NA) presented with the following symptoms: rhinorrhoea,sneezing and after a treatment with Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml (dosage: NA) experienced the following side effect(s):
  • Accidental Overdose
The treatment was started on NS. Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml was used in combination with the following drugs: NA.This report could alert potential Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml consumers.

Vomiting
In this report, a 4-year-old female patient from US (weight: NA) was affected by a possible Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml side effect.The patient was diagnosed with rhinorrhoea,eye pruritus. After a treatment with Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml (dosage: NA, start date: Sep 22, 2012), the patient experienced the following side effect(s):
  • Vomiting
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml treatment.

Vomiting
This is a report of a 5-year-old male patient from US (weight: NA), who used Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml (dosage: NA) for a treatment of rhinorrhoea,eye pruritus. After starting a treatment on Sep 22, 2012, the patient experienced the following side effect(s):
  • Vomiting
The following drugs could possibly have interacted with the Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml treatment NA.Taken together, these observations suggest that a Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml treatment could be related to side effect(s), such as Vomiting.

Accidental Exposure To Product, Eye Pain
This accidental exposure to product side effect was reported by a consumer or non-health professional from US. A 3-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml (dosage: NA), which was started on Sep 20, 2012. Concurrently used drugs: NA. When starting to take Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml the consumer reported the following symptoms:
  • Accidental Exposure To Product
  • Eye Pain
These side effects may potentially be related to Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml.

Excoriation
This is a Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml side effect report of a 6-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml (dosage:NA, start time: Sep 18, 2012), combined with: NA., and developed a serious reaction and a excoriation side effect. The patient presented with:
  • Excoriation
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml treatment in male patients suffering from NA, resulting in excoriation.

Urticaria
This report suggests a potential Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml urticaria side effect(s) that can have serious consequences. A male patient from US (weight:NA) was diagnosed with the following health condition(s): NA and used Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml (dosage: NA) starting Aug 22, 2012. Soon after starting Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml the patient began experiencing various side effects, including:
  • Urticaria
Drugs used concurrently:NA. Although Loratadine Syrup (loratadine Oral Solution Usp) 5mg/5ml demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as urticaria, may still occur.

Glaucoma
This glaucoma problem was reported by a consumer or non-health professional from US. A 82-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Loratadine Tablets Usp (dosage: Unk Mg, Unk). The following drugs/medications were being taken at the same time: NA. When commencing Loratadine Tablets Usp, the patient experienced the following unwanted symptoms /side effects:
  • Glaucoma
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as glaucoma, may become evident only after a product is in use by the general population.

Restless Legs Syndrome
This is a Loratadine side effect report of a 56-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: seasonal allergy and was treated with Loratadine (dosage: NA) starting NS. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Restless Legs Syndrome
This opens a possibility that Loratadine could cause restless legs syndrome and that some female patients may be more susceptible.

Convulsion, Condition Aggravated
A 34-year-old female patient (weight: NA) from GB with the following symptoms: seasonal allergy started Loratadine treatment (dosage: Unk) on Jul 22, 2013. Soon after starting Loratadine treatment, the consumer experienced several side effects, including:
  • Convulsion
  • Condition Aggravated
. Concurrently used drugs:
  • Carbamazepine (800 Mg, Bid)
  • Clobazam
  • Fusidic Acid
  • Levetiracetam (1 G, Bid)
  • Paracetamol
  • Risperidone (1.5 Mg, Qd)
  • Topiramate (150 Mg, Bid)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Loratadine side effects, such as convulsion.

Convulsion, Condition Aggravated
This convulsion side effect was reported by a pharmacist from GB. A 34-year-old female patient (weight:NA) experienced the following symptoms/conditions: seasonal allergy.The patient was prescribed Loratadine (dosage: NA), which was started on Jul 22, 2013. Concurrently used drugs:
  • Levetiracetam (2 Gram Daily;)
  • Risperidone (1mg In The Morning And 500micrograms At Night.)
  • Carbamazepine (1600 Milligram Daily;)
  • Topiramate (300 Milligram Daily;)
  • Paracetamol (1g Four Times Daily As Required.)
  • Clobazam (10mg Three Times Daily As Required.)
  • Fusidic Acid
.When starting to take Loratadine the consumer reported symptoms, such as:
  • Convulsion
  • Condition Aggravated
These side effects may potentially be related to Loratadine. The patient was hospitalized.

Dyspnoea, Chest Discomfort, Abdominal Pain, Swollen Tongue, Lip Swelling, Rash
This is a report of a 47-year-old female patient (weight: NA) from AU, suffering from the following symptoms/conditions: NA, who was treated with Loratadine (dosage: 10 Mg, Once, start time: Jun 21, 2013), combined with:
  • Dexamethasone (8 Mg, Once)
  • Ranitidine (50 Mg, Once)
  • Paclitaxel (108 Mg, Once)
  • Aloxi (250 Microgram, Once)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Dyspnoea
  • Chest Discomfort
  • Abdominal Pain
  • Swollen Tongue
  • Lip Swelling
  • Rash
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Loratadine treatment in female patients, resulting in dyspnoea side effect.

Abortion Spontaneous
This report suggests a potential Loratadine Abortion Spontaneous side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: urticaria and used Loratadine (dosage: 10 Mg, Qd, During Gestational Week 10-15) starting NS. Soon after starting Loratadine the patient began experiencing various side effects, including:
  • Abortion Spontaneous
Drugs used concurrently:
  • Telfast 180 (180 Mg, Qd, During Gestational Week 0-6)
  • Folsaure (400 ?g, Qd, During Gestational Week 10-15)
  • Allergospasmin (During Gestational Week 10-15)
Although Loratadine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as abortion spontaneous, may still occur.

Abortion Spontaneous
This Abortion Spontaneous problem was reported by a physician from DE. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: urticaria. On NS this consumer started treatment with Loratadine (dosage: 10 Milligram Daily;). The following drugs were being taken at the same time:
  • Telfast 180 (168 Milligram Daily;)
  • Folsaeure (400 Microgram Daily;)
  • Allergospasmin
When commencing Loratadine, the patient experienced the following unwanted symptoms/side effects:
  • Abortion Spontaneous
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as abortion spontaneous, may become evident only after a product is in use by the general population.

Seizure Cluster, Condition Aggravated
This is a report of a 34-year-old female patient (weight: NA) from GB. The patient developed the following symptoms/conditions: seasonal allergy and was treated with Loratadine 16028/0080 10 Mg (dosage: NA) starting Jul 22, 2013. Concurrently used drugs:
  • Carbamazepine (800 Mg, Bid)
  • Clobazam (Unk)
  • Fusidic Acid
  • Levetiracetam (1 G, Bid)
  • Paracetamol (Unk)
  • Risperidone (1.5 Mg, Qd)
  • Topiramate (150 Mg, Bid)
Soon after that, the consumer experienced the following side effects:
  • Seizure Cluster
  • Condition Aggravated
The patient was hospitalized. This opens a possibility that Loratadine 16028/0080 10 Mg treatment could cause the above reactions, including seizure cluster, and some female subjects may be more susceptible.

Convulsion, Condition Aggravated
A 34-year-old female patient (weight: NA) from GB with the following symptoms/conditions: seasonal allergy started Loratadine treatment (dosage: NA) on Jul 22, 2013. Soon after starting Loratadine treatment, the subject experienced various side effects, including:
  • Convulsion
  • Condition Aggravated
Concurrently used drugs:
  • Levetiracetam (1 G, Unk)
  • Risperidone (1mg In The Morning And 500micrograms At Night.)
  • Carbamazepine (800 Mg, Bid)
  • Topiramate (150 Mg, Bid)
  • Paracetamol (Unk (1g Four Times Daily As Required))
  • Clobazam (Unk (10mg Three Times Daily As Required))
  • Fusidic Acid (Unk)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Loratadine.

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Top 10 Loratadine Side Effects for Women

Women Side EffectsReports
Dizziness 28
Dyspnoea 22
Hypersensitivity 21
Accidental Overdose 18
Headache 17
Malaise 17
Nausea 17
Pruritus 17
Syncope 16
Urticaria 15

Top 10 Loratadine Side Effects for Men

Men Side EffectsReports
Convulsion 20
Somnolence 16
Vomiting 15
Accidental Overdose 12
Dyspnoea 12
Dizziness 11
Headache 11
Overdose 10
Abdominal Pain Upper 9
Autoimmune Hepatitis 9

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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