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Benadryl has been related to the side effect of Agitation. If you are taking Benadryl and have experienced Agitation this information may be of use to you.  
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Benadryl Drug Insert (if available)
IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.
Benadryl®(Diphenhydramine Hydrochloride Injection, USP)

BENADRYL - diphenhydramine hydrochloride injection, solution 
Parke-Davis

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Benadryl®
(Diphenhydramine Hydrochloride Injection, USP)

DESCRIPTION

Benadryl (diphenhydramine hydrochloride) is an antihistamine drug having the chemical name 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. It occurs as a white, crystalline powder, is freely soluble in water and alcohol and has a molecular weight of 291.82. The molecular formula is C17H21NO • HCl. The structural formula is as follows:

Image from Drug Label Content

Benadryl in the parenteral form is a sterile, pyrogen-free solution available in a concentration of 50 mg of diphenhydramine hydrochloride per mL. The solutions for parenteral use have been adjusted to a pH between 5.0 and 6.0 with either sodium hydroxide or hydrochloric acid. The multidose Steri-Vials® contain 0.1 mg/mL benzethonium chloride as a germicidal agent.

CLINICAL PHARMACOLOGY

Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells.

Benadryl in the injectable form has a rapid onset of action. Diphenhydramine hydrochloride is widely distributed throughout the body, including the CNS. A portion of the drug is excreted unchanged in the urine, while the rest is metabolized via the liver. Detailed information on the pharmacokinetics of Diphenhydramine Hydrochloride Injection is not available.

INDICATIONS AND USAGE

Benadryl in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when Benadryl in the oral form is impractical.

Antihistaminic

For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.

Motion sickness

For active treatment of motion sickness.

Antiparkinsonism

For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.

CONTRAINDICATIONS

Use in Neonates or Premature Infants

This drug should not be used in neonates or premature infants.

Use in Nursing Mothers

Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

Use as a Local Anesthetic

Because of the risk of local necrosis, this drug should not be used as a local anesthetic.

Antihistamines are also contraindicated in the following conditions: Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.

WARNINGS

Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction.

Local necrosis has been associated with the use of subcutaneous or intradermal use of intravenous Benadryl.

Use in Pediatric Patients

In pediatric patients, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.

As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young pediatric patient, particularly, they may produce excitation.

Use in the Elderly (approximately 60 years or older)

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

PRECAUTIONS

General

Diphenhydramine hydrochloride has an atropine-like action and, therefore, should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension. Use with caution in patients with lower respiratory disease including asthma.

Information for Patients

Patients taking diphenhydramine hydrochloride should be advised that this drug may cause drowsiness and has an additive effect with alcohol.

Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.

Drug Interactions

Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc).

MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed.

Pregnancy

Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pediatric Use

Benadryl should not be used in neonates and premature infants (see CONTRAINDICATIONS).

Benadryl may diminish mental alertness, or, in the young pediatric patient, cause excitation. Overdosage may cause hallucinations, convulsions, or death (see WARNINGS and OVERDOSAGE).

See also DOSAGE AND ADMINISTRATION section.

ADVERSE REACTIONS

The most frequent adverse reactions are underscored.

  1. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose, and throat
  2. Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles
  3. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis
  4. Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions
  5. Gl System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation
  6. GU System: Urinary frequency, difficult urination, urinary retention, early menses
  7. Respiratory System: Thickening of bronchial secretions, tightness of chest or throat and wheezing, nasal stuffiness

OVERDOSAGE

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in pediatric patients. Atropine-like signs and symptoms; dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur.

Stimulants should not be used.

Vasopressors may be used to treat hypotension.

DOSAGE AND ADMINISTRATION

THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY.

Benadryl in the injectable form is indicated when the oral form is impractical.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Pediatric Patients, other than premature infants and neonates

5 mg/kg/24 hr or 150 mg/m2/24 hr. Maximum daily dosage is 300 mg. Divide into four doses, administered intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly.

Adults

10 to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly, 100 mg if required; maximum daily dosage is 400 mg.

HOW SUPPLIED

Benadryl in parenteral form is supplied as:

Benadryl Steri-Vials®
—sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution with 0.1 mg/mL benzethonium chloride as a germicidal agent. Available in 10-mL (N 0071-4402-10) Steri-Vials.

—sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution. Available in packages of twenty-five 1-mL (N 0071-4259-13) Steri-Vials.

Benadryl Steri-Dose ®
—sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in a 1-mL disposable syringe (Steri-Dose). Available in packages of ten syringes (N 0071-4259-45).

Benadryl Ampoule
—sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in a 1-mL ampoule. Available in packages of ten (N 0071-4259-03).

Store at controlled room temperature 15°–30°C (59°–86°F). Protect from freezing and light.

Rx only

Manufactured by:
Parkedale Pharmaceuticals, Inc.
Rochester, MI 48307

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LAB-0064-3.0


BENADRYL 
diphenhydramine hydrochloride  injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0071-4259
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
Diphenhydramine Hydrochloride (Diphenhydramine) Active 50 MILLIGRAM  In 1 MILLILITER
sodium hydroxide Inactive  
hydrochloric acid Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0071-4259-13 25 VIAL In 1 PACKAGE contains a VIAL
1 1 mL (MILLILITER) In 1 VIAL This package is contained within the PACKAGE (0071-4259-13)
2 0071-4259-45 10 SYRINGE In 1 PACKAGE contains a SYRINGE
2 1 mL (MILLILITER) In 1 SYRINGE This package is contained within the PACKAGE (0071-4259-45)
3 0071-4259-03 10 AMPULE In 1 PACKAGE contains a AMPULE
3 1 mL (MILLILITER) In 1 AMPULE This package is contained within the PACKAGE (0071-4259-03)

BENADRYL 
diphenhydramine hydrochloride  injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0071-4402
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
Diphenhydramine Hydrochloride (Diphenhydramine) Active 50 MILLIGRAM  In 1 MILLILITER
sodium hydroxide Inactive  
hydrochloric acid Inactive  
benzethonium chloride Inactive 0.1 MILLIGRAM  In 1 MILLILITER
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0071-4402-10 10 mL (MILLILITER) In 1 VIAL None

Revised: 05/2006Parke-Davis
Benadryl Ingredients
  • Diphenhydramine
  • Diphenhydramine hydrochloride
  • Diphenhydraminum
  • Difenidrammina
  • Difenhidramina
    • Benadryl - Agitation Outcomes
  • Recovered without sequelae - 66 Reported Cases
  • Unknown - 13 Reported Cases
  • Not yet recovered - 8 Reported Cases
  • - 7 Reported Cases
  • Recovered with sequelae - 4 Reported Cases
  • Died drug may be contributory - 2 Reported Cases
    • Benadryl - Agitation Involvements
  • Treatment - 72 Reported Cases
  • Concomitant - 22 Reported Cases
  • Suspected - 6 Reported Cases
    • Other Reactions Reported While Taking Benadryl
    pruritus - 3262 Reports rash - 3085 Reports urticaria - 2115 Reports itching - 1399 Reports
    hives - 1246 Reports rash erythematous - 1159 Reports erythema - 1078 Reports rash maculo-papular - 1053 Reports
    flushing - 964 Reports face oedema - 730 Reports nausea - 661 Reports dyspnoea - 630 Reports
    fever - 574 Reports breath shortness - 486 Reports oedema periorbital - 479 Reports anaphylactoid reaction - 476 Reports
    allergic reaction - 460 Reports vomiting - 455 Reports hypotension - 445 Reports oedema - 367 Reports
    lips swelling non-specific - 340 Reports angioedema - 322 Reports chest tightness of - 319 Reports tachycardia - 306 Reports
    dizziness - 295 Reports breathing difficult - 295 Reports paraesthesia - 284 Reports throat tightness - 266 Reports
    coughing - 261 Reports injection site reaction - 248 Reports anaphylactic reaction - 244 Reports headache - 237 Reports
    chills - 236 Reports tongue oedema - 229 Reports chest pain - 225 Reports bronchospasm - 215 Reports
    throat swelling non-specific - 188 Reports pain - 181 Reports tongue swelling non-specific - 175 Reports abdominal pain - 160 Reports
    wheezes - 158 Reports back pain - 157 Reports shaking - 150 Reports hypertension - 149 Reports
    oedema peripheral - 146 Reports sneezing excessive - 141 Reports swallowing difficult - 138 Reports sweating increased - 135 Reports
    oedema mouth - 135 Reports diarrhoea - 131 Reports dysphagia - 120 Reports pulse rate increased - 119 Reports
    blood pressure increased - 118 Reports nasal congestion - 117 Reports conjunctivitis - 114 Reports rigors - 112 Reports
    anxiety - 111 Reports arthralgia - 110 Reports throat irritation - 108 Reports eyelid oedema - 105 Reports
    burning sensation - 104 Reports tremor - 103 Reports diaphoresis - 103 Reports respiratory disorder - 100 Reports
    agitation - 100 Reports malaise - 96 Reports cyanosis - 94 Reports erythema multiforme - 91 Reports
    papular rash - 89 Reports oedema of extremities - 88 Reports tingling skin - 87 Reports feeling of warmth - 86 Reports
    pallor - 82 Reports larynx oedema - 81 Reports macular rash - 77 Reports faintness - 75 Reports
    confusion - 73 Reports asthenia - 71 Reports palpitation - 69 Reports fatigue - 68 Reports
    serum sickness - 67 Reports swelling non-inflammatory - 67 Reports throat sore - 66 Reports speech disorder - 65 Reports
    weakness generalized - 65 Reports anaphylactic shock - 63 Reports anaphylaxis - 62 Reports stevens johnson syndrome - 61 Reports
    dystonia - 59 Reports tongue thick - 58 Reports feeling unwell - 58 Reports blisters - 58 Reports
    bullous eruption - 56 Reports vision blurred - 55 Reports unconsciousness - 55 Reports respiratory distress - 55 Reports
    convulsions - 54 Reports hypersensitivity - 54 Reports mouth dry - 53 Reports leukocytosis - 53 Reports
    joint pain - 53 Reports pharyngitis - 52 Reports sgot increased - 51 Reports oedema generalised - 51 Reports
    drowsiness - 51 Reports oedema dependent - 51 Reports hot flushes - 50 Reports myalgia - 49 Reports
    wheals - 46 Reports eye irritation - 46 Reports laryngismus - 44 Reports numbness localized - 44 Reports
    hypoxaemia - 44 Reports oedema legs - 43 Reports light-headed feeling - 43 Reports syncope - 42 Reports
    chest discomfort - 42 Reports rash purpuric - 42 Reports cramp abdominal - 42 Reports numbness - 42 Reports
    skin discolouration - 41 Reports creatinine blood increased - 41 Reports sgpt increased - 41 Reports blood pressure drop arterial - 41 Reports
    stridor - 40 Reports dermatitis - 39 Reports injection site pain - 39 Reports hypoxia - 39 Reports
    bradycardia - 38 Reports lethargy - 38 Reports skin warm - 38 Reports extrapyramidal disorder - 37 Reports
    rhinitis - 37 Reports joint swelling non-inflammatory - 37 Reports numbness oral - 37 Reports shivering - 36 Reports
    hoarseness - 35 Reports injection site inflammation - 34 Reports thrombocytopenia - 34 Reports condition aggravated - 33 Reports
    tingling mucosal - 33 Reports efficacy, lack of - 33 Reports hypoaesthesia - 32 Reports petechiae - 32 Reports
    temperature elevation - 32 Reports consciousness decreased - 32 Reports tachypnoea - 31 Reports application site reaction - 31 Reports
    skin cold clammy - 31 Reports insomnia - 31 Reports irritability - 31 Reports muscle stiffness - 31 Reports
    tongue disorder - 30 Reports abdominal discomfort - 30 Reports burning skin - 30 Reports eruption - 30 Reports
    chest pressure sensation of - 30 Reports twitching - 28 Reports stomatitis - 28 Reports disorientation - 27 Reports
    eosinophilia - 27 Reports oedema pharynx - 27 Reports respiratory rate increased - 27 Reports choking - 27 Reports
    haemoglobin decreased - 27 Reports leucopenia - 26 Reports muscle rigidity - 25 Reports muscle spasticity - 25 Reports
    cardiac arrest - 25 Reports voice alteration - 25 Reports torticollis - 25 Reports throat dry - 25 Reports
    vision abnormal - 25 Reports lacrimation abnormal - 25 Reports blood pressure high - 25 Reports akathisia - 24 Reports
    skin disorder - 24 Reports bilirubin increased - 24 Reports restlessness marked - 24 Reports hallucination - 23 Reports
    oculogyric crisis - 23 Reports walking difficulty - 23 Reports photosensitivity reaction - 22 Reports vasculitis - 22 Reports
    neutropenia - 22 Reports somnolence - 22 Reports skin dry - 22 Reports skin peeling - 22 Reports
    trismus - 21 Reports asthma - 21 Reports urinary incontinence - 21 Reports pain neck/shoulder - 21 Reports
    sensation of warmth - 21 Reports skin flushed - 21 Reports tongue protrusion spastic involun - 20 Reports purpura - 20 Reports
    jaundice - 20 Reports tinnitus - 19 Reports ldh increased - 19 Reports coma - 19 Reports
    emesis - 19 Reports eye inflamed - 19 Reports feeling strange - 19 Reports oedema nos - 19 Reports
    anorexia - 18 Reports lymphadenopathy - 18 Reports dyskinesia - 18 Reports hyperventilation - 18 Reports
    eye abnormality - 18 Reports bruise - 18 Reports pneumonia - 18 Reports paraesthesia mouth - 18 Reports
    shock - 17 Reports respiratory arrest - 17 Reports saliva increased - 17 Reports joint stiffness - 17 Reports
    therapeutic response decreased - 17 Reports hepatic enzymes increased - 17 Reports dehydration - 17 Reports stomach upset - 17 Reports
    rash petechial - 17 Reports hypertonia - 16 Reports tongue pain - 16 Reports renal failure acute - 16 Reports
    myocardial infarction - 16 Reports burning mucosal - 16 Reports skin exfoliation - 16 Reports leg pain - 16 Reports
    epigastric pain not food-related - 16 Reports feeling cold - 16 Reports retching - 16 Reports rash pustular - 15 Reports
    stupor - 15 Reports laryngotracheal oedema - 15 Reports crying abnormal - 15 Reports nervousness - 15 Reports
    ankle oedema - 15 Reports morbilliform rash - 15 Reports alkaline phosphatase serum incr - 15 Reports skin reaction localised - 15 Reports
    medication error - 15 Reports bun increased - 14 Reports dyspepsia - 14 Reports inflammation localized - 14 Reports
    urinary retention - 14 Reports depression - 14 Reports drug level increased - 14 Reports muscle ache - 14 Reports
    blood pressure fluctuation - 14 Reports temperature changed sensation - 14 Reports muscle pain - 14 Reports airways obstruction - 14 Reports
    blood sugar increased - 14 Reports dermatitis exfoliative - 13 Reports arthritis - 13 Reports phosphatase alkaline increased - 13 Reports
    hypothermia - 13 Reports eye pain - 13 Reports vasodilatation - 13 Reports anaemia - 13 Reports
    cyanosis peripheral - 13 Reports toxic epidermal necrolysis - 13 Reports rash bullous - 13 Reports gamma-gt increased - 13 Reports
    fall - 13 Reports heartburn - 13 Reports slurred speech - 13 Reports respiratory depression - 12 Reports
    faecal incontinence - 12 Reports dysphasia - 12 Reports muscle weakness - 12 Reports infection - 12 Reports
    herpes simplex - 12 Reports panic reaction - 12 Reports influenza-like symptoms - 12 Reports red eye - 12 Reports
    laryngeal oedema - 12 Reports sinus congestion - 12 Reports joint inflammation - 12 Reports mouth ulceration - 12 Reports
    drug eruption - 12 Reports weight decrease - 12 Reports laryngospasm - 12 Reports hyperglycaemia - 11 Reports
    vertigo - 11 Reports phlebitis - 11 Reports cellulitis - 11 Reports arthrosis - 11 Reports
    pulse weak - 11 Reports paraesthesia mucosal - 11 Reports pulmonary congestion - 11 Reports vesicular rash - 11 Reports
    pain burning - 11 Reports spasms - 11 Reports tiredness - 11 Reports nose congestion - 11 Reports
    arrhythmia - 10 Reports dysarthria - 10 Reports renal function abnormal - 10 Reports cramps legs - 10 Reports
    photophobia - 10 Reports rash scaly - 10 Reports gait unsteady - 10 Reports urine discolouration - 10 Reports
    esr increased - 10 Reports hyperaemia eye - 10 Reports liver function tests abnormal nos - 10 Reports swallowing impaired - 10 Reports
    neutrophilia - 10 Reports coombs direct test positive - 10 Reports crohn's disease aggravated - 10 Reports feeling hot and cold - 10 Reports
    apnoea - 9 Reports dermatitis contact - 9 Reports opisthotonos - 9 Reports psychosis - 9 Reports
    laryngitis - 9 Reports hepatitis - 9 Reports heart disorder - 9 Reports pulmonary oedema - 9 Reports
    stools loose - 9 Reports sputum increased - 9 Reports arthropathy - 9 Reports delirium - 9 Reports
    dermatitis allergic - 9 Reports serum sickness-like disorder - 9 Reports sepsis - 9 Reports collapse transient - 9 Reports
    jaw stiffness - 9 Reports pulse rate decrease marked - 9 Reports mottled skin - 9 Reports passed out - 9 Reports
    wbc abnormal nos - 9 Reports asthma aggravated - 9 Reports appetite decreased - 9 Reports sleepiness - 9 Reports
    mouth irritation - 9 Reports angioneurotic oedema - 9 Reports constipation - 9 Reports non-accidental overdose - 9 Reports
    ataxia - 8 Reports dysuria - 8 Reports angina pectoris - 8 Reports death - 8 Reports
    dysphonia - 8 Reports hallucination visual - 8 Reports aggressive reaction - 8 Reports balance difficulty - 8 Reports
    oedema genital - 8 Reports haematuria - 8 Reports head discomfort - 8 Reports gait abnormal - 8 Reports
    fibrillation atrial - 8 Reports abdominal distension - 8 Reports taste metallic - 8 Reports vasovagal reaction - 8 Reports
    discomfort bodily - 8 Reports pyrexia - 8 Reports ecchymosis - 8 Reports temperature body decrease - 8 Reports
    bone pain - 8 Reports creatine kinase increased - 8 Reports intestinal obstruction - 8 Reports vision decreased - 8 Reports
    jaw pain - 8 Reports abdominal pain upper - 7 Reports hypokalaemia - 7 Reports eczema - 7 Reports
    hypokinesia - 7 Reports sinusitis - 7 Reports hepatic failure - 7 Reports bilirubinaemia - 7 Reports
    pulmonary infiltration - 7 Reports hypoglycaemia - 7 Reports renal failure nos - 7 Reports head pressure - 7 Reports
    suffocation feeling - 7 Reports pain legs - 7 Reports pulse irregularity nos - 7 Reports wheezing expiratory - 7 Reports
    anaemia haemolytic - 7 Reports pricking skin sensation - 7 Reports erythroderma - 7 Reports visual disturbance - 7 Reports
    neck tightness - 7 Reports fear - 7 Reports joint ache - 7 Reports movements reduced - 7 Reports
    shivers - 7 Reports eyes rolling - 7 Reports extremities hot feeling of - 7 Reports swelling auricular - 7 Reports
    eye burns - 7 Reports abscess - 7 Reports palmar-plantar erythrodysaesth. - 7 Reports antibodies drug specific - 7 Reports
    dysaesthesia - 7 Reports melaena - 6 Reports nightmares - 6 Reports taste perversion - 6 Reports
    convulsions grand mal - 6 Reports glossitis - 6 Reports thirst - 6 Reports teeth-grinding - 6 Reports
    sensory disturbance - 6 Reports injection site mass - 6 Reports embolism pulmonary - 6 Reports epiphora - 6 Reports
    mucosal swelling - 6 Reports withdrawal syndrome - 6 Reports urticaria acute - 6 Reports mydriasis - 6 Reports
    paraesthesia skin - 6 Reports skin erythema desquamative - 6 Reports bloating - 6 Reports neuroleptic malignant syndrome - 6 Reports
    qt prolonged - 6 Reports sinus tachycardia - 6 Reports mucositis nos - 6 Reports movements involuntary - 6 Reports
    nephritis interstitial - 6 Reports giant urticaria - 6 Reports rhinorrhoea - 6 Reports urinary tract infection - 6 Reports
    herpes zoster - 6 Reports arterial blood pressure decreased - 6 Reports pleural effusion - 6 Reports rhabdomyolysis - 6 Reports
    breathing abnormally shallow - 6 Reports oedema pulmonary - 6 Reports pupils dilated - 6 Reports infection viral - 6 Reports
    bowel obstruction - 6 Reports weight increase - 5 Reports alopecia - 5 Reports epidermal necrolysis - 5 Reports
    parkinson's syndrome - 5 Reports aphonia - 5 Reports diplopia - 5 Reports flatulence - 5 Reports
    epistaxis - 5 Reports oral mucosal eruption - 5 Reports tachycardia ventricular - 5 Reports personality disorder - 5 Reports
    skin inflammation nos - 5 Reports respiratory insufficiency - 5 Reports thrombocytosis - 5 Reports tongue discolouration - 5 Reports
    cheilitis - 5 Reports stomatitis ulcerative - 5 Reports tremor limb - 5 Reports stroke - 5 Reports
    exophthalmos - 5 Reports cpk increased - 5 Reports hyperaemia - 5 Reports red neck syndrome - 5 Reports
    allergy - 5 Reports respiration labored - 5 Reports accidental overdose - 5 Reports application site oedema - 5 Reports
    skin ulceration - 5 Reports vaginal itching - 5 Reports burning feeling vagina - 5 Reports pain right upper quadrant - 5 Reports
    glands swollen - 5 Reports haemorrhage nos - 5 Reports heart failure - 5 Reports gasping - 5 Reports
    gagging - 5 Reports crackles - 5 Reports chest burning pain of - 5 Reports memory loss - 5 Reports
    polyarthritis generalized - 5 Reports muscle contractions involuntary - 5 Reports sensation of cold - 5 Reports suicide attempt - 5 Reports
    agranulocytosis - 5 Reports reticulocytosis - 5 Reports nose oedema - 5 Reports exanthema - 5 Reports
    dyskinesia tardive - 4 Reports coordination abnormal - 4 Reports rales - 4 Reports gastritis - 4 Reports
    erythema nodosum - 4 Reports mentation impaired - 4 Reports skin nodule - 4 Reports tongue paralysis - 4 Reports
    ecg abnormal - 4 Reports hyperkalaemia - 4 Reports nystagmus - 4 Reports polyuria - 4 Reports
    tongue inflammation - 4 Reports ear disorder nos - 4 Reports hyperactivity - 4 Reports conjunctival oedema - 4 Reports
    pain groin - 4 Reports respiratory failure - 4 Reports paralysis facial - 4 Reports gingival swelling - 4 Reports
    concentration impaired - 4 Reports immunoglobulins increased - 4 Reports pain in face - 4 Reports vaginal haemorrhage - 4 Reports
    perspiration excessive - 4 Reports weakness voluntary muscle - 4 Reports tonic/ clonic convulsions - 4 Reports chest fullness of - 4 Reports
    back discomfort - 4 Reports rash ecchymotic - 4 Reports increased stool urgency - 4 Reports abdominal pain lower - 4 Reports
    hair loss - 4 Reports pericarditis - 4 Reports tremulousness nervous - 4 Reports infection staphylococcal - 4 Reports
    cardiac failure - 4 Reports prothrombin time prolonged - 4 Reports pancytopenia - 4 Reports pericardial effusion - 4 Reports
    back ache - 4 Reports rash acneiform - 4 Reports thoracic pain - 4 Reports oesophagitis - 4 Reports
    sleep disturbed - 4 Reports healing impaired - 4 Reports diabetes mellitus - 4 Reports thrombosis - 4 Reports
    cramps - 4 Reports red man syndrome - 4 Reports blood in stool - 4 Reports upper resp tract infection - 4 Reports
    gastro-intestinal disorder nos - 4 Reports erythrocytes abnormal - 4 Reports breathing arrested - 4 Reports hernia nos - 4 Reports
    lymph nodes enlarged - 4 Reports hepatic function abnormal - 3 Reports excitability - 3 Reports haematemesis - 3 Reports
    dermatitis medicamentosa - 3 Reports neuropathy - 3 Reports le syndrome - 3 Reports dermatitis lichenoid - 3 Reports
    croup - 3 Reports oesophagospasm - 3 Reports pruritus genital - 3 Reports electrolyte abnormality - 3 Reports
    muscle cramp - 3 Reports vascular disorder - 3 Reports memory impairment - 3 Reports delusion - 3 Reports
    aphasia - 3 Reports blepharitis - 3 Reports emotional lability - 3 Reports hallucination auditory - 3 Reports
    sleep disorder - 3 Reports peripheral ischaemia - 3 Reports ear pain - 3 Reports pruritus ani - 3 Reports
    septicaemia - 3 Reports hyperkinesia - 3 Reports gi haemorrhage - 3 Reports migraine - 3 Reports
    lymphocytosis - 3 Reports ecg abnormal specific - 3 Reports unconscious partial - 3 Reports fibrillation ventricular - 3 Reports
    parkinsonism - 3 Reports eye discharge - 3 Reports coldness local - 3 Reports hyperhidrosis - 3 Reports
    joint effusion - 3 Reports lips dry - 3 Reports acidosis - 3 Reports tendon disorder - 3 Reports
    glottic oedema - 3 Reports cerebral haemorrhage - 3 Reports oedema cerebral - 3 Reports hyponatraemia - 3 Reports
    c-reactive protein positive - 3 Reports sleep difficult - 3 Reports swallowing painful - 3 Reports haemolysis - 3 Reports
    monocytosis - 3 Reports akinesia - 3 Reports hepatitis cholestatic - 3 Reports restless legs - 3 Reports
    vasodilation - 3 Reports fracture pathological - 3 Reports lip soreness - 3 Reports scar - 3 Reports
    pulse abnormal - 3 Reports serotonin syndrome - 3 Reports bladder discomfort - 3 Reports amnesia - 3 Reports
    tongue ulceration - 3 Reports hyperpyrexia - 3 Reports ascites - 3 Reports myoclonic jerks - 3 Reports
    altered state of consciousness - 3 Reports autoimmune disorder nos - 3 Reports conjunctival congestion - 3 Reports dry eyes - 3 Reports
    retrosternal pain - 3 Reports injection site bruising - 3 Reports antinuclear factor - 3 Reports chest pain substernal - 3 Reports
    drug abuse - 3 Reports antinuclear factor test positive - 3 Reports blindness temporary - 3 Reports feeling floating - 3 Reports
    hypothyroidism - 3 Reports tongue white - 3 Reports oppression - 3 Reports paraesthesia distal - 3 Reports
    arthritis rheumatoid aggravated - 3 Reports appetite lost - 3 Reports chronic obstruct airways disease - 3 Reports infection bacterial - 3 Reports
    hearing decreased - 3 Reports salicylism - 3 Reports weariness - 3 Reports urea blood level increased - 3 Reports
    inflammatory swelling - 3 Reports thrush - 3 Reports lupus erythematosus systemic - 3 Reports intestinal fistula - 3 Reports
    giant hives - 3 Reports chemosis - 3 Reports touch sensitivity increased - 3 Reports pruritus vulvae - 3 Reports
    facial palsy - 3 Reports tachycardia supraventricular - 3 Reports thrombosis venous deep - 3 Reports mobility decreased - 3 Reports
    headache vascular - 2 Reports hyperuricaemia - 2 Reports hepatomegaly - 2 Reports oliguria - 2 Reports
    vestibular disorder - 2 Reports somnambulism - 2 Reports vaginitis - 2 Reports apprehension - 2 Reports
    proteinuria - 2 Reports haematoma - 2 Reports vasoconstriction - 2 Reports colitis pseudomembranous - 2 Reports
    lymphadenitis - 2 Reports hypoventilation - 2 Reports gum hyperplasia - 2 Reports hypocalcaemia - 2 Reports
    syncope postural - 2 Reports drug dependence - 2 Reports psoriasis aggravated - 2 Reports photosensitivity allergic react - 2 Reports
    glaucoma - 2 Reports calcium blood decreased - 2 Reports otitis media - 2 Reports rhonchi - 2 Reports
    faeces pale - 2 Reports dermatitis atopic - 2 Reports hysteria - 2 Reports tooth disorder - 2 Reports
    eructation - 2 Reports dermographia - 2 Reports depersonalization - 2 Reports phlebitis superficial - 2 Reports
    fixed eruption - 2 Reports bone disorder - 2 Reports otitis externa - 2 Reports miosis - 2 Reports
    rash follicular - 2 Reports spasm generalized - 2 Reports arthritis aggravated - 2 Reports arrhythmia ventricular - 2 Reports
    therapeutic response increased - 2 Reports breath holding - 2 Reports extravasation - 2 Reports euphoria - 2 Reports
    skin hyperpigmentation - 2 Reports halitosis - 2 Reports faeces discoloured - 2 Reports carpal tunnel syndrome - 2 Reports
    synovitis - 2 Reports cystitis - 2 Reports telangiectasis - 2 Reports allergy aggravated - 2 Reports
    skin depigmentation - 2 Reports tonsillitis - 2 Reports tachycardia atrial - 2 Reports resp gas exchange disorder nos - 2 Reports
    gingivitis - 2 Reports pulmonary haemorrhage - 2 Reports aspiration - 2 Reports dysgeusia - 2 Reports
    skin chapped - 2 Reports amylase increased - 2 Reports platelets increased - 2 Reports vein discolouration - 2 Reports
    blood urea increased - 2 Reports platelet production decreased - 2 Reports dermatitis eczematoid - 2 Reports respiratory rate decreased - 2 Reports
    ear ringing - 2 Reports pyuria - 2 Reports dermatographia - 2 Reports lymphopenia - 2 Reports
    tissue puffing - 2 Reports micturition burning - 2 Reports chest congestion - 2 Reports erythrocyte sedimentation incr - 2 Reports
    diarrhoea bloody - 2 Reports ill feeling - 2 Reports head pain - 2 Reports hemiplegia - 2 Reports
    infection fungal - 2 Reports epigastric food-related pain - 2 Reports gastroenteritis - 2 Reports behaviour hyperactive - 2 Reports
    impulsive behaviour - 2 Reports hot dry skin - 2 Reports npn increased - 2 Reports acidosis lactic - 2 Reports
    multiple organ failure - 2 Reports drug withdrawal syndrome - 2 Reports hypertension aggravated - 2 Reports raynaud's phenomenon - 2 Reports
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